A Phase 1 interventional study of Niraparib and TSR-042 in Neoplasms, Metastatic Cancer and Advanced Cancer, sponsored by Tesaro, Inc.. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-25.
Sponsored by Tesaro, Inc. (part of GlaxoSmithKline) · Phase 1, Interventional, and Treatment
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Among 50 studies in Carcinoma, Non-Small-Cell Lung by GlaxoSmithKline — none open to participants now, 6 under way, 2 of them phase 3. Carcinoma, Non-Small-Cell Lung · GlaxoSmithKline.
Among the 50 studies in Carcinoma, Non-Small-Cell Lung by GlaxoSmithKline, this one is the 27th largest by enrollment of the 45 interventional ones that give a count, is one of 2 that started in 2017, is one of 17 in phase 1, and was the 38th registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →None of the 50 studies in Carcinoma, Non-Small-Cell Lung by GlaxoSmithKline is open now. The open studies under Carcinoma, Non-Small-Cell Lung, anywhere →
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
50 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 21 · Phase 2 23 · Phase 3 7
First in 2000; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 60 is close to the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 88 across the 45 interventional studies, 1 across the 3 observational. Of the 41 that completed or were terminated, 22 (54%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Tesaro, Inc., one of the names counted as GlaxoSmithKline. Under that name alone:
Tesaro, Inc. is the lead sponsor of 33 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 12 (100%) have results posted.
1 of the studies in Carcinoma, Non-Small-Cell Lung by GlaxoSmithKline that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT02817633Tesaro, Inc.A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) | 2027-03-01 |
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Among the 50 studies in Carcinoma, Non-Small-Cell Lung by GlaxoSmithKline, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Part A: To test the safety and tolerability of combination therapy with Niraparib and TSR-042 and to establish a safe dose that will be used in a Phase 2 study.
Part B: To test the safety and tolerability of combination therapy with Carboplatin-Paclitaxel and TSR-042 and to establish a safe dose that will be used in a Phase 2 study.
Part C: To test the safety and tolerability of combination therapy with Niraparib, TSR-042 and Bevacizumab and to establish a safe dose that will be used in a Phase 2 study.
Part D: To test the safety and tolerability of combination therapy with Carboplatin-Paclitaxel, TSR-042 and Bevacizumab and to establish a safe dose that will be used in a Phase 2 study.
Part E: To test the safety and tolerability of combination therapy with Carboplatin-Pemetrexed and TSR-042 and to establish a safe dose that will be used in a Phase 2 study.
Part F: To test the safety and tolerability of combination therapy with Carboplatin-Pemetrexed, TSR-022 and TSR-042 and to establish a safe dose that will be used in a Phase 2 study.
Part G: To test the safety and tolerability of combination therapy with Carboplatin-nab-Paclitaxel, TSR-042 and to establish a safe dose that will be used in a Phase 2 study.
Part H: To test the safety and tolerability of combination therapy with Carboplatin-nab-Paclitaxel, TSR-022 and TSR-042 and to establish a safe dose that will be used in a Phase 2 study.
Part I: To test the safety and tolerability of combination therapy with Carboplatin-Paclitaxel, TSR-022 and TSR-042 and to establish a safe dose that will be used in a Phase 2 study.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
This study's enrollment of 60 is close to the median of 62 across 6,023 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →Tesaro, Inc. is the lead sponsor of 33 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 12 (100%) have results posted.
First submitted before Tesaro, Inc. became part of GlaxoSmithKline.
Compared within Carcinoma, Non-Small-Cell Lung, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Inclusion Criteria:
For Part A and C, in addition to the general inclusion criteria, patients must also meet the following additional criterion to be considered eligible to participate in this study:
Exclusion Criteria: (Patients will not be eligible for the study entry if any of the following criteria are met)
Note: No data are available regarding the presence of niraparib or its metabolites in human milk, or on its effects on the breastfed infant or milk production. Because of the potential for serious adverse reactions in breastfed infants from niraparib, female patients should not breastfeed during treatment with niraparib and for 1 month after receiving the final dose.
For Parts B, D, E, F, G, H, and I, patients will not be eligible for study entry if any of the following additional exclusion criterion are met:
For Parts C and D only, patients will not be eligible for study entry if the following additional exclusion criterion is met:
For Parts E and F only, patients will not be eligible for study entry if any of the following additional exclusion criteria are met:
For Parts G, H, and I only, patients will not be eligible for study entry if any of the following additional exclusion criteria are met:
For Parts E, F, G, H and I only, patients will not be eligible for study entry if any of the following additional exclusion criteria are met:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive TSR-042 500 milligram (mg), intravenous (IV) infusion on Day 1 of every cycle (every 3 weeks \[Q3W\]) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (every 6 weeks \[Q6W\]) beginning on Day 1 of Cycle 5 along with niraparib 200 mg, once daily (QD), orally on Days 1 to 21 repeated Q3W.
Drug: Niraparib · Drug: TSR-042
Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg, QD, orally on Days 1 to 21 repeated Q3W.
Drug: Niraparib · Drug: TSR-042
Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 milligram per square meter (mg/m\^2), IV infusion on Day 1 Q3W administered for 4 to 6 cycles.
Drug: TSR-042 · Drug: Carboplatin-Paclitaxel
Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 200 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kilogram (kg), IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Drug: Niraparib · Drug: TSR-042 · Drug: Bevacizumab
Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with niraparib 300 mg administered orally on Days 1 to 21 repeated Q3W and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Drug: Niraparib · Drug: TSR-042 · Drug: Bevacizumab
Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) for 4 cycles (each cycle is 21 days); followed by TSR-042 1000 mg, IV infusion on Day 1 of every other cycle (Q6W) beginning on Day 1 of Cycle 5 along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W administered for 4 to 6 cycles; and bevacizumab 15 mg/kg, IV infusion on Day 1 of every 21-day cycle Q3W for up to 15 months.
Drug: TSR-042 · Drug: Carboplatin-Paclitaxel · Drug: Bevacizumab
Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation) administered for 6 cycles (each cycle is 21 days).
Drug: TSR-042 · Drug: Carboplatin-Pemetrexed
Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); and TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W administered for 5 cycles (each cycle is 21 days); and pemetrexed 500 mg/m\^2, IV infusion on Day 1 Q3W (with vitamin supplementation).
Drug: TSR-042 · Drug: TSR-022 · Drug: Carboplatin-Pemetrexed
Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W) along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle is 21 days) and nab-paclitaxel 100 mg/m\^2, IV infusion on Days 1, 8 and 15 (every week \[Q1W\]) of every 3 week cycle for 4 to 6 cycles.
Drug: TSR-042 · Drug: Carboplatin-Nab-Paclitaxel
Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle is 21 days) and nab-paclitaxel 100 mg/m\^2, IV infusion on Days 1, 8 and 15 (Q1W) of every 3 week cycle for 4 to 6 cycles.
