A Phase 1 interventional study of Niraparib in Ovarian Neoplasms, Neoplasms and Solid Tumor, sponsored by Tesaro, Inc.. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-28.
Sponsored by Tesaro, Inc. (part of GlaxoSmithKline) · Phase 1, Interventional, and Treatment
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Among 44 studies testing niraparib in Ovarian Neoplasms — 9 open to participants now, 14 under way, 2 of them phase 3. niraparib · Ovarian Neoplasms.
Among the 44 studies testing niraparib in Ovarian Neoplasms, this one is the 36th largest by enrollment, is one of 5 that started in 2018, is one of 10 in phase 1, and was the 10th registered.
3,385 studies on the registry are indexed under Ovarian Neoplasms; 792 are open to participants now.
Browse Ovarian Neoplasms studies →9 of the 44 studies testing niraparib in Ovarian Neoplasms are open now, in 10 countries. Recruiting first, the newest first:
University of Miami · Sites in United States, Nigeria
Ages 18+ · Women only
MedSIR · Sites in Spain
Ages 18+ · Women only
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Sites in Italy
Ages 18+ · Women only
Institute of Cancer Research, United Kingdom · Sites in United Kingdom
Ages 18+ · Women only
Sunnybrook Health Sciences Centre · Sites in Canada
Ages 18+ · Women only
By country, each count listing its studies:
niraparib: first FDA approval 2017 (ZEJULA), first EMA approval 2017. What it is approved for, and how studies give it, is on its page →
Of the 605 Ovarian Neoplasms studies recruiting now, 442 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 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.
On this site’s reading of the record, niraparib is the treatment under test here. Read study by study →
44 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 14 · Phase 2 22 · Phase 3 7 · Phase 4 5
First in 2008; this study’s year is marked. 5 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 17 is below the median of 54 across 2,552 interventional studies indexed under Ovarian Neoplasms.
Median enrollment 41 across the 44 interventional studies. Of the 21 that completed or were terminated, 10 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
21 of 44 have an industry lead sponsor. The 10 most frequent:
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.
31 studies in Ovarian Neoplasms by GlaxoSmithKline: 5 open now, 7 under way, 5 of them phase 3. Of 22 finished, 16 (73%) have results posted.
Among the 31 studies in Ovarian Neoplasms by GlaxoSmithKline, this one is the 27th largest by enrollment of the 30 interventional ones that give a count, is one of 4 that started in 2018, is one of 6 in phase 1, and was the 20th registered.
GlaxoSmithKline’s Ovarian Neoplasms studies by the year they started, since 1997.
2 of the studies testing niraparib in Ovarian Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04641247GlaxoSmithKlineA Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study | 2026-12-28 |
| NCT06594679Fondazione IRCCS Istituto Nazionale dei Tumori, MilanoA Study of Niraparib in Combination With Abemaciclib for Late Line Treatment of Ovarian Cancer (NICHOL TRIAL) | 2027-03-20 |
Add all 2 to your calendar (.ics) → With an account.
Among the 44 studies testing niraparib in Ovarian Neoplasms, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among GlaxoSmithKline’s 31 in Ovarian Neoplasms:
This tab as a report to print or save as PDF → With an account.
Niraparib (Zejula®)is extensively metabolized and eliminated primarily by hepatic and renal pathways. The purpose of this study is to evaluate pharmacokinetics and safety of niraparib in patients with moderate hepatic impairment, for the purpose of providing recommendations to guide the initial dose and dose titration in this patient population.
Inclusion Criteria:
Diagnosis and Criteria for Inclusion:
All patients:
To be considered eligible to participate in this study, all of the following requirements must be met:
Female patient, if of , has a negative serum pregnancy test within 72 hours prior to taking study drug and agrees to abstain from activities that could result in pregnancy from enrollment through 120 days after the last dose of study treatment, or be of non-childbearing potential. Non-childbearing potential is defined as (by other than medical reasons):
Note: Abstinence is acceptable if this is the established and preferred for the patient.
Patients with normal hepatic function (Group 1):
Patients screened for the normal hepatic function group must meet the following additional criteria to be eligible for enrollment:
Patient has liver function test (LFT) results within normal range:
Patient has adequate hematologic and renal function as defined below:
Patients with moderate hepatic impairment (Group 2):
Patients screened for the moderate hepatic impairment group must meet the following additional criteria to be eligible for enrollment:
Patient has stable, moderate hepatic impairment, defined as:
Patient has hematologic and renal function as defined below:
Criteria for Exclusion:
Patients will not be eligible for study entry if any of the following criteria are met:
All patients:
Patient has a known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
NOTE: Exclusion Criteria 12-16 apply patients participating in the PK phase of the study.
Patients with moderate hepatic impairment (Group 2):
Patients screened for the moderate hepatic impairment group who meet any of the following additional criteria will be excluded from the study:
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.
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.
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
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.
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.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (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.
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.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
To evaluate the pharmocokinetics and safety of niraparib
Drug: Niraparib
To evaluate the pharmocokinetics and safety of niraparib
Drug: Niraparib
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®
Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Niraparib and Its Major Metabolite (M1) During PK Phase
Blood samples were collected at indicated time points to evaluate AUC (last) of niraparib and M1. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose Day 1
Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC 0-infinity) of Niraparib and M1 During PK Phase
Blood samples were collected at indicated time points to evaluate AUC (0-infinity) of niraparib and M1. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose Day 1
Observed Maximum Plasma Concentration (Cmax) of Niraparib and M1 During PK Phase
Blood samples were collected at indicated time points to evaluate Cmax of niraparib and M1. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose Day 1
Time to Maximum Concentration (Tmax) of Niraparib and M1 During PK Phase
Blood samples were collected at indicated time points to evaluate tmax of niraparib and M1. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose Day 1
Terminal Half-life (t½) of Niraparib and M1 During PK Phase
Blood samples were collected at indicated time points to evaluate t1/2 of niraparib and M1. PK parameters were calculated by standard non-compartmental analysis.
Time frame: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose Day 1
Apparent Total Body Clearance (CL/F) of Niraparib and M1 During PK Phase
CL/F is calculated as Dose/(AUC 0-inf). Blood samples were collected at indicated time points to evaluate CL/F of niraparib and M1. PK parameters were calculated by standard non-compartmental analysis. Not applicable (NA) indicates that CL/F could not be measured for M1 since the dose of metabolite is unknown and only known dose is that of parent niraparib.
Time frame: Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose Day 1
Number of Participants With Treatment-Emergent Adverse Events (TEAE) Including Non-serious Adverse Events (Non-SAEs), Serious Adverse Events (SAEs) and Discontinuations Due to AEs During PK Phase
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. 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 disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event(s) requiring medical or scientific judgment. Treatment-emergent are 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 Day 8
Change From Baseline in Hemoglobin (Hb) During PK Phase
Blood samples were collected from participants for evaluation of Hb. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Time frame: Baseline and at Day 8
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocyte During PK Phase
Blood samples were collected to analyze hematology parameters:Leukocyte, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Time frame: Baseline and Day 8
Change From Baseline in Clinical Chemistry Parameter of Protein and Albumin During PK Phase
Blood samples were collected to analyze clinical chemistry parameters: protein and albumin. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Time frame: Baseline and Day 8
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Lactate Dehydrogenase (LDH) During PK Phase
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters: alkaline phosphatase, ALT, AST and LDH. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Time frame: Baseline and Day 8
Change From Baseline in Clinical Chemistry Parameter of Amylase During PK Phase
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter: Amylase. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Time frame: Baseline and Day 8
Change From Baseline in Clinical Chemistry Parameter of Bilirubin and Creatinine During PK Phase
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters: Bilirubin and Creatinine. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Time frame: Baseline and Day 8
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and Blood Urea Nitrogen (BUN) During PK Phase
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter:Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Time frame: Baseline and Day 8
Change From Baseline in Weight During PK Phase
Weight was measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Time frame: Baseline, Day 2 and Day 8
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) During PK Phase
Vital signs including SBP and DBP were measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Time frame: Baseline, Day 2 and Day 8
Change From Baseline in Pulse Rate During PK Phase
Vital sign including pulse rate was measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Time frame: Baseline, Day 2 and Day 8
Change From Baseline in Body Temperature During PK Phase
Vital sign including body temperature was measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
Time frame: Baseline, Day 2 and Day 8
Number of Participants With TEAE Including Non-SAEs, SAEs and Discontinuations Due to AEs During Extension Phase
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. 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 disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event(s) requiring medical or scientific judgment. Treatment-emergent are 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 28 months
Change From Baseline in Hb During Extension Phase
Blood samples were collected from participants for evaluation of Hb. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Time frame: Baseline and Cycle 1 (Days 8, 15, 21), Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, and Cycle 6 Day 1 (each cycle was of 28 days)
Change From Baseline in Platelets, Neutrophils, Monocytes, Lymphocytes and Leukocytes During Extension Phase
Blood samples were collected to analyze hematology parameters: Lymphocytes, Leukocytes, Monocytes, Neutrophils and Platelets. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Time frame: Baseline and Cycle 1 (Days 8, 15, 21), Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, and Cycle 6 Day 1 (each cycle was of 28 days)
Change From Baseline in Clinical Chemistry Parameter of Protein and Albumin During Extension Phase
Blood samples were collected to analyze clinical chemistry parameters: protein and albumin. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Time frame: Baseline and Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1 (each cycle was of 28 days)
Change From Baseline in Clinical Chemistry Parameter of Alkaline Phosphatase, ALT, AST and LDH During Extension Phase
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters: alkaline phosphatase, ALT, AST and LDH. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Time frame: Baseline and Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1 (each cycle was of 28 days)
Change From Baseline in Clinical Chemistry Parameter of Amylase During Extension Phase
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter: Amylase. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Time frame: Baseline and Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1 (each cycle was of 28 days)
Change From Baseline in Clinical Chemistry Parameter of Bilirubin and Creatinine During Extension Phase
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter: Bilirubin and Creatinine. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Time frame: Baseline and Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1 (each cycle was of 28 days)
Change From Baseline in Chemistry Parameters: Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN During Extension Phase
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter:Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Time frame: Baseline and Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1 (each cycle was of 28 days)
Change From Baseline in Weight During Extension Phase
Weight was measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Time frame: Baseline and Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1 (each cycle was of 28 days)
Change From Baseline in SBP and DBP During Extension Phase
Vital signs including SBP and DBP were measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Time frame: Baseline and Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1 (each cycle was of 28 days)
Change From Baseline in Pulse Rate During Extension Phase
Vital sign including pulse rate was measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Time frame: Baseline and Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1 (each cycle was of 28 days)
Change From Baseline in Temperature During Extension Phase
Vital sign including temperature was measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
Time frame: Baseline and Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 and Cycle 6 Day 1 (each cycle was of 28 days)
Plasma Protein Unbound Fraction (Fu) of Niraparib and M1 During PK Phase
Unbound fraction is the unbound concentration of niraparib and M1 in plasma divided by total concentration. This analysis was planned but not performed due to insufficient participants with data
Time frame: Pre-dose, 3 hours and 168 hours post dose Day 1
Clearance of Unbound Niraparib and M1 (CLfu/F) During PK Phase
CLfu/F is the clearance for unbound niraparib and M1. This analysis was planned but not performed due to insufficient participants with data
Time frame: Pre-dose, 3 hours and 168 hours post dose Day 1
This study evaluated pharmacokinetics and safety of niraparib in participants with advanced solid tumors and with either normal hepatic function or moderate hepatic impairment.
| Milestone | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Started | 9 | 8 |
| Completed | 8 | 7 |
| Not completed | 1 | 1 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Adverse event | 1 | 0 |
| Milestone | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Started | 8 | 7 |
| Completed | 0 | 1 |
| Not completed | 8 | 6 |
| Withdrew: Death | 2 | 4 |
| Withdrew: Withdrawal by subject | 1 | 2 |
| Withdrew: Disease progression | 5 | 0 |
Blood samples were collected at indicated time points to evaluate AUC (last) of niraparib and M1. PK parameters were calculated by standard non-compartmental analysis.
| Hour*nanogram per milliliter (hr*ng/mL) | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Niraparib | 18500 ± 37.7 | 26800 ± 49.6 |
| M1 | 19000 ± 27.5 | 12400 ± 55.0 |
Blood samples were collected at indicated time points to evaluate AUC (0-infinity) of niraparib and M1. PK parameters were calculated by standard non-compartmental analysis.
| Hour*nanogram per milliliter (hr*ng/mL) | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Niraparib, n= 9, 7 | 19700 ± 38.7 | 30800 ± 54.3 |
| M1, n=9, 3 | 20700 ± 29.8 | 21500 ± 25.4 |
Blood samples were collected at indicated time points to evaluate Cmax of niraparib and M1. PK parameters were calculated by standard non-compartmental analysis.
| Nanogram per milliliter | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Niraparib | 594 ± 45.6 | 553 ± 47.4 |
| M1 | 398 ± 17.6 | 151 ± 89.3 |
Blood samples were collected at indicated time points to evaluate tmax of niraparib and M1. PK parameters were calculated by standard non-compartmental analysis.
| Hour | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Niraparib | 4.00 (3.00 to 6.33) | 4.09 (2.00 to 8.02) |
| M1 | 6.00 (4.00 to 12.08) | 17.73 (6.00 to 25.17) |
Blood samples were collected at indicated time points to evaluate t1/2 of niraparib and M1. PK parameters were calculated by standard non-compartmental analysis.
| Hour | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Niraparib, n=9, 7 | 43.9 ± 11.5 | 54.8 ± 25.8 |
| M1, n=9, 3 | 47.9 ± 16.6 | 43.7 ± 20.7 |
CL/F is calculated as Dose/(AUC 0-inf). Blood samples were collected at indicated time points to evaluate CL/F of niraparib and M1. PK parameters were calculated by standard non-compartmental analysis. Not applicable (NA) indicates that CL/F could not be measured for M1 since the dose of metabolite is unknown and only known dose is that of parent niraparib.
| Liters per hour | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Niraparib | 15.2 ± 38.7 | 9.74 ± 54.3 |
| M1 | NA ± NA | NA ± NA |
Unbound fraction is the unbound concentration of niraparib and M1 in plasma divided by total concentration. This analysis was planned but not performed due to insufficient participants with data
No measurements were reported for this outcome.
CLfu/F is the clearance for unbound niraparib and M1. This analysis was planned but not performed due to insufficient participants with data
No measurements were reported for this outcome.
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. 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 disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event(s) requiring medical or scientific judgment. Treatment-emergent are 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.
| Participants | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Any Non -SAEs | 5 | 3 |
| Any SAE | 1 | 0 |
| Any Discontinuations due to AE | 1 | 0 |
Blood samples were collected from participants for evaluation of Hb. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
| Grams per liter | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Change From Baseline in Hemoglobin (Hb) During PK Phase | -0.5 ± 7.82 | 0.6 ± 7.65 |
Blood samples were collected to analyze hematology parameters:Leukocyte, Lymphocytes, Monocytes, Neutrophils and Platelets. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
| 10^9 cells per liter | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Lymphocytes | 0.2 ± 0.38 | -0.1 ± 0.15 |
| Monocytes | 0.1 ± 0.32 | -0.1 ± 0.24 |
| Neutrophils | -0.5 ± 2.13 | -0.7 ± 1.89 |
| Platelets | -18.4 ± 95.41 | -23.4 ± 60.31 |
| Leukocyte | -0.2 ± 2.04 | -0.8 ± 2.16 |
Blood samples were collected to analyze clinical chemistry parameters: protein and albumin. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
| Grams per liter | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Protein | -1.0 ± 4.24 | -3.5 ± 5.55 |
| Albumin | -0.9 ± 2.03 | -2.3 ± 3.45 |
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters: alkaline phosphatase, ALT, AST and LDH. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
| International units per Liter | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Alkaline phosphatase | 26.3 ± 50.67 | -32.6 ± 219.03 |
| AST | 34.6 ± 94.42 | -6.4 ± 43.81 |
| ALT | 24.3 ± 60.82 | -4.4 ± 10.39 |
| LDH | 36.0 ± 134.66 | -58.5 ± 137.97 |
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter: Amylase. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
| Units per Liter | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Change From Baseline in Clinical Chemistry Parameter of Amylase During PK Phase | 74.4 ± 206.90 | 0.3 ± 22.92 |
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters: Bilirubin and Creatinine. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
| Micromoles per liter | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Bilirubin | 0.6 ± 3.41 | 8.3 ± 9.47 |
| Creatinine | -1.9 ± 10.87 | -0.7 ± 17.19 |
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter:Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
| Millimoles per liter | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Glucose, n=8, 8 | -0.8 ± 1.14 | -0.5 ± 1.61 |
| Calcium, n=8, 8 | 0.0 ± 0.17 | -0.1 ± 0.15 |
| Chloride, n=8, 8 | 1.8 ± 2.25 | -0.3 ± 1.83 |
| Phosphate, n=8, 8 | 0.1 ± 0.16 | -0.1 ± 0.14 |
| Potassium, n=8, 8 | -0.2 ± 0.26 | -0.2 ± 0.74 |
| Sodium, n=8, 8 | 1.6 ± 2.26 | -0.5 ± 2.78 |
| BUN, n=8, 8 | -0.4 ± 1.66 | -0.1 ± 0.97 |
| Magnesium, n=8, 7 | -0.0 ± 0.09 | 0.0 ± 0.09 |
Weight was measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
| Kilograms | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Day 2, n=8, 6 | -0.0 ± 0.58 | 0.8 ± 0.87 |
| Day 8, n=9, 8 | -0.0 ± 1.14 | 0.3 ± 1.30 |
Vital signs including SBP and DBP were measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
| Millimeters of mercury | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| SBP, Day 2, n=9, 7 | 5.9 ± 10.79 | 5.7 ± 10.23 |
| SBP, Day 8, n=9, 8 | 0.9 ± 18.58 | 0.3 ± 9.69 |
| DBP, Day 2, n=9, 7 | 3.6 ± 8.38 | 2.7 ± 3.15 |
| DBP, Day 8, n=9, 8 | 2.4 ± 9.08 | -0.1 ± 11.18 |
Vital sign including pulse rate was measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
| Beats per minute | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Day 2, n=9, 7 | 8.9 ± 11.30 | 1.3 ± 10.58 |
| Day 8, n=9, 8 | 2.8 ± 11.91 | -2.3 ± 7.85 |
Vital sign including body temperature was measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in PK phase. Change from Baseline was calculated as post dose value minus Baseline value.
| Degrees Celsius | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Day 2, n=9, 7 | -0.0 ± 0.39 | 0.1 ± 0.24 |
| Day 8, n=9, 8 | 0.1 ± 0.33 | 0.1 ± 0.47 |
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. 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 disability/incapacity; is a congenital anomaly/birth defect; or is an important medical event(s) requiring medical or scientific judgment. Treatment-emergent are 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.
| Participants | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Any Non-SAEs | 8 | 7 |
| Any SAE | 3 | 2 |
| Any Discontinuations due to AE | 0 | 1 |
Blood samples were collected from participants for evaluation of Hb. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
| Grams per liter | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Cycle 1 Day 8, n=8, 5 | 4.3 ± 5.78 | 1.0 ± 8.89 |
| Cycle 1 Day 15, n=8, 4 | -0.5 ± 6.32 | -8.3 ± 15.73 |
| Cycle 1 Day 21, n=7, 4 | -2.6 ± 12.91 | -22.3 ± 17.19 |
| Cycle 2 Day 1, n=6, 2 | -8.0 ± 14.93 | -15.0 ± 1.41 |
| Cycle 3 Day 1, n=3, 1 | -16.7 ± 12.10 | -10.0 ± NA |
| Cycle 4 Day 1, n=3, 0 | -10.7 ± 11.06 | — |
| Cycle 5 Day 1, n=3, 0 | -3.7 ± 2.08 | — |
| Cycle 6 Day1, n=2, 0 | 3.0 ± 7.07 | — |
Blood samples were collected to analyze hematology parameters: Lymphocytes, Leukocytes, Monocytes, Neutrophils and Platelets. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
| 10^9 cells per liter | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Lymphocytes, Cycle 1 Day 8, n=7, 5 | -0.2 ± 0.36 | -0.1 ± 0.22 |
| Lymphocytes, Cycle 1 Day 15, n=8, 4 | -0.1 ± 0.37 | -0.0 ± 0.48 |
| Lymphocytes, Cycle 1 Day 21, n=7, 4 | -0.1 ± 0.25 | -0.2 ± 0.20 |
| Lymphocytes, Cycle 2 Day 1, n=6, 2 | -0.1 ± 0.33 | 0.1 ± 0.04 |
| Lymphocytes, Cycle 3 Day 1, n=3, 1 | -0.3 ± 0.24 | 0.2 ± NA |
| Lymphocytes, Cycle 4 Day 1, n=3, 0 | 0.0 ± 0.33 | — |
| Lymphocytes, Cycle 5 Day 1, n=3, 0 | 0.3 ± 0.30 | — |
| Lymphocytes, Cycle 6 Day1, n=2, 0 | -0.0 ± 0.54 | — |
| Monocytes, Cycle 1 Day 8, n=7, 5 | -0.1 ± 0.20 | 0.0 ± 0.11 |
| Monocytes, Cycle 1 Day 15, n=8, 4 | -0.2 ± 0.28 | -0.1 ± 0.22 |
| Monocytes, Cycle 1 Day 21, n=7, 4 | -0.2 ± 0.20 | -0.1 ± 0.40 |
| Monocytes, Cycle 2 Day 1, n=6, 2 | -0.1 ± 0.14 | -0.1 ± 0.16 |
| Monocytes, Cycle 3 Day 1, n=3, 1 | -0.2 ± 0.06 | 0.0 ± NA |
| Monocytes, Cycle 4 Day 1, n=3, 0 | -0.0 ± 0.09 | — |
| Monocytes, Cycle 5 Day 1, n=3, 0 | -0.1 ± 0.10 | — |
| Monocytes, Cycle 6 Day1, n=2, 0 | -0.1 ± 0.16 | — |
| Neutrophils, Cycle 1 Day 8, n=7, 5 | 0.4 ± 0.87 | 0.4 ± 0.44 |
| Neutrophils, Cycle 1 Day 15, n=8, 4 | 0.3 ± 1.01 | 0.5 ± 0.73 |
| Neutrophils, Cycle 1 Day 21, n=7, 4 | -0.6 ± 1.92 | -0.2 ± 0.81 |
| Neutrophils, Cycle 2 Day 1, n=6, 2 | 0.6 ± 2.03 | -1.8 ± 1.94 |
| Neutrophils, Cycle 3 Day 1, n=3, 1 | -0.0 ± 1.70 | -0.5 ± NA |
| Neutrophils, Cycle 4 Day 1, n=3, 0 | -0.4 ± 0.51 | — |
| Neutrophils, Cycle 5 Day 1, n=3, 0 | 0.5 ± 0.27 | — |
| Neutrophils, Cycle 6 Day1, n=2, 0 | -0.1 ± 0.78 | — |
| Platelets, Cycle 1 Day 8, n=8, 5 | 12.0 ± 21.75 | -0.8 ± 21.32 |
| Platelets, Cycle 1 Day 15, n=8, 4 | -58.1 ± 118.98 | -8.3 ± 63.33 |
| Platelets, Cycle 1 Day 21, n=7, 4 | -81.9 ± 113.91 | -19.3 ± 57.70 |
| Platelets, Cycle 2 Day 1, n=6, 2 | 55.3 ± 128.24 | -102.5 ± 130.81 |
| Platelets, Cycle 3 Day 1, n=3, 1 | -46.3 ± 36.46 | 59.0 ± NA |
| Platelets, Cycle 4 Day 1, n=3, 0 | 34.0 ± 43.92 | — |
| Platelets, Cycle 5 Day 1, n=3, 0 | 45.7 ± 22.68 | — |
| Platelets, Cycle 6 Day1, n=2, 0 | 34.0 ± 42.43 | — |
| Leukocytes, Cycle 1 Day 8, n=8, 5 | 0.4 ± 1.76 | 0.3 ± 0.40 |
| Leukocytes, Cycle 1 Day 15, n=8, 4 | -0.1 ± 1.25 | 0.4 ± 1.28 |
| Leukocytes, Cycle 1 Day 21, n=7, 4 | -1.0 ± 2.05 | -0.5 ± 1.36 |
| Leukocytes, Cycle 2 Day 1, n=6, 2 | 0.5 ± 1.96 | -1.9 ± 1.91 |
| Leukocytes, Cycle 3 Day 1, n=3, 1 | -0.5 ± 1.67 | -0.2 ± NA |
| Leukocytes, Cycle 4 Day 1, n=3, 0 | -0.4 ± 0.76 | — |
| Leukocytes, Cycle 5 Day 1, n=3, 0 | 0.9 ± 0.31 | — |
| Leukocytes, Cycle 6 Day1, n=2, 0 | -0.3 ± 1.48 | — |
Blood samples were collected to analyze clinical chemistry parameters: protein and albumin. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
| Grams per liter | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Protein, Cycle 2 Day 1, n=6, 2 | -1.0 ± 6.96 | -2.0 ± 0.00 |
| Protein, Cycle 3 Day 1, n=3, 1 | -2.0 ± 3.46 | -5.0 ± NA |
| Protein, Cycle 4 Day 1, n=3, 0 | 1.0 ± 3.61 | — |
| Protein, Cycle 5 Day 1, n=3, 0 | 4.0 ± 2.65 | — |
| Protein, Cycle 6 Day1, n=2, 0 | 0.0 ± 2.83 | — |
| Albumin, Cycle 2 Day 1, n=6, 2 | 0.3 ± 4.37 | -1.0 ± 0.00 |
| Albumin, Cycle 3 Day 1, n=3, 1 | 1.0 ± 2.65 | -1.0 ± NA |
| Albumin, Cycle 4 Day 1, n=3, 0 | 2.7 ± 3.21 | — |
| Albumin, Cycle 5 Day 1, n=3, 0 | 4.7 ± 2.52 | — |
| Albumin, Cycle 6 Day1, n=2, 0 | 17.0 ± 16.97 | — |
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameters: alkaline phosphatase, ALT, AST and LDH. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
| International units per Liter | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Alkaline Phosphatase, Cycle 2 Day 1, n=6, 2 | 23.3 ± 17.43 | -53.5 ± 221.32 |
| Alkaline Phosphatase, Cycle 3 Day 1, n=3, 1 | 19.7 ± 5.03 | 57.0 ± NA |
| Alkaline Phosphatase, Cycle 4 Day 1, n=3, 0 | 20.0 ± 10.54 | — |
| Alkaline Phosphatase, Cycle 5 Day 1, n=3, 0 | 12.0 ± 14.80 | — |
| Alkaline Phosphatase, Cycle 6 Day1, n=2, 0 | 1.5 ± 16.26 | — |
| ALT, Cycle 2 Day 1, n=6, 2 | 11.8 ± 19.77 | -6.5 ± 20.51 |
| ALT, Cycle 3 Day 1, n=3, 1 | 4.7 ± 6.11 | 4.0 ± NA |
| ALT, Cycle 4 Day 1, n=3, 0 | 2.0 ± 5.00 | — |
| ALT, Cycle 5 Day 1, n=3, 0 | 5.3 ± 7.02 | — |
| ALT, Cycle 6 Day1, n=2, 0 | 2.0 ± 4.24 | — |
| AST, Cycle 2 Day 1, n=6, 2 | 4.8 ± 5.81 | -25.0 ± 38.18 |
| AST, Cycle 3 Day 1, n=3, 1 | 2.0 ± 2.65 | 4.0 ± NA |
| AST, Cycle 4 Day 1, n=3, 0 | 4.3 ± 2.31 | — |
| AST, Cycle 5 Day 1, n=3, 0 | 5.3 ± 2.52 | — |
| AST, Cycle 6 Day1, n=2, 0 | 5.5 ± 4.95 | — |
| LDH, Cycle 2 Day 1, n=3, 2 | 11.7 ± 37.53 | -625.0 ± 847.11 |
| LDH, Cycle 3 Day 1, n=3, 1 | 6.7 ± 17.56 | -9.0 ± NA |
| LDH, Cycle 4 Day 1, n=3, 0 | -11.7 ± 41.77 | — |
| LDH, Cycle 5 Day 1, n=3, 0 | -5.3 ± 21.46 | — |
| LDH, Cycle 6 Day1, n=2, 0 | 19.0 ± 35.36 | — |
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter: Amylase. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
| Units per Liter | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Cycle 2 Day 1, n=4, 2 | -1.0 ± 16.39 | -2.5 ± 6.36 |
| Cycle 3 Day 1, n=3, 1 | -7.0 ± 14.18 | -4.0 ± NA |
| Cycle 4 Day 1, n=3, 0 | -2.3 ± 16.77 | — |
| Cycle 5 Day 1, n=3, 0 | 3.0 ± 5.57 | — |
| Cycle 6 Day1, n=2, 0 | -2.5 ± 31.82 | — |
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter: Bilirubin and Creatinine. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
| Micromoles per liter | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Bilirubin, Cycle 2 Day 1, n=6, 2 | 0.9 ± 1.79 | -6.0 ± 8.46 |
| Bilirubin, Cycle 3 Day 1, n=3, 1 | 0.6 ± 2.61 | 1.7 ± NA |
| Bilirubin, Cycle 4 Day 1, n=3, 0 | 0.6 ± 0.99 | — |
| Bilirubin, Cycle 5 Day 1, n=3, 0 | 2.9 ± 0.99 | — |
| Bilirubin, Cycle 6 Day1, n=2, 0 | -0.9 ± 1.21 | — |
| Creatinine, Cycle 2 Day 1, n=6, 2 | 7.5 ± 17.93 | 18.1 ± 3.13 |
| Creatinine, Cycle 3 Day 1, n=3, 1 | 13.0 ± 5.03 | 0.0 ± NA |
| Creatinine, Cycle 4 Day 1, n=3, 0 | 0.9 ± 9.56 | — |
| Creatinine, Cycle 5 Day 1, n=3, 0 | 5.6 ± 2.84 | — |
| Creatinine, Cycle 6 Day1, n=2, 0 | 5.7 ± 5.63 | — |
Blood samples were collected at indicated time-points for analysis of clinical chemistry parameter:Glucose, Calcium, Chloride, Phosphate, Potassium, Sodium, Magnesium and BUN. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
| Millimoles per liter | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Glucose, Cycle 2 Day 1, n=6, 2 | -0.0 ± 1.45 | 1.6 ± 0.47 |
| Glucose, Cycle 3 Day 1, n=3, 1 | 0.7 ± 1.50 | -2.3 ± NA |
| Glucose, Cycle 4 Day 1, n=3, 0 | -0.4 ± 0.95 | — |
| Glucose, Cycle 5 Day 1, n=3, 0 | -0.7 ± 0.90 | — |
| Glucose, Cycle 6 Day1, n=2, 0 | -0.8 ± 0.90 | — |
| Calcium, Cycle 2 Day 1, n=6, 2 | -0.0 ± 0.16 | 0.0 ± 0.14 |
| Calcium, Cycle 3 Day 1, n=3, 1 | 0.0 ± 0.06 | 0.0 ± NA |
| Calcium, Cycle 4 Day 1, n=3, 0 | 0.0 ± 0.00 | — |
| Calcium, Cycle 5 Day 1, n=3, 0 | 0.1 ± 0.10 | — |
| Calcium, Cycle 6 Day1, n=2, 0 | -0.0 ± 0.02 | — |
| Chloride, Cycle 2 Day 1, n=6, 2 | -1.7 ± 2.25 | -3.5 ± 2.12 |
| Chloride, Cycle 3 Day 1, n=3, 1 | -2.0 ± 3.61 | 0.0 ± NA |
| Chloride, Cycle 4 Day 1, n=3, 0 | -0.7 ± 1.53 | — |
| Chloride, Cycle 5 Day 1, n=3, 0 | -1.7 ± 1.15 | — |
| Chloride, Cycle 6 Day1, n=2, 0 | -2.5 ± 2.12 | — |
| Phosphate, Cycle 2 Day 1, n=5, 2 | -0.2 ± 0.34 | 0.3 ± 0.02 |
| Phosphate, Cycle 3 Day 1, n=3, 1 | 0.0 ± 0.18 | -0.1 ± NA |
| Phosphate, Cycle 4 Day 1, n=3, 0 | -0.1 ± 0.26 | — |
| Phosphate, Cycle 5 Day 1, n=3, 0 | 0.0 ± 0.43 | — |
| Phosphate, Cycle 6 Day1, n=2, 0 | 0.0 ± 0.30 | — |
| Potassium, Cycle 2 Day 1, n=6, 2 | -0.2 ± 0.12 | 0.1 ± 0.21 |
| Potassium, Cycle 3 Day 1, n=3, 1 | 0.1 ± 0.30 | 0.4 ± NA |
| Potassium, Cycle 4 Day 1, n=3, 0 | 0.0 ± 0.20 | — |
| Potassium, Cycle 5 Day 1, n=3, 0 | 0.1 ± 0.38 | — |
| Potassium, Cycle 6 Day1, n=2, 0 | 0.1 ± 0.21 | — |
| Sodium, Cycle 2 Day 1, n=6, 2 | -1.8 ± 1.17 | -1.5 ± 2.12 |
| Sodium, Cycle 3 Day 1, n=3, 1 | -3.0 ± 1.73 | 1.0 ± NA |
| Sodium, Cycle 4 Day 1, n=3, 0 | -1.0 ± 1.73 | — |
| Sodium, Cycle 5 Day 1, n=3, 0 | -1.7 ± 0.58 | — |
| Sodium, Cycle 6 Day1, n=2, 0 | -1.5 ± 2.12 | — |
| BUN, Cycle 2 Day 1, n=6, 2 | 0.3 ± 2.15 | 1.8 ± 0.50 |
| BUN, Cycle 3 Day 1, n=3, 1 | 0.7 ± 2.14 | 1.4 ± NA |
| BUN, Cycle 4 Day 1, n=3, 0 | -1.0 ± 0.90 | — |
| BUN, Cycle 5 Day 1, n=3, 0 | -0.5 ± 1.25 | — |
| BUN, Cycle 6 Day1, n=2, 0 | -0.5 ± 0.76 | — |
| Magnesium, Cycle 2 Day 1, n=5, 2 | -0.0 ± 0.09 | 0.0 ± 0.00 |
| Magnesium, Cycle 3 Day 1, n=3, 1 | -0.0 ± 0.04 | 0.1 ± NA |
| Magnesium, Cycle 4 Day 1, n=2, 0 | 0.0 ± 0.00 | — |
| Magnesium, Cycle 5 Day 1, n=2, 0 | 0.1 ± 0.00 | — |
| Magnesium, Cycle 6 Day1, n=1, 0 | 0.0 ± NA | — |
Weight was measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
| Kilograms | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Cycle 2 Day 1, n=6, 2 | -1.6 ± 1.74 | -4.6 ± 4.31 |
| Cycle 3 Day 1, n=3, 1 | -0.3 ± 1.00 | -4.5 ± NA |
| Cycle 4 Day 1, n=3, 0 | -2.3 ± 0.85 | — |
| Cycle 5 Day 1, n=3, 0 | -3.3 ± 2.91 | — |
| Cycle 6 Day1, n=2, 0 | -0.4 ± 0.92 | — |
Vital signs including SBP and DBP were measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
| Millimeters of mercury | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| DBP, Cycle 2 Day 1, n=6, 2 | -0.2 ± 3.19 | -12.0 ± 12.73 |
| DBP, Cycle 3 Day 1, n=3, 1 | 8.7 ± 9.81 | -9.0 ± NA |
| DBP, Cycle 4 Day 1, n=3, 0 | -0.3 ± 3.06 | — |
| DBP, Cycle 5 Day 1, n=3, 0 | 12.3 ± 6.51 | — |
| DBP, Cycle 6 Day1, n=2, 0 | 6.5 ± 4.95 | — |
| SBP, Cycle 2 Day 1, n=6, 2 | -1.2 ± 12.89 | -2.5 ± 23.33 |
| SBP, Cycle 3 Day 1, n=3, 1 | 6.7 ± 10.97 | -6.0 ± NA |
| SBP, Cycle 4 Day 1, n=3, 0 | -2.3 ± 7.57 | — |
| SBP, Cycle 5 Day 1, n=3, 0 | 5.7 ± 10.02 | — |
| SBP, Cycle 6 Day1, n=2, 0 | 13.0 ± 1.41 | — |
Vital sign including pulse rate was measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
| Beats per minute | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Cycle 2 Day 1, n=6, 2 | 17.2 ± 10.15 | 9.0 ± 5.66 |
| Cycle 3 Day 1, n=3, 1 | 23.0 ± 20.78 | 4.0 ± NA |
| Cycle 4 Day 1, n=3, 0 | 15.3 ± 8.08 | — |
| Cycle 5 Day 1, n=3, 0 | 9.3 ± 11.55 | — |
| Cycle 6 Day1, n=2, 0 | 16.5 ± 9.19 | — |
Vital sign including temperature was measured at indicated time-points. Baseline is defined as the most recent measurement prior to the first administration of study drug in extension phase. Change from Baseline was calculated as post dose value minus Baseline value. NA indicates standard deviation could not be calculated as a single participant was analyzed.
| Degrees Celsius | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Cycle 2 Day 1, n=6, 2 | -0.3 ± 0.77 | 0.1 ± 0.07 |
| Cycle 3 Day 1, n=3, 1 | -0.1 ± 0.26 | 0.0 ± NA |
| Cycle 4 Day 1, n=3, 0 | -0.0 ± 0.38 | — |
| Cycle 5 Day 1, n=3, 0 | -0.1 ± 0.21 | — |
| Cycle 6 Day1, n=2, 0 | -0.3 ± 0.21 | — |
Collected over All cause mortality, non-SAEs and SAEs were reported from start of study treatment and up to Day 8 in PK Phase and up to 28 months in Extension Phase.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants With Normal Hepatic Function-PK Phase | 0/9 (0%) | 1/9 (11.1%) | 5/9 (55.6%) |
| Participants With Impaired Hepatic Function-PK Phase | 0/8 (0%) | 0/8 (0%) | 3/8 (37.5%) |
| Participants With Normal Hepatic Function-Extension Phase | 2/8 (25%) | 3/8 (37.5%) | 8/8 (100%) |
| Participants With Impaired Hepatic Function-Extension Phase | 4/7 (57.1%) | 2/7 (28.6%) | 7/7 (100%) |
| Event | Participants With Normal Hepatic Function-PK Phase | Participants With Impaired Hepatic Function-PK Phase | Participants With Normal Hepatic Function-Extension Phase | Participants With Impaired Hepatic Function-Extension Phase |
|---|---|---|---|---|
| Abdominal painGastrointestinal disorders | 0/9 | 0/8 | 0/8 | 1/7 |
| SepsisInfections and infestations | 0/9 | 0/8 | 0/8 | 1/7 |
| PyrexiaGeneral disorders | 0/9 | 0/8 | 1/8 | 0/7 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 0/9 | 0/8 | 1/8 | 0/7 |
| Intestinal obstructionGastrointestinal disorders | 0/9 | 0/8 | 1/8 | 0/7 |
| InfluenzaInfections and infestations | 1/9 | 0/8 | 0/8 | 0/7 |
| PneumoniaInfections and infestations | 1/9 | 0/8 | 0/8 | 0/7 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 1/9 | 0/8 | 0/8 | 0/7 |
| Pulmonary hypertensionRespiratory, thoracic and mediastinal disorders | 1/9 | 0/8 | 0/8 | 0/7 |
| Event | Participants With Normal Hepatic Function-PK Phase | Participants With Impaired Hepatic Function-PK Phase | Participants With Normal Hepatic Function-Extension Phase | Participants With Impaired Hepatic Function-Extension Phase |
|---|---|---|---|---|
| FatigueGeneral disorders | 0/9 | 1/8 | 7/8 | 5/7 |
| AnaemiaBlood and lymphatic system disorders | 0/9 | 0/8 | 3/8 | 5/7 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/9 | 0/8 | 2/8 | 5/7 |
| NauseaGastrointestinal disorders | 1/9 | 1/8 | 4/8 | 1/7 |
| ConstipationGastrointestinal disorders | 0/9 | 0/8 | 4/8 | 3/7 |
| Decreased appetiteMetabolism and nutrition disorders | 0/9 | 1/8 | 2/8 | 3/7 |
| Abdominal painGastrointestinal disorders | 0/9 | 0/8 | 2/8 | 3/7 |
| InsomniaPsychiatric disorders | 0/9 | 0/8 | 3/8 | 0/7 |
| Aspartate aminotransferase increasedInvestigations | 1/9 | 1/8 | 0/8 | 2/7 |
| HyperbilirubinaemiaHepatobiliary disorders | 0/9 | 2/8 | 0/8 | 2/7 |
| Age, Continuous(Years) | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function | Total |
|---|---|---|---|
| Mean | 64.8 ± 6.69 | 63.6 ± 7.71 | 64.2 ± 6.98 |
| Sex: Female, Male(Participants) | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function | Total |
|---|---|---|---|
| Female | 2 | 4 | 6 |
| Male | 7 | 4 | 11 |
| Race/Ethnicity, Customized(Participants) | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function | Total |
|---|---|---|---|
| Black or African American | 1 | 0 | 1 |
| White | 8 | 8 | 16 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2018 to primary completion in Sep 2019, 18 months.
Results were first posted in Nov 2020, 1 year 2 months after primary completion.
Of 210 industry-sponsored phase 1 interventional studies under Ovarian Neoplasms, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 65. This study's 18 months is below that.
Counting every sponsor, half of 380 studies reached it within 50 months; a quarter within 32 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Niraparib