A Phase 1 interventional study of Niraparib Tablet and Niraparib Capsule in Neoplasms, sponsored by Tesaro, Inc.. Completed at 16 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-25.
Sponsored by Tesaro, Inc. (part of GlaxoSmithKline) · Phase 1, Interventional, and Treatment
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This is a three stage, open label, randomized-sequence, single-crossover Phase 1 study to evaluate the relative bioavailability (BA) and Bioequivalence (BE) of niraparib administered as a tablet formulation compared to the reference capsule formulation currently marketed in the United States. Stage 3 evaluates the effect of a high-fat meal on niraparib pharmacokinetics (PK) following a single dose of the tablet. The Extension Phase of this study is to enable participants enrolled in the study to continue to receive treatment with niraparib tablets if they are tolerating it and, in the Investigator's opinion, may receive benefit.
10,824 studies on the registry are indexed under Neoplasms; 2,325 are open to participants now.
This study's enrollment of 236 is above the median of 60 across 7,706 interventional studies indexed under Neoplasms.
Browse Neoplasms 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.
Counted across the registry records on this site, refreshed daily.
Key inclusion criteria:
PK Phase: To be considered eligible to participate in this study, all of the following requirements must be met:
Extension Phase:
Key Exclusion Criteria: PK Phase:
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 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.
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).
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.
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.
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.
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.
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.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
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.
Single dose niraparib tablet followed by single dose niraparib capsule followed by optional daily dosing extension phase
Drug: Niraparib Tablet · Drug: Niraparib Capsule
Single dose niraparib capsule followed by single dose niraparib tablet followed by optional daily dosing extension phase
Drug: Niraparib Tablet · Drug: Niraparib Capsule
Single dose niraparib tablet followed by single dose niraparib capsule followed by optional daily dosing extension phase.
Drug: Niraparib Tablet · Drug: Niraparib Capsule
Single dose niraparib capsule followed by single dose niraparib tablet followed by optional daily dosing extension phase
Drug: Niraparib Tablet · Drug: Niraparib Capsule
Single dose niraparib tablet with a high fat meal followed by single dose of niraparib tablet in a fasted state.
Drug: Niraparib Tablet
Single dose niraparib tablet in a fasted state followed by single dose Niraparib tablet with a high fat meal.
Drug: Niraparib Tablet
Niraparib tablet formulation
Niraparib capsule formulation
Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t]) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0 to Inf]) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0 to inf). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Maximum Observed Plasma Concentration (Cmax) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Terminal Half-life (T1/2) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Apparent Total Body Clearance (CL/F) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Apparent Terminal Volume of Distribution (Vz/F) for Niraparib-Stage 1 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
AUC(0-t) for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
AUC(0 to Inf) for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0 to inf). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Cmax for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Tmax for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
T1/2 for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
CL/F for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Vz/F for Niraparib-Stage 2 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
AUC(0-t) for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
AUC(0 to Inf) for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0 to inf). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Cmax for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Tmax for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
T1/2 for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
CL/F for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Vz/F for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Time From Administration of the Dose to the First Quantifiable Concentration (Tlag) for Niraparib-Stage 3 PK Phase
Blood samples were collected at indicated time points for pharmacokinetic assessment of tlag. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
Time frame: Pre-dose, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose in each treatment period
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs-Stage 1 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is 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 is an important medical event. 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. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
Time frame: Up to 16 days
Number of Participants With TEAEs Leading to Discontinuation -Stage 1 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. 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 leading to discontinuation is reported. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
Time frame: Up to 16 days
Number of Participants With TEAEs and Serious TEAEs-Stage 2 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An SAE is 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 is an important medical event. 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. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
Time frame: Up to 24 days
Number of Participants With TEAEs-leading to Discontinuation Stage 2 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Number of participants with TEAEs leading to discontinuation is reported. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
Time frame: Up to 24 days
Number of Participants With TEAEs and Serious TEAEs-Stage 3 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An SAE is 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 is an important medical event. 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. TEAEs reported under Niraparib tablets under fasted and fed arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet fasted and fed, respectively.
Time frame: Up to 45 days
Number of Participants With TEAEs-leading to Discontinuation Stage 3 PK Phase (Periods 1 and 2 Only)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Number of participants with TEAEs leading to discontinuation is reported. TEAEs reported under Niraparib tablets under fasted and fed arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet fasted and fed, respectively.
Time frame: Up to 45 days
Number of Participants With TEAEs and Serious TEAEs - Extension Phase
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An SAE is 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 is an important medical event. 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. A summary of number of participants with any TEAEs and serious TEAEs is presented. Serious TEAEs are subset of TEAEs. TEAEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
Time frame: Up to approximately 5 years 5 months
Number of Participants With TEAEs-leading to Discontinuation - Extension Phase
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. 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. A summary of number of participants who discontinued due to any TEAEs is presented. TEAEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
Time frame: Up to approximately 5 years 5 months
This was a 3-stage, single cross-over study. The study had a pharmacokinetic (PK) phase consisting of stages 1, 2, and 3 and an Extension Phase. The Extension Phase based on Investigator and Sponsor's decision provided qualifying participants continued access to niraparib therapy.
| Milestone | Stage 1: Niraparib Tablet/Capsule | Stage 1: Niraparib Capsule/Tablet | Stage 2: Niraparib Tablet/Capsule | Stage 2: Niraparib Capsule/Tablet | Stage 3: Niraparib Tablet Fasted/Fed | Stage 3: Niraparib Tablet Fed/Fasted | Extension Phase: Niraparib Tablet | Extension Phase: Niraparib Capsule |
|---|---|---|---|---|---|---|---|---|
| Started | 15 | 14 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 15 | 14 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Stage 1: Niraparib Tablet/Capsule | Stage 1: Niraparib Capsule/Tablet | Stage 2: Niraparib Tablet/Capsule | Stage 2: Niraparib Capsule/Tablet | Stage 3: Niraparib Tablet Fasted/Fed | Stage 3: Niraparib Tablet Fed/Fasted | Extension Phase: Niraparib Tablet | Extension Phase: Niraparib Capsule |
|---|---|---|---|---|---|---|---|---|
| Started | 15 | 14 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 15 | 14 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Stage 1: Niraparib Tablet/Capsule | Stage 1: Niraparib Capsule/Tablet | Stage 2: Niraparib Tablet/Capsule | Stage 2: Niraparib Capsule/Tablet | Stage 3: Niraparib Tablet Fasted/Fed | Stage 3: Niraparib Tablet Fed/Fasted | Extension Phase: Niraparib Tablet | Extension Phase: Niraparib Capsule |
|---|---|---|---|---|---|---|---|---|
| Started | 15 | 14 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 15 | 14 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Stage 1: Niraparib Tablet/Capsule | Stage 1: Niraparib Capsule/Tablet | Stage 2: Niraparib Tablet/Capsule | Stage 2: Niraparib Capsule/Tablet | Stage 3: Niraparib Tablet Fasted/Fed | Stage 3: Niraparib Tablet Fed/Fasted | Extension Phase: Niraparib Tablet | Extension Phase: Niraparib Capsule |
|---|---|---|---|---|---|---|---|---|
| Started | 15 | 14 | 0 | 0 | 0 | 0 | 0 | 0 |
| Completed | 15 | 14 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Stage 1: Niraparib Tablet/Capsule | Stage 1: Niraparib Capsule/Tablet | Stage 2: Niraparib Tablet/Capsule | Stage 2: Niraparib Capsule/Tablet | Stage 3: Niraparib Tablet Fasted/Fed | Stage 3: Niraparib Tablet Fed/Fasted | Extension Phase: Niraparib Tablet | Extension Phase: Niraparib Capsule |
|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 90 | 89 | 0 | 0 | 0 | 0 |
| Treatment received | 0 | 0 | 85 | 83 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 85 | 83 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 5 | 6 | 0 | 0 | 0 | 0 |
| Withdrew: Randomized, but did not receive treatment | 0 | 0 | 5 | 6 | 0 | 0 | 0 | 0 |
| Milestone | Stage 1: Niraparib Tablet/Capsule | Stage 1: Niraparib Capsule/Tablet | Stage 2: Niraparib Tablet/Capsule | Stage 2: Niraparib Capsule/Tablet | Stage 3: Niraparib Tablet Fasted/Fed | Stage 3: Niraparib Tablet Fed/Fasted | Extension Phase: Niraparib Tablet | Extension Phase: Niraparib Capsule |
|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 85 | 83 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 69 | 71 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 16 | 12 | 0 | 0 | 0 | 0 |
| Withdrew: Deemed unevaluable | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Sponsor discontinued the participant | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Sponsor and investigator decision | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Participant had incorrectly overdosed and removed from pk phase | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Participant admitted to emergency room for elevated serum creatinine | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Participant unable to complete due to tornado in site area | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Participant non-compliance | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Vomiting within protocol-specified hours of dose administration | 0 | 0 | 2 | 2 | 0 | 0 | 0 | 0 |
| Withdrew: Protocol violation | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Disease progression per investigator decision | 0 | 0 | 3 | 3 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 5 | 2 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 |
| Milestone | Stage 1: Niraparib Tablet/Capsule | Stage 1: Niraparib Capsule/Tablet | Stage 2: Niraparib Tablet/Capsule | Stage 2: Niraparib Capsule/Tablet | Stage 3: Niraparib Tablet Fasted/Fed | Stage 3: Niraparib Tablet Fed/Fasted | Extension Phase: Niraparib Tablet | Extension Phase: Niraparib Capsule |
|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 69 | 71 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 69 | 71 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Stage 1: Niraparib Tablet/Capsule | Stage 1: Niraparib Capsule/Tablet | Stage 2: Niraparib Tablet/Capsule | Stage 2: Niraparib Capsule/Tablet | Stage 3: Niraparib Tablet Fasted/Fed | Stage 3: Niraparib Tablet Fed/Fasted | Extension Phase: Niraparib Tablet | Extension Phase: Niraparib Capsule |
|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 69 | 71 | 0 | 0 | 0 | 0 |
| Completed | 0 | 0 | 64 | 66 | 0 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 5 | 5 | 0 | 0 | 0 | 0 |
| Withdrew: Participant had paracentesis | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Participant forgot appointment | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Participant missed pk sampling in period 1 day 8 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Deemed unevaluable | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Participant was not in fasted state and therefore was outside of protocol compliance | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Disease progression per investigator decision | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 |
| Milestone | Stage 1: Niraparib Tablet/Capsule | Stage 1: Niraparib Capsule/Tablet | Stage 2: Niraparib Tablet/Capsule | Stage 2: Niraparib Capsule/Tablet | Stage 3: Niraparib Tablet Fasted/Fed | Stage 3: Niraparib Tablet Fed/Fasted | Extension Phase: Niraparib Tablet | Extension Phase: Niraparib Capsule |
|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 14 | 14 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 11 | 12 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 3 | 2 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Withdrew: Clinical progression | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Progressive disease | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Milestone | Stage 1: Niraparib Tablet/Capsule | Stage 1: Niraparib Capsule/Tablet | Stage 2: Niraparib Tablet/Capsule | Stage 2: Niraparib Capsule/Tablet | Stage 3: Niraparib Tablet Fasted/Fed | Stage 3: Niraparib Tablet Fed/Fasted | Extension Phase: Niraparib Tablet | Extension Phase: Niraparib Capsule |
|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 11 | 12 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 11 | 12 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Stage 1: Niraparib Tablet/Capsule | Stage 1: Niraparib Capsule/Tablet | Stage 2: Niraparib Tablet/Capsule | Stage 2: Niraparib Capsule/Tablet | Stage 3: Niraparib Tablet Fasted/Fed | Stage 3: Niraparib Tablet Fed/Fasted | Extension Phase: Niraparib Tablet | Extension Phase: Niraparib Capsule |
|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 11 | 12 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 10 | 11 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| Withdrew: Vomiting within protocol-specified hours of dose administration | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 |
| Milestone | Stage 1: Niraparib Tablet/Capsule | Stage 1: Niraparib Capsule/Tablet | Stage 2: Niraparib Tablet/Capsule | Stage 2: Niraparib Capsule/Tablet | Stage 3: Niraparib Tablet Fasted/Fed | Stage 3: Niraparib Tablet Fed/Fasted | Extension Phase: Niraparib Tablet | Extension Phase: Niraparib Capsule |
|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 10 | 11 | 0 | 0 |
| Completed | 0 | 0 | 0 | 0 | 10 | 11 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Milestone | Stage 1: Niraparib Tablet/Capsule | Stage 1: Niraparib Capsule/Tablet | Stage 2: Niraparib Tablet/Capsule | Stage 2: Niraparib Capsule/Tablet | Stage 3: Niraparib Tablet Fasted/Fed | Stage 3: Niraparib Tablet Fed/Fasted | Extension Phase: Niraparib Tablet | Extension Phase: Niraparib Capsule |
|---|---|---|---|---|---|---|---|---|
| Started | 0 | 0 | 0 | 0 | 0 | 0 | 124 | 66 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 53 | 36 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 71 | 30 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 0 | 0 | 0 | 22 | 14 |
| Withdrew: Lost to follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 |
| Withdrew: Death | 0 | 0 | 0 | 0 | 0 | 0 | 15 | 3 |
| Withdrew: Other reasons | 0 | 0 | 0 | 0 | 0 | 0 | 30 | 13 |
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Hours*nanogram per milliliter | Stage 1: Niraparib Tablet | Stage 1: Niraparib Capsule |
|---|---|---|
| Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUC[0-t]) for Niraparib-Stage 1 PK Phase | 14900 ± 43.0 | 16100 ± 41.3 |
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0 to inf). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Hours*nanogram per milliliter | Stage 1: Niraparib Tablet | Stage 1: Niraparib Capsule |
|---|---|---|
| Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC[0 to Inf]) for Niraparib-Stage 1 PK Phase | 16200 ± 44.5 | 17200 ± 41.8 |
Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Nanograms per milliliter | Stage 1: Niraparib Tablet | Stage 1: Niraparib Capsule |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) for Niraparib-Stage 1 PK Phase | 451 ± 47.8 | 467 ± 50.0 |
Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Hours | Stage 1: Niraparib Tablet | Stage 1: Niraparib Capsule |
|---|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for Niraparib-Stage 1 PK Phase | 4.05 (1.98 to 8.00) | 4.00 (1.52 to 25.02) |
Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Hours | Stage 1: Niraparib Tablet | Stage 1: Niraparib Capsule |
|---|---|---|
| Terminal Half-life (T1/2) for Niraparib-Stage 1 PK Phase | 47.3 ± 22.2 | 43.8 ± 23.1 |
Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Liters per hour | Stage 1: Niraparib Tablet | Stage 1: Niraparib Capsule |
|---|---|---|
| Apparent Total Body Clearance (CL/F) for Niraparib-Stage 1 PK Phase | 18.5 ± 44.5 | 17.4 ± 41.8 |
Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Liters | Stage 1: Niraparib Tablet | Stage 1: Niraparib Capsule |
|---|---|---|
| Apparent Terminal Volume of Distribution (Vz/F) for Niraparib-Stage 1 PK Phase | 1260 ± 45.4 | 1100 ± 43.1 |
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Hours*nanogram per milliliter | Stage 2: Niraparib Tablet | Stage 2: Niraparib Capsule |
|---|---|---|
| AUC(0-t) for Niraparib-Stage 2 PK Phase | 17070 ± 57.1 | 17730 ± 54.1 |
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0 to inf). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Hours*nanogram per milliliter | Stage 2: Niraparib Tablet | Stage 2: Niraparib Capsule |
|---|---|---|
| AUC(0 to Inf) for Niraparib-Stage 2 PK Phase | 17760 ± 55.3 | 18470 ± 53.5 |
Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Nanograms per milliliter | Stage 2: Niraparib Tablet | Stage 2: Niraparib Capsule |
|---|---|---|
| Cmax for Niraparib-Stage 2 PK Phase | 519.5 ± 49.5 | 538.4 ± 49.4 |
Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Hours | Stage 2: Niraparib Tablet | Stage 2: Niraparib Capsule |
|---|---|---|
| Tmax for Niraparib-Stage 2 PK Phase | 5.00 (1.55 to 8.00) | 4.97 (0.970 to 23.8) |
Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Hours | Stage 2: Niraparib Tablet | Stage 2: Niraparib Capsule |
|---|---|---|
| T1/2 for Niraparib-Stage 2 PK Phase | 47.94 ± 26.4 | 50.17 ± 26.1 |
Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Liters per hour | Stage 2: Niraparib Tablet | Stage 2: Niraparib Capsule |
|---|---|---|
| CL/F for Niraparib-Stage 2 PK Phase | 16.89 ± 55.3 | 16.25 ± 53.5 |
Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Liters | Stage 2: Niraparib Tablet | Stage 2: Niraparib Capsule |
|---|---|---|
| Vz/F for Niraparib-Stage 2 PK Phase | 1128 ± 51.1 | 1128 ± 50.9 |
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0-t). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Hours*nanogram per milliliter | Stage 3: Niraparib Tablet Fasted | Stage 3: Niraparib Tablet Fed |
|---|---|---|
| AUC(0-t) for Niraparib-Stage 3 PK Phase | 20100 ± 63.9 | 25990 ± 52.4 |
Blood samples were collected at indicated time points for pharmacokinetic assessment of AUC(0 to inf). Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Hours*nanogram per milliliter | Stage 3: Niraparib Tablet Fasted | Stage 3: Niraparib Tablet Fed |
|---|---|---|
| AUC(0 to Inf) for Niraparib-Stage 3 PK Phase | 23600 ± 78.5 | 29770 ± 65.2 |
Blood samples were collected at indicated time points for pharmacokinetic assessment of Cmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Nanograms per milliliter | Stage 3: Niraparib Tablet Fasted | Stage 3: Niraparib Tablet Fed |
|---|---|---|
| Cmax for Niraparib-Stage 3 PK Phase | 704.1 ± 57.0 | 774.6 ± 47.2 |
Blood samples were collected at indicated time points for pharmacokinetic assessment of Tmax. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Hours | Stage 3: Niraparib Tablet Fasted | Stage 3: Niraparib Tablet Fed |
|---|---|---|
| Tmax for Niraparib-Stage 3 PK Phase | 4.88 (2.97 to 7.10) | 5.97 (0.980 to 11.1) |
Blood samples were collected at indicated time points for pharmacokinetic assessment of T1/2. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Hours | Stage 3: Niraparib Tablet Fasted | Stage 3: Niraparib Tablet Fed |
|---|---|---|
| T1/2 for Niraparib-Stage 3 PK Phase | 46.39 ± 20.5 | 46.08 ± 22.4 |
Blood samples were collected at indicated time points for pharmacokinetic assessment of CL/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Liters per hour | Stage 3: Niraparib Tablet Fasted | Stage 3: Niraparib Tablet Fed |
|---|---|---|
| CL/F for Niraparib-Stage 3 PK Phase | 12.71 ± 78.5 | 10.08 ± 65.2 |
Blood samples were collected at indicated time points for pharmacokinetic assessment of Vz/F. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Liters | Stage 3: Niraparib Tablet Fasted | Stage 3: Niraparib Tablet Fed |
|---|---|---|
| Vz/F for Niraparib-Stage 3 PK Phase | 833.8 ± 83.5 | 651.4 ± 54.3 |
Blood samples were collected at indicated time points for pharmacokinetic assessment of tlag. Pharmacokinetic parameters were calculated using standard non-compartmental analysis.
| Hours | Stage 3: Niraparib Tablet Fasted | Stage 3: Niraparib Tablet Fed |
|---|---|---|
| Time From Administration of the Dose to the First Quantifiable Concentration (Tlag) for Niraparib-Stage 3 PK Phase | 0.00 (0.00 to 0.970) | 0.00 (0.00 to 2.93) |
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. A serious adverse event (SAE) is 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 is an important medical event. 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. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
| Participants | Stage 1: Niraparib Tablet | Stage 1: Niraparib Capsule |
|---|---|---|
| TEAE | 9 | 12 |
| Serious TEAE | 0 | 0 |
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. 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 leading to discontinuation is reported. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
| Participants | Stage 1: Niraparib Tablet | Stage 1: Niraparib Capsule |
|---|---|---|
| Number of Participants With TEAEs Leading to Discontinuation -Stage 1 PK Phase (Periods 1 and 2 Only) | 0 | 0 |
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An SAE is 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 is an important medical event. 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. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
| Participants | Stage 2: Niraparib Tablet | Stage 2: Niraparib Capsule |
|---|---|---|
| TEAE | 86 | 73 |
| Serious TEAE | 10 | 10 |
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Number of participants with TEAEs leading to discontinuation is reported. TEAEs reported under Niraparib tablet and Niraparib capsule arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet and capsule, respectively.
| Participants | Stage 2: Niraparib Tablet | Stage 2: Niraparib Capsule |
|---|---|---|
| Number of Participants With TEAEs-leading to Discontinuation Stage 2 PK Phase (Periods 1 and 2 Only) | 2 | 2 |
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An SAE is 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 is an important medical event. 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. TEAEs reported under Niraparib tablets under fasted and fed arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet fasted and fed, respectively.
| Participants | Stage 3: Niraparib Tablet Fasted | Stage 3: Niraparib Tablet Fed |
|---|---|---|
| TEAE | 8 | 12 |
| Serious TEAE | 4 | 2 |
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Number of participants with TEAEs leading to discontinuation is reported. TEAEs reported under Niraparib tablets under fasted and fed arms include TEAEs with onset date during the corresponding period (Period 1 or Period 2) in which the participant received niraparib tablet fasted and fed, respectively.
| Participants | Stage 3: Niraparib Tablet Fasted | Stage 3: Niraparib Tablet Fed |
|---|---|---|
| Number of Participants With TEAEs-leading to Discontinuation Stage 3 PK Phase (Periods 1 and 2 Only) | 1 | 1 |
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An SAE is 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 is an important medical event. 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. A summary of number of participants with any TEAEs and serious TEAEs is presented. Serious TEAEs are subset of TEAEs. TEAEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
| Participants | Extension Phase: Niraparib Tablet | Extension Phase: Niraparib Capsule |
|---|---|---|
| TEAEs | 120 | 65 |
| Serious TEAEs | 40 | 20 |
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. 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. A summary of number of participants who discontinued due to any TEAEs is presented. TEAEs were coded using the Medical Dictionary for Regulatory Affairs (MedDRA dictionary).
| Participants | Extension Phase: Niraparib Tablet | Extension Phase: Niraparib Capsule |
|---|---|---|
| Number of Participants With TEAEs-leading to Discontinuation - Extension Phase | 8 | 9 |
Collected over All-cause mortality, non-serious TEAEs and serious TEAEs were collected up to approximately 5 years 6 months.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stage 1: Niraparib Tablet | 0/29 (0%) | 0/29 (0%) | 2/29 (6.9%) |
| Stage 1: Niraparib Capsule | 0/29 (0%) | 0/29 (0%) | 7/29 (24.1%) |
| Stage 2: Niraparib Tablet | 2/156 (1.3%) | 10/156 (6.4%) | 49/156 (31.4%) |
| Stage 2: Niraparib Capsule | 5/152 (3.3%) | 10/152 (6.6%) | 37/152 (24.3%) |
| Stage 3: Niraparib Tablet Fasted | 2/26 (7.7%) | 4/26 (15.4%) | 6/26 (23.1%) |
| Stage 3: Niraparib Tablet Fed | 0/25 (0%) | 2/25 (8%) | 5/25 (20%) |
| Extension Phase: Niraparib Tablet | 15/124 (12.1%) | 40/124 (32.3%) | 113/124 (91.1%) |
| Extension Phase: Niraparib Capsule | 3/66 (4.5%) | 20/66 (30.3%) | 64/66 (97%) |
| Event | Stage 1: Niraparib Tablet | Stage 1: Niraparib Capsule | Stage 2: Niraparib Tablet | Stage 2: Niraparib Capsule | Stage 3: Niraparib Tablet Fasted | Stage 3: Niraparib Tablet Fed | Extension Phase: Niraparib Tablet | Extension Phase: Niraparib Capsule |
|---|---|---|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 0/29 | 0/29 | 9/156 | 8/152 | 0/26 | 2/25 | 0/124 | 3/66 |
| ConstipationGastrointestinal disorders | 0/29 | 0/29 | 2/156 | 1/152 | 2/26 | 0/25 | 0/124 | 0/66 |
| Small intestinal obstructionGastrointestinal disorders | 0/29 | 0/29 | 0/156 | 0/152 | 0/26 | 0/25 | 2/124 | 3/66 |
| Pleural effusionRespiratory, thoracic and mediastinal disorders | 0/29 | 0/29 | 0/156 | 0/152 | 0/26 | 1/25 | 0/124 | 0/66 |
| InfectionInfections and infestations | 0/29 | 0/29 | 0/156 | 0/152 | 0/26 | 1/25 | 0/124 | 0/66 |
| Abdominal painGastrointestinal disorders | 0/29 | 0/29 | 2/156 | 1/152 | 1/26 | 0/25 | 3/124 | 2/66 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 0/29 | 0/29 | 0/156 | 0/152 | 1/26 | 0/25 | 4/124 | 1/66 |
| Duodenal obstructionGastrointestinal disorders | 0/29 | 0/29 | 0/156 | 0/152 | 1/26 | 0/25 | 0/124 | 0/66 |
| Biliary obstructionHepatobiliary disorders | 0/29 | 0/29 | 0/156 | 0/152 | 1/26 | 0/25 | 0/124 | 0/66 |
| Failure to thriveMetabolism and nutrition disorders | 0/29 | 0/29 | 0/156 | 0/152 | 1/26 | 0/25 | 0/124 | 0/66 |
| Event | Stage 1: Niraparib Tablet | Stage 1: Niraparib Capsule | Stage 2: Niraparib Tablet | Stage 2: Niraparib