Drug: TSR-042 · Drug: TSR-022 · Drug: Carboplatin-Nab-Paclitaxel
Patients will receive TSR-042 500 mg, IV infusion on Day 1 of every cycle (Q3W); followed by TSR-022 900 mg, IV infusion on Day 1 Q3W along with carboplatin, IV infusion on Day 1 Q3W and paclitaxel 175 mg/m\^2, IV infusion on Day 1 Q3W for 4 to 6 cycles (each cycle is 21 days).
Drug: TSR-042 · Drug: Carboplatin-Paclitaxel · Drug: TSR-022
Niraparib is a potent, orally active PARP1 and PARP2 inhibitor being developed as a treatment for patients with tumors that harbor defects in the homologous recombination DNA repair pathway or that are driven by PARP-mediated transcription factors.
Also known as: Zejula
TSR-042 is a humanized monoclonal antibody that binds with high affinity to PD-1 resulting in inhibition of binding to programmed death receptor ligands 1 and 2 (PD-L1 and PD-L2).
Carboplatin in combination with paclitaxel is a chemotherapy treatment that has been shown to be efficacious against a variety of different tumor types, including non-small cell lung cancer \[NSCLC\], ovarian cancer, endometrial cancer, and head and neck cancer.
Bevacizumab is a chemotherapy treatment that has been shown to be efficacious against a variety of different cancer types, including colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma. Bevacizumab is in the angiogenesis inhibitor and monoclonal antibody families of medication. It works by slowing the growth of new blood vessels.
Also known as: Avastin
TSR-022 is a monoclonal antibody against TIM-3 (also called HAVCR2), an immune checkpoint receptor. Immune checkpoint proteins are molecules that help to regulate the immune system so it does not mistakenly attack healthy cells. However, they can also keep immune cells from recognizing and killing cancer cells. TIM-3 is found on the surface of certain T-cells, including tumor-infiltrating T-cells, that have left the bloodstream and migrated into the tumor environment. By binding to and blocking TIM-3, TRS-022 allows for T-cells to become activated so as to enhance T-cell-mediated attacks on tumors. These attacks reduce their growth.
Pemetrexed and platinum therapy in combination with pembrolizumab (anti-PD-1 antibody) has proven to be efficacious in a first line setting for nonsquamous NSCLC patients
Nab-paclitaxel is a formulation of paclitaxel that is indicated for locally advanced or metastatic NSCLC, as first-line treatment in combination with carboplatin in patients who are not candidates for curative surgery or radiation therapy. Nab-paclitaxel has shown increased ORR and time to progression in metastatic breast cancer compared with solvent-based paclitaxel and has shown antitumor activity and improved ORR compared with solvent-based paclitaxel as first-line therapy in patients with NSCLC.
Part A: Number of Participants With Dose-limiting Toxicity (DLT)
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of adverse event(AE) onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish recommended phase 2 dose (RP2D).
Time frame: 21 days
Part B: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
Time frame: 21 days
Part C: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
Time frame: 21 days
Part D: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
Time frame: 21 days
Part E: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
Time frame: 21 days
Part F: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
Time frame: 21 days
Part G: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.
Time frame: 21 days
Part H: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.
Time frame: 21 days
Part I: Number of Participants With DLT
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.
Time frame: 21 days
Part A: Number of Participants With Non-serious Treatment-emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs) and Adverse Events of Special Interest (AESIs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Time frame: Up to 28.5 months
Part B: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Time frame: Up to 28.5 months
Part C: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Time frame: Up to 22.5 months
Part D: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Time frame: Up to 9.5 months
Part E: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Time frame: Up to 4.4 months
Part F: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
Time frame: Up to 3.5 months
Part G: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
Time frame: Up to 24 months
Part H: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
Time frame: Up to 24 months
Part I: Number of Participants With Non-serious TEAEs, STEAEs and AESIs
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
Time frame: Up to 24 months
Part A: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed complete response (CR) or partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis. PR=At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Time frame: Up to 28.5 months
Part B: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Time frame: Up to 28.5 months
Part C: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Time frame: Up to 22.5 months
Part D: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Time frame: Up to 9.5 months
Part E: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Time frame: Up to 4.4 months
Part F: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Time frame: Up to 3.5 months
Part G: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Time frame: Up to 24 months
Part H: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Time frame: Up to 24 months
Part I: Objective Response Rate
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
Time frame: Up to 24 months
Part A: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Time frame: Up to 28.5 months
Part B: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Time frame: Up to approximately 66 months
Part C: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Time frame: Up to approximately 60 months
Part D: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Time frame: Up to approximately 62.5 months
Part E: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Time frame: Up to 4.4 months
Part F: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Time frame: Up to 3.5 months
Part G: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Time frame: Up to 24 months
Part H: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Time frame: Up to 24 months
Part I: Duration of Response
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
Time frame: Up to 24 months
Part A: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or stable disease (SD) per RECIST version 1.1.
Time frame: Up to 28.5 months
Part B: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Time frame: Up to 28.5 months
Part C: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Time frame: Up to 22.5 months
Part D: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Time frame: Up to 9.5 months
Part E: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Time frame: Up to 4.4 months
Part F: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Time frame: Up to 3.5 months
Part G: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Time frame: Up to 24 months
Part H: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Time frame: Up to 24 months
Part I: Disease Control Rate
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
Time frame: Up to 24 months
Part A: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Time frame: Up to 28.5 months
Part B: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Time frame: Up to 28.5 months
Part C: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Time frame: Up to 22.5 months
Part D: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Time frame: Up to 9.5 months
Part E: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Time frame: Up to 4.4 months
Part F: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
Time frame: Up to 3.5 months
Part G: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.
Time frame: Up to 24 months
Part H: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.
Time frame: Up to 24 months
Part I: Progression-free Survival
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.
Time frame: Up to 24 months
Part A: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay). Anti-drug Antibody Population consisted of all participants who received at least 1 dose of study treatment and had provided a pre-dose blood sample and at least 1 post-dose blood sample at or after 96 hours.
Time frame: Up to 28.5 months
Part B: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Time frame: Up to 28.5 months
Part C: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Time frame: Up to 22.5 months
Part D: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Time frame: Up to 9.5 months
Part E: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Time frame: Up to 4.4 months
Part F: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Time frame: Up to 3.5 months
Part F: Number of Participants With Positive Anti-TSR-022 Antibodies
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Time frame: Up to 3.5 months
Part G: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planeed to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Time frame: Up to 24 months
Part H: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Time frame: Up to 24 months
Part H: Number of Participants With Positive Anti-TSR-022 Antibodies
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Time frame: Up to 24 months
Part I: Number of Participants With Positive Anti-TSR-042 Antibodies
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Time frame: Up to 24 months
Part I: Number of Participants With Positive Anti-TSR-022 Antibodies
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
Time frame: Up to 24 months
Part A: Area Under the Plasma Concentration From Time Zero to t (AUC[0-t]) of Niraparib
Blood samples were collected at indicated time points. Pharmacokinetic (PK) parameters of niraparib were calculated using non-compartmental methods. PK population consisted of all participants who received at least 1 dose of study treatment and had at least 1 PK sample.
Time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
Part A: AUC(0-t) of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part B: AUC0-t of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part C: AUC0-t of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
Part C: AUC0-t of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part D: AUC0-t of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part E: AUC0-t of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)
Part F: AUC0-t of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part F: AUC0-t of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part G: AUC0-t of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)
Part H: AUC0-t of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part H: AUC0-t of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part I: AUC0-t of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part I: AUC0-t of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part A: Area Under the Plasma Concentration From Time Zero to Infinity (AUC[0-infinity]) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
Part A: AUC(0-infinity) of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part B: AUC(0-infinity) of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part C: AUC(0-infinity) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
Part C: AUC(0-infinity) of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part D: AUC(0-infinity) of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part E: AUC(0-infinity) of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)
Part F: AUC(0-infinity) of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part F: AUC(0-infinity) of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
Part G: AUC(0-infinity) of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)
Part H: AUC(0-infinity) of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part H: AUC(0-infinity) of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part I: AUC(0-infinity) of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part I: AUC(0-infinity) of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part A: Observed Concentration at the End of the Dosing Interval (Ctau) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
Part A: Ctau of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
Part B: Ctau of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
Part C: Ctau of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
Part C: Ctau of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
Part D: Ctau of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
Part E: Ctau of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part F: Ctau of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part F: Ctau of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part G: Ctau of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part H: Ctau of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
Part H: Ctau of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
Part I: Ctau of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
Part I: Ctau of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
Part A: Maximum Observed Plasma (Cmax) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
Part A: Cmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
Part B: Cmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
Part C: Cmax of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
Part C: Cmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
Part D: Cmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
Part E: Cmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part F: Cmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part F: Cmax of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
Part G: Cmax of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part H: Cmax of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
Part H: Cmax of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
Part I: Cmax of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
Part I: Cmax of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
Part A: Clearance After Oral Administration (CL/F) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
Part A: Clearance After Intravenous Administration (CL) of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part B: CL of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part C: CL/F of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
Part C: CL of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part D: CL of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part E: CL of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)
Part F: CL of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part F: CL of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part G: CL of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)
Part H: CL of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part H: CL of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part I: CL of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part I: CL of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part A: Volume of Distribution After Oral Administration (Vz/F) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
Part A: Volume of Distribution After Intravenous Administration (Vz) of of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part B: Vz of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part C: Vz/F of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Time frame: Cycles 1 and 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
Part C: Vz of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part D: Vz of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycles 1 and 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part E: Vz of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)
Part F: Vz of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part F: Vz of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part G: Vz of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycles 1 and 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose; Cycle 2: Pre-dose (each cycle was 21 days)
Part H: Vz of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part H: Vz of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part I: Vz of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part I: Vz of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose; Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part A: AUC at Steady State (AUCss) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
Part A: AUCss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part B: AUCss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part C: AUCss of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
Part C: AUCss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part D: AUCss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part E: AUCss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose (each cycle was 21 days)
Part F: AUCss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part F: AUCss of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part G: AUCss of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part H: AUCss of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part H: AUCss of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part I: AUCss of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part I: AUCss of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part A: Ctau at Steady State (Ctau,ss) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)
Part A: Ctau,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part B: Ctau,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part C: Ctau,ss of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)
Part C: Ctau,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part D: Ctau,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part E: Ctau,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose (each cycle was 21 days)
Part F: Ctau,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part F: Ctau,ss of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part G: Ctau,ss of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part H: Ctau,ss of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part H: Ctau,ss of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part I: Ctau,ss of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part I: Ctau,ss of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part A: Cmax at Steady State (Cmax,ss) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)
Part A: Cmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part B: Cmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part C: Cmax,ss of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)
Part C: Cmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part D: Cmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part E: Cmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose (each cycle was 21 days)
Part F: Cmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part F: Cmax,ss of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part G: Cmax,ss of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part H: Cmax,ss of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part H: Cmax,ss of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part I: Cmax,ss of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part I: Cmax,ss of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part A: Time to Reach Maximum Plasma Concentration (Tmax) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
Part A: Tmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
Part B: Tmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
Part C: Tmax of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose (each cycle was 21 days)
Part C: Tmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
Part D: Tmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose (each cycle was 21 days)
Part E: Tmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part F: Tmax of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part F: Tmax of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part G: Tmax of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part H: Tmax of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
Part H: Tmax of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
Part I: Tmax of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
Part I: Tmax of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 1: Pre-dose, 0.5, 1, 2, 3, 24, 48, 96, 168 and 336 hours post-dose (each cycle was 21 days)
Part A: Tmax at Steady State (Tmax,ss) of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)
Part A: Tmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part B: Tmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part C: Tmax,ss of Niraparib
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post-dose; Cycles 5 and 11: Pre-dose, 2 hours post-dose (each cycle was 21 days)
Part C: Tmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part D: Tmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part E: Tmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose (each cycle was 21 days)
Part F: Tmax,ss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part F: Tmax,ss of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part G: Tmax,ss of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part H: Tmax,ss of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part H: Tmax,ss of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part I: Tmax,ss of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part I: Tmax,ss of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part A: Volume of Distribution After Intravenous Administration (Vss) of of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part B: Vss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part C: Vss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part D: Vss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 4: Pre-dose, 0.5, 2, 24, 96, 168, 336 and 504 hours post-dose; Cycles 5 and 11: Pre-dose, 0.5, 2, 24, 96, 168, 336, 504 and 1008 hours post-dose (each cycle was 21 days)
Part E: Vss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose (each cycle was 21 days)
Part F: Vss of TSR-042
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part F: Vss of TSR-022
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part G: Vss of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part H: Vss of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part H: Vss of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part I: Vss of TSR-042
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
Part I: Vss of TSR-022
Blood samples were planned to be collected at indicated time points.
Time frame: Cycle 2: Pre-dose; Cycle 5: Pre-dose, 0.5, 2, 24, 48, 96, 168, and 336 hours post-dose (each cycle was 21 days)
A total of 60 participants were enrolled in the study and 2 participants who originally signed inform consent form (ICF) withdrew their consent shortly from study before treatment assignment and a total of 58 participants were part of the study.
| Milestone | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed | Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel | Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel | Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel | PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel | PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 16 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 16 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Disease progression | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 7 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 4 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed | Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel | Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel | Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel | PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel | PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 14 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 14 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Disease progression | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 0 | 0 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Transitioned to pact phase | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed | Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel | Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel | Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel | PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel | PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 6 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 6 | 7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 0 | 0 | 0 | 2 | 5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Went on another clinical trial | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed | Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel | Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel | Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel | PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel | PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Transitioned to pact phase | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Completed eot and began new study | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed | Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel | Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel | Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel | PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel | PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed | Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel | Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel | Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel | PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel | PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Physician decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed | Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel | Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel | Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel | PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel | PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed | Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel | Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel | Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel | PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel | PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed | Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel | Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel | Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel | PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel | PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed | Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel | Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel | Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel | PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel | PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of adverse event(AE) onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish recommended phase 2 dose (RP2D).
| Participants | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Part A: Number of Participants With Dose-limiting Toxicity (DLT) | 2 | 0 |
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
| Participants | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel |
|---|---|
| Part B: Number of Participants With DLT | 1 |
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
| Participants | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Part C: Number of Participants With DLT | 1 | 1 |
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
| Participants | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|
| Part D: Number of Participants With DLT | 0 |
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
| Participants | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed |
|---|---|
| Part E: Number of Participants With DLT | 0 |
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were collected during first cycle to establish RP2D.
| Participants | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Number of Participants With DLT | 0 |
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.
No measurements were reported for this outcome.
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.
No measurements were reported for this outcome.
An event was considered a DLT if it occurred within the first 21 days of treatment, and met one of following DLT criteria:hematologic toxicity- Grade4 thrombocytopenia persists for \>=7 days from the time of AE onset, Grade 4 neutropenia, Grade 4 or Grade 3 febrile neutropenia persists for \>=7 days, Grade4 or Grade3 anemia requiring blood transfusion, Grade 3 thrombocytopenia associated with clinically significant bleeding, Grade 3 neutropenia associated with infection as described in CTCAE version 4.0, drug related Grade 3 or 4 non-hematologic toxicity, drug related Grade 3 or 4 nonhematologic laboratory abnormality if any of the following also occur: abnormality leads to hospitalization and abnormality persists for \>=7 days from the time of AE onset; drug related toxicity leading to prolonged delay (\>2 weeks) in initiating Cycle 2. DLTs were planned to be collected during first cycle to establish RP2D.
No measurements were reported for this outcome.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
| Participants | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Non-serious TEAEs | 16 | 6 |
| STEAEs | 11 | 4 |
| AESIs | 1 | 1 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
| Participants | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel |
|---|---|
| Non-Serious TEAEs | 14 |
| STEAEs | 9 |
| AESIs | 0 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
| Participants | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Non-serious TEAEs | 5 | 7 |
| STEAEs | 3 | 3 |
| AESIs | 0 | 0 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
| Participants | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|
| Non-serious TEAEs | 6 |
| STEAEs | 3 |
| AESIs | 0 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
| Participants | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed |
|---|---|
| Non-serious TEAEs | 2 |
| STEAEs | 2 |
| AESIs | 0 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment. Number of participants with TEAEs, SAEs and AESIs are reported.
| Participants | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Non-serious TEAEs | 1 |
| STEAEs | 0 |
| AESIs | 0 |
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
No measurements were reported for this outcome.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
No measurements were reported for this outcome.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. An SAE is defined as any untoward medical occurrence that, at any dose; results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgement. TEAE is any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.
No measurements were reported for this outcome.
Objective Response Rate is defined as the percentage of participants who achieved confirmed complete response (CR) or partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeters (mm) in the short axis. PR=At least a 30 percent (%) decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
| Percentage of participants | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Part A: Objective Response Rate | 25.0 | 0 |
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
| Percentage of participants | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel |
|---|---|
| Part B: Objective Response Rate | 42.9 |
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
| Percentage of participants | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Part C: Objective Response Rate | 50.0 | 14.3 |
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
| Percentage of participants | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|
| Part D: Objective Response Rate | 50.0 |
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
| Percentage of participants | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed |
|---|---|
| Part E: Objective Response Rate | 0 |
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
| Percentage of participants | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Objective Response Rate | 0 |
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
No measurements were reported for this outcome.
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
No measurements were reported for this outcome.
Objective Response Rate is defined as the percentage of participants who achieved confirmed CR or PR, evaluated using RECIST version 1.1 based on Investigator assessment; where CR=Disappearance of all target lesions. Any pathological lymph nodes must be \<10 mm in the short axis. PR=At least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters.
No measurements were reported for this outcome.
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
| Months | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Part A: Duration of Response | 7.59 (5.78 to 10.94) | NA (NA to NA) |
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
| Months | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel |
|---|---|
| Part B: Duration of Response | NA (NA to NA) |
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
| Months | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Part C: Duration of Response | NA (NA to NA) | NA (NA to NA) |
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
| Months | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|
| Part D: Duration of Response | NA (NA to NA) |
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
| Months | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed |
|---|---|
| Part E: Duration of Response | NA (NA to NA) |
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
| Months | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Duration of Response | NA (NA to NA) |
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
No measurements were reported for this outcome.
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
No measurements were reported for this outcome.
Duration of response is defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 or death by any cause.
No measurements were reported for this outcome.
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or stable disease (SD) per RECIST version 1.1.
| Percentage of participants | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Part A: Disease Control Rate | 43.8 | 33.3 |
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
| Percentage of participants | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel |
|---|---|
| Part B: Disease Control Rate | 57.1 |
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
| Percentage of participants | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Part C: Disease Control Rate | 83.3 | 85.7 |
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
| Percentage of participants | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|
| Part D: Disease Control Rate | 83.3 |
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
| Percentage of participants | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed |
|---|---|
| Part E: Disease Control Rate | 0 |
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
| Percentage of participants | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Disease Control Rate | 100 |
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
No measurements were reported for this outcome.
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
No measurements were reported for this outcome.
Disease Control Rate is defined as the percentage of participants who had achieved CR, PR, or SD per RECIST version 1.1.
No measurements were reported for this outcome.
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. Progressive Disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
| Months | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Part A: Progression-free Survival | 6.2 (2.2 to 9.9) | 2.8 (2.3 to 4.7) |
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
| Months | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel |
|---|---|
| Part B: Progression-free Survival | 17.6 (3.9 to NA) |
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
| Months | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Part C: Progression-free Survival | NA (8.5 to NA) | 9.1 (8.0 to 11.1) |
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
| Months | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|
| Part D: Progression-free Survival | 7.6 (7.4 to NA) |
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
| Months | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed |
|---|---|
| Part E: Progression-free Survival | NA (NA to NA) |
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study.
| Months | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Progression-free Survival | NA (NA to NA) |
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.
No measurements were reported for this outcome.
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.
No measurements were reported for this outcome.
Progression-free Survival is defined as the date of first dose to the date of disease progression or death due to any cause, whichever occurs earlier.
No measurements were reported for this outcome.
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay). Anti-drug Antibody Population consisted of all participants who received at least 1 dose of study treatment and had provided a pre-dose blood sample and at least 1 post-dose blood sample at or after 96 hours.
| Participants | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Part A: Number of Participants With Positive Anti-TSR-042 Antibodies | 0 | 0 |
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
| Participants | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel |
|---|---|
| Part B: Number of Participants With Positive Anti-TSR-042 Antibodies | 4 |
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
| Participants | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Part C: Number of Participants With Positive Anti-TSR-042 Antibodies | 0 | 0 |
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
| Participants | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|
| Part D: Number of Participants With Positive Anti-TSR-042 Antibodies | 0 |
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
| Participants | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed |
|---|---|
| Part E: Number of Participants With Positive Anti-TSR-042 Antibodies | 0 |
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
| Participants | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Number of Participants With Positive Anti-TSR-042 Antibodies | NA |
Serum samples were collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
| Participants | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Number of Participants With Positive Anti-TSR-022 Antibodies | NA |
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planeed to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
No measurements were reported for this outcome.
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
No measurements were reported for this outcome.
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
No measurements were reported for this outcome.
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-042. The presence of anti-TSR-042 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
No measurements were reported for this outcome.
Serum samples were planned to be collected at indicated time points and tested for the presence of antibodies that bind to TSR-022. The presence of anti-TSR-022 antibodies were planned to be assessed using a tiered approach using electrochemiluminescence (that is, screening, confirmation, titer, and neutralizing antibody assay).
No measurements were reported for this outcome.
Blood samples were collected at indicated time points. Pharmacokinetic (PK) parameters of niraparib were calculated using non-compartmental methods. PK population consisted of all participants who received at least 1 dose of study treatment and had at least 1 PK sample.
| Hours*microgram per milliliter | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Cycle 1, n=15,6 | 6.0430 ± 3.43261 | 7.8341 ± 4.76380 |
| Cycle 2, n=10,3 | 14.9172 ± 9.82689 | 29.3024 ± 2.15129 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Cycle 1, n=16,6 | 26827.7703 ± 9811.74994 | 29420.8347 ± 9262.18751 |
| Cycle 4, n=9,4 | 55408.3992 ± 21631.17124 | 29311.8182 ± 16546.73177 |
| Cycle 5, n=8,1 | 137108.2574 ± 41494.15474 | 141328.9288 ± NA |
| Cycle 11, n=5,0 | 139591.8834 ± 53844.12650 | — |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel |
|---|---|
| Cycle 1, n=14 | 28097.9846 ± 8440.50578 |
| Cycle 4, n=10 | 54730.0053 ± 15857.69305 |
| Cycle 5, n=9 | 124309.5455 ± 56505.10671 |
| Cycle 11, n=6 | 117030.4081 ± 33852.45635 |
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Cycle 1, n=6,7 | 3.4513 ± 1.23048 | 11.3601 ± 5.53524 |
| Cycle 2, n=4,4 | 14.7473 ± 8.11715 | 24.9691 ± 17.50367 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Cycle 1, n=6,7 | 29830.6542 ± 8143.36941 | 26311.1789 ± 4416.61957 |
| Cycle 4, n=5,7 | 54268.1379 ± 14777.09545 | 49198.8237 ± 12507.66126 |
| Cycle 5, n=5,6 | 137777.3188 ± 45794.21973 | 131281.9046 ± 36835.39730 |
| Cycle 11, n=4,2 | 143070.3093 ± 74219.00272 | 119161.8795 ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|
| Cycle 1, n=6 | 32819.5401 ± 9182.44511 |
| Cycle 4, n=5 | 52409.0255 ± 11814.13244 |
| Cycle 5, n=5 | 119847.0999 ± 27279.85524 |
| Cycle 11, n=4 | 77794.6422 ± 38680.64753 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed |
|---|---|
| Part E: AUC0-t of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: AUC0-t of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: AUC0-t of TSR-022 | NA ± NA |
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Part A: Area Under the Plasma Concentration From Time Zero to Infinity (AUC[0-infinity]) of Niraparib | NA ± NA | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Part A: AUC(0-infinity) of TSR-042 | NA ± NA | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel |
|---|---|
| Part B: AUC(0-infinity) of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Part C: AUC(0-infinity) of Niraparib | NA ± NA | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Part C: AUC(0-infinity) of TSR-042 | NA ± NA | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|
| Part D: AUC(0-infinity) of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed |
|---|---|
| Part E: AUC(0-infinity) of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: AUC(0-infinity) of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: AUC(0-infinity) of TSR-022 | NA ± NA |
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Part A: Observed Concentration at the End of the Dosing Interval (Ctau) of Niraparib | 0.191953 ± 0.1309536 | 0.342333 ± 0.3301392 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Part A: Ctau of TSR-042 | 33.6000 ± 12.25194 | 29.8000 ± 10.32570 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel |
|---|---|
| Part B: Ctau of TSR-042 | 33.9778 ± 9.89846 |
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Part C: Ctau of Niraparib | 0.161233 ± 0.1072328 | 0.478714 ± 0.4197538 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Part C: Ctau of TSR-042 | 37.2750 ± 16.78102 | 28.7500 ± 9.47505 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|
| Part D: Ctau of TSR-042 | 36.5250 ± 12.29834 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed |
|---|---|
| Part E: Ctau of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Ctau of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Ctau of TSR-022 | NA ± NA |
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Part A: Maximum Observed Plasma (Cmax) of Niraparib | 0.460600 ± 0.2401100 | 0.625667 ± 0.4547692 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Part A: Cmax of TSR-042 | 158.6875 ± 27.70251 | 138.9167 ± 37.87930 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel |
|---|---|
| Part B: Cmax of TSR-042 | 148.2000 ± 31.27948 |
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Part C: Cmax of Niraparib | 0.243667 ± 0.0889936 | 0.891571 ± 0.4638897 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Part C: Cmax of TSR-042 | 138.6667 ± 24.14677 | 158.4857 ± 48.36788 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|
| Part D: Cmax of TSR-042 | 188.5000 ± 36.04858 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed |
|---|---|
| Part E: Cmax of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Cmax of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Cmax of TSR-022 | NA ± NA |
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
| Liter per hour | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Cycle 1, n=1,0 | 28.5638 ± NA | — |
| Cycle 2, n=8,2 | 16.6295 ± 8.70836 | 10.2833 ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Liter per hour | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Cycle 4, n=7,2 | 0.0090 ± 0.00220 | 0.0110 ± NA |
| Cycle 5, n=8,1 | 0.0081 ± 0.00238 | 0.0071 ± NA |
| Cycle 11, n=4,0 | 0.0072 ± 0.00217 | — |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Liter per hour | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel |
|---|---|
| Cycle 4, n=10 | 0.0098 ± 0.00292 |
| Cycle 5, n=8 | 0.0082 ± 0.00242 |
| Cycle 11, n=6 | 0.0092 ± 0.00296 |
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
| Liter per hour | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Cycle 2, n=2,4 | 10.3777 ± NA | 14.4947 ± 8.40967 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Liter per hour | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Cycle 4, n=5,5 | 0.0100 ± 0.00441 | 0.0104 ± 0.00268 |
| Cycle 5, n=5,6 | 0.0082 ± 0.00370 | 0.0082 ± 0.00273 |
| Cycle 11, n=4,2 | 0.0079 ± 0.00391 | 0.0086 ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Liter per hour | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|
| Cycle 4, n=5 | 0.0102 ± 0.00210 |
| Cycle 5, n=5 | 0.0087 ± 0.00169 |
| Cycle 11, n=3 | 0.0104 ± 0.00100 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Liter per hour | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed |
|---|---|
| Part E: CL of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Liter per hour | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: CL of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
| Liter per hour | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: CL of TSR-022 | NA ± NA |
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
| Liter | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Cycle 1, n=1,0 | 380.1478 ± NA | — |
| Cycle 2, n=8,2 | 716.1418 ± 554.80278 | 487.8826 ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Liter | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Cycle 4, n=5,2 | 5.6925 ± 1.46062 | 10.3984 ± NA |
| Cycle 5, n=8,1 | 6.8811 ± 1.70545 | 6.3070 ± NA |
| Cycle 11, n=4,0 | 7.4795 ± 0.90952 | — |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Liter | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel |
|---|---|
| Cycle 4, n=10 | 5.3661 ± 2.01321 |
| Cycle 5, n=8 | 7.2627 ± 2.43311 |
| Cycle 11, n=6 | 8.0529 ± 3.64454 |
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
| Liter | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Cycle 2, n=2,2 | 551.4003 ± NA | 559.3634 ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Liter | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Cycle 4, n=5,5 | 6.6462 ± 2.66825 | 5.8922 ± 2.93257 |
| Cycle 5, n=4,6 | 6.1698 ± 1.73272 | 5.2066 ± 1.07206 |
| Cycle 11, n=4,2 | 9.6347 ± 4.05466 | 8.5098 ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Liter | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|
| Cycle 4, n=5 | 5.4955 ± 1.89543 |
| Cycle 5, n=5 | 6.1542 ± 1.57345 |
| Cycle 11, n=3 | 9.8356 ± 0.99107 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Liter | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed |
|---|---|
| Part E: Vz of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Liter | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Vz of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
| Liter | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Vz of TSR-022 | NA ± NA |
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Part A: AUC at Steady State (AUCss) of Niraparib | 16.3481 ± 10.63803 | 29.4312 ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Cycle 4, n=7,2 | 58598.5076 ± 15328.61731 | 46122.3924 ± NA |
| Cycle 5, n=8,1 | 135171.2753 ± 43806.32512 | 141306.3782 ± NA |
| Cycle 11, n=4,0 | 151575.3645 ± 55194.65972 | — |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel |
|---|---|
| Cycle 4, n=10 | 55073.0926 ± 15304.21896 |
| Cycle 5, n=8 | 130694.9752 ± 33923.75772 |
| Cycle 11, n=6 | 117033.3612 ± 33727.51653 |
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Part C: AUCss of Niraparib | 21.4926 ± NA | 26.5006 ± 14.61077 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Cycle 4, n=5,5 | 55974.4268 ± 16738.05254 | 50924.1510 ± 13339.28085 |
| Cycle 5, n=5,6 | 137399.5881 ± 45511.62023 | 131288.0291 ± 36816.18787 |
| Cycle 11, n=4,2 | 147907.5379 ± 60795.87607 | 119189.5905 ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|
| Cycle 4, n=5 | 51140.4410 ± 12597.07380 |
| Cycle 5, n=5 | 118845.3928 ± 27874.98871 |
| Cycle 11, n=3 | 96800.1534 ± 8871.32089 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed |
|---|---|
| Part E: AUCss of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: AUCss of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
| Hours*microgram per milliliter | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: AUCss of TSR-022 | NA ± NA |
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Cycle 2, n=11,6 | 0.507900 ± 0.3937657 | 0.622000 ± 0.4523848 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Cycle 4, n=8,1 | 77.3625 ± 28.55145 | 63.3000 ± NA |
| Cycle 5, n=8,1 | 68.5500 ± 34.63879 | 71.2000 ± NA |
| Cycle 11, n=4,0 | 93.8000 ± 47.28939 | — |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel |
|---|---|
| Cycle 4, n=9 | 67.2444 ± 24.15130 |
| Cycle 5, n=8 | 59.3000 ± 16.75913 |
| Cycle 11, n=6 | 57.4833 ± 20.98136 |
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Cycle 2, n=5,4 | 0.484000 ± 0.3511339 | 1.094250 ± 0.7660576 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Cycle 4, n=4,6 | 70.4250 ± 34.00896 | 64.2667 ± 23.55315 |
| Cycle 5, n=5,6 | 82.9800 ± 43.98252 | 53.1500 ± 24.80538 |
| Cycle 11, n=3,2 | 105.4667 ± 22.28909 | 60.9500 ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|
| Cycle 4, n=5 | 53.5200 ± 13.87271 |
| Cycle 5, n=5 | 48.0800 ± 23.95343 |
| Cycle 11, n=3 | 43.3000 ± 4.80729 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed |
|---|---|
| Part E: Ctau,ss of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Ctau,ss of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Ctau,ss of TSR-022 | NA ± NA |
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Cycle 2, n=10,3 | 0.925900 ± 0.6661597 | 1.706667 ± 0.0838650 |
| Cycle 5, n=7,0 | 0.839071 ± 0.6183628 | — |
| Cycle 11, n=2,0 | 0.768000 ± NA | — |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Cycle 4, n=9,4 | 222.5556 ± 51.37633 | 178.5000 ± 26.18524 |
| Cycle 5, n=8,1 | 393.8750 ± 100.81729 | 319.0000 ± NA |
| Cycle 11, n=5,0 | 405.4000 ± 103.69812 | — |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel |
|---|---|
| Cycle 4, n=10 | 225.8000 ± 51.71460 |
| Cycle 5, n=9 | 421.1111 ± 114.84603 |
| Cycle 11, n=6 | 446.6667 ± 160.53868 |
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Cycle 2, n=4,4 | 0.854500 ± 0.3934637 | 1.404750 ± 0.6642366 |
| Cycle 5, n=4,3 | 0.709750 ± 0.2693788 | 1.073667 ± 0.5474124 |
| Cycle 11, n=3,1 | 0.468333 ± 0.1418955 | 0.638000 ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Cycle 4, n=5,7 | 234.4000 ± 31.76948 | 227.1429 ± 42.65923 |
| Cycle 5, n=5,6 | 325.2000 ± 73.90332 | 417.3333 ± 139.40397 |
| Cycle 11, n=4,2 | 349.7500 ± 111.53886 | 321.0000 ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|
| Cycle 4, n=5 | 256.8000 ± 76.90709 |
| Cycle 5, n=5 | 416.0000 ± 89.43433 |
| Cycle 11, n=4 | 429.7500 ± 72.86231 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed |
|---|---|
| Part E: Cmax,ss of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Cmax,ss of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
| Microgram per milliliter | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Cmax,ss of TSR-022 | NA ± NA |
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
| Hours | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Part A: Time to Reach Maximum Plasma Concentration (Tmax) of Niraparib | 2.250 (1.75 to 7.02) | 4.083 (2.02 to 25.65) |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Part A: Tmax of TSR-042 | 0.817 (0.50 to 2.58) | 1.750 (0.50 to 23.17) |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel |
|---|---|
| Part B: Tmax of TSR-042 | 1.000 (0.55 to 27.28) |
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
| Hours | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Part C: Tmax of Niraparib | 3.975 (2.00 to 23.33) | 4.050 (2.05 to 22.60) |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Part C: Tmax of TSR-042 | 1.200 (0.50 to 4.48) | 0.583 (0.50 to 2.35) |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|
| Part D: Tmax of TSR-042 | 1.250 (0.50 to 25.17) |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed |
|---|---|
| Part E: Tmax of TSR-042 | NA (NA to NA) |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Tmax of TSR-042 | NA (NA to NA) |
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
| Hours | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Tmax of TSR-022 | NA (NA to NA) |
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
| Hours | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Cycle 2, n=10,3 | 4.008 (1.00 to 22.68) | 2.250 (2.08 to 7.00) |
| Cycle 5, n=7,0 | 2.000 (0.00 to 2.00) | — |
| Cycle 11, n=2,0 | 1.817 (1.75 to 1.88) | — |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Cycle 4, n=9,4 | 1.500 (0.50 to 2.07) | 1.300 (0.50 to 2.70) |
| Cycle 5, n=8,1 | 0.625 (0.50 to 1.73) | 2.783 (NA to NA) |
| Cycle 11, n=5,0 | 0.567 (0.50 to 2.00) | — |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel |
|---|---|
| Cycle 4, n=10 | 0.575 (0.50 to 2.08) |
| Cycle 5, n=9 | 1.500 (0.50 to 2.10) |
| Cycle 11, n=6 | 0.542 (0.42 to 2.07) |
Blood samples were collected at indicated time points. PK parameters of niraparib were calculated using non-compartmental methods.
| Hours | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Cycle 2, n=4,4 | 4.950 (2.03 to 22.30) | 3.958 (2.00 to 6.00) |
| Cycle 5, n=4,3 | 2.158 (1.82 to 2.68) | 1.967 (1.17 to 2.00) |
| Cycle 11, n=3,1 | 2.000 (0.00 to 2.00) | 2.083 (NA to NA) |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Cycle 4, n=5,7 | 1.517 (0.50 to 20.67) | 0.617 (0.50 to 2.00) |
| Cycle 5, n=5,6 | 2.083 (0.50 to 2.58) | 0.825 (0.50 to 2.25) |
| Cycle 11, n=4,2 | 2.000 (1.98 to 2.00) | 2.417 (2.17 to 2.67) |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|
| Cycle 4, n=5 | 0.500 (0.50 to 2.00) |
| Cycle 5, n=5 | 0.550 (0.50 to 2.00) |
| Cycle 11, n=4 | 0.500 (0.50 to 0.50) |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed |
|---|---|
| Part E: Tmax,ss of TSR-042 | NA (NA to NA) |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Hours | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Tmax,ss of TSR-042 | NA (NA to NA) |
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
| Hours | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Tmax,ss of TSR-022 | NA (NA to NA) |
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Liter | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD |
|---|---|---|
| Cycle 4, n=5,2 | 5.5647 ± 1.36694 | 9.8680 ± NA |
| Cycle 5, n=8,1 | 6.6580 ± 1.53521 | 5.9659 ± NA |
| Cycle 11, n=4,0 | 7.3107 ± 0.96007 | — |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Liter | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel |
|---|---|
| Cycle 4, n=10 | 5.1893 ± 1.80311 |
| Cycle 5, n=8 | 6.7701 ± 2.31992 |
| Cycle 11, n=6 | 7.4351 ± 2.78481 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Liter | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab |
|---|---|---|
| Cycle 4, n=5,5 | 6.4567 ± 2.68944 | 5.5177 ± 2.39652 |
| Cycle 5, n=4,6 | 6.2405 ± 1.79539 | 4.8035 ± 0.72905 |
| Cycle 11, n=4,2 | 8.9478 ± 3.05769 | 7.7750 ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Liter | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|
| Cycle 4, n=5 | 5.1493 ± 1.58340 |
| Cycle 5, n=5 | 5.6399 ± 1.41478 |
| Cycle 11, n=3 | 8.0614 ± 0.48037 |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Liter | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed |
|---|---|
| Part E: Vss of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-042 were calculated using non-compartmental methods.
| Liter | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Vss of TSR-042 | NA ± NA |
Blood samples were collected at indicated time points. PK parameters of TSR-022 were calculated using non-compartmental methods.
| Liter | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed |
|---|---|
| Part F: Vss of TSR-022 | NA ± NA |
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Blood samples were planned to be collected at indicated time points.
No measurements were reported for this outcome.
Collected over All-cause mortality, non-serious TEAEs and STEAEs were collected up to 28.5 months in Parts A; up to 66 months in Part B; up to 60 months in Part C; up to 62.5 months in Part D; up to 4.4 months in Part E; up to 3.5 months in Part F of main study and up to approximately 19 months for PACT phase.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Main Study: Part A: TSR-042 and Niraparib 200 mg QD | 4/16 (25%) | 11/16 (68.8%) | 16/16 (100%) |
| Main Study: Part A: TSR-042 and Niraparib 300 mg QD | 4/6 (66.7%) | 4/6 (66.7%) | 6/6 (100%) |
| Main Study: Part B: TSR-042 and Carboplatin-paclitaxel | 7/14 (50%) | 9/14 (64.3%) | 14/14 (100%) |
| Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | 2/6 (33.3%) | 3/6 (50%) | 5/6 (83.3%) |
| Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab | 5/7 (71.4%) | 3/7 (42.9%) | 7/7 (100%) |
| Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab | 1/6 (16.7%) | 3/6 (50%) | 6/6 (100%) |
| Main Study: Part E: TSR-042 and Carboplatin-pemetrexed | 1/2 (50%) | 2/2 (100%) | 2/2 (100%) |
| Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab | 1/1 (100%) | 1/1 (100%) | 0/1 (0%) |
| Event | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed | PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel | PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|---|---|---|---|---|---|---|---|---|
| General Medical DeteriorationGeneral disorders | 0/16 | 0/6 | 0/14 | 0/6 | 0/7 | 0/6 | 0/2 | 0/1 | 0/2 | 1/1 |
| PneumoniaInfections and infestations | 0/16 | 1/6 | 0/14 | 1/6 | 0/7 | 0/6 | 1/2 | 0/1 | 0/2 | 0/1 |
| Staphylococcal abscessInfections and infestations | 0/16 | 0/6 | 0/14 | 0/6 | 0/7 | 0/6 | 1/2 | 0/1 | 0/2 | 0/1 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 0/16 | 0/6 | 0/14 | 0/6 | 0/7 | 0/6 | 1/2 | 0/1 | 0/2 | 0/1 |
| NeutropeniaBlood and lymphatic system disorders | 0/16 | 1/6 | 0/14 | 0/6 | 0/7 | 0/6 | 0/2 | 0/1 | 0/2 | 0/1 |
| ThrombocytopeniaBlood and lymphatic system disorders | 2/16 | 1/6 | 0/14 | 0/6 | 0/7 | 0/6 | 0/2 | 0/1 | 0/2 | 0/1 |
| AstheniaGeneral disorders | 0/16 | 1/6 | 1/14 | 0/6 | 0/7 | 0/6 | 0/2 | 0/1 | 0/2 | 0/1 |
| Non-cardiac chest painGeneral disorders | 0/16 | 1/6 | 0/14 | 0/6 | 0/7 | 0/6 | 0/2 | 0/1 | 0/2 | 0/1 |
| SinusitisInfections and infestations | 0/16 | 1/6 | 0/14 | 0/6 | 0/7 | 0/6 | 0/2 | 0/1 | 0/2 | 0/1 |
| HyponatraemiaMetabolism and nutrition disorders | 0/16 | 0/6 | 0/14 | 1/6 | 0/7 | 0/6 | 0/2 | 0/1 | 0/2 | 0/1 |
| Event | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed | PACT Phase: Part B: TSR-042 and Carboplatin-paclitaxel | PACT Phase: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab |
|---|---|---|---|---|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 4/16 | 3/6 | 10/14 | 2/6 | 5/7 | 5/6 | 2/2 | 1/1 | 0/2 | 0/1 |
| ThrombocytopeniaBlood and lymphatic system disorders | 4/16 | 2/6 | 2/14 | 2/6 | 2/7 | 2/6 | 0/2 | 1/1 | 0/2 | 0/1 |
| TachycardiaCardiac disorders | 2/16 | 0/6 | 2/14 | 0/6 | 1/7 | 0/6 | 0/2 | 1/1 | 0/2 | 0/1 |
| Abdominal pain upperGastrointestinal disorders | 0/16 | 1/6 | 0/14 | 0/6 | 1/7 | 0/6 | 0/2 | 1/1 | 0/2 | 0/1 |
| ConstipationGastrointestinal disorders | 5/16 | 2/6 | 4/14 | 4/6 | 4/7 | 3/6 | 2/2 | 0/1 | 0/2 | 0/1 |
| NauseaGastrointestinal disorders | 8/16 | 4/6 | 4/14 | 3/6 | 4/7 | 3/6 | 2/2 | 0/1 | 0/2 | 0/1 |
| FatigueGeneral disorders | 4/16 | 3/6 | 7/14 | 2/6 | 4/7 | 4/6 | 1/2 | 1/1 | 0/2 | 0/1 |
| PainGeneral disorders | 1/16 | 1/6 | 1/14 | 0/6 | 0/7 | 1/6 | 0/2 | 1/1 | 0/2 | 0/1 |
| Urinary tract infectionInfections and infestations | 1/16 | 0/6 | 4/14 | 1/6 | 0/7 | 2/6 | 0/2 | 1/1 | 0/2 | 0/1 |
| Neutrophil count decreasedInvestigations | 0/16 | 0/6 | 0/14 | 0/6 | 1/7 | 0/6 | 1/2 | 1/1 | 0/2 | 0/1 |
Parts G, H and I were not initiated due to business strategic reason. Hence, no participants were enrolled in Parts G, H and I.
| Age, Customized(Participants) | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed | Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel | Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel | Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 18-64 years | 8 | 3 | 5 | 4 | 6 | 2 | 1 | 1 | 0 | 0 | 0 | 30 |
| 65-74 years | 6 | 1 | 4 | 2 | 1 | 3 | 0 | 0 | 0 | 0 | 0 | 17 |
| >=75 years | 2 | 2 | 5 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 11 |
| Sex: Female, Male(Participants) | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed | Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel | Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel | Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 9 | 2 | 8 | 4 | 7 | 5 | 0 | NA | 0 | 0 | 0 | NA |
| Male | 7 | 4 | 6 | 2 | 0 | 1 | 2 | NA | 0 | 0 | 0 | NA |
| Race/Ethnicity, Customized(Participants) | Main Study: Part A: TSR-042 and Niraparib 200 mg QD | Main Study: Part A: TSR-042 and Niraparib 300 mg QD | Main Study: Part B: TSR-042 and Carboplatin-paclitaxel | Main Study: Part C: TSR-042, Niraparib 200 mg QD and Bevacizumab | Main Study: Part C: TSR-042, Niraparib 300 mg QD and Bevacizumab | Main Study: Part D: TSR-042, Carboplatin-paclitaxel and Bevacizumab | Main Study: Part E: TSR-042 and Carboplatin-pemetrexed | Main Study: Part F: TSR-042, TSR-022, and Carboplatin-pemetrexed | Main Study: Part G: TSR-042 and Carboplatin-nab-paclitaxel | Main Study: Part H: TSR-042, TSR-022, and Carboplatin-nab-paclitaxel | Main Study: Part I: TSR-042, TSR-022, and Carboplatin-paclitaxel | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Black or African American | 0 | 1 | 1 | 0 | 2 | 0 | 1 | NA | 0 | 0 | 0 | NA |
| White | 16 | 5 | 13 | 6 | 5 | 6 | 1 | NA | 0 | 0 | 0 | NA |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Feb 2020, 28 months.
Results were first posted in May 2021, 1 year 2 months after primary completion.
Of 473 industry-sponsored phase 1 interventional studies under Carcinoma, Non-Small-Cell Lung, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 66. This study's 28 months is below that.
Counting every sponsor, half of 699 studies reached it within 50 months; a quarter within 31 and three quarters within 70.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Dostarlimab · Cobolimab
Carcinoma, Non-Small-Cell Lung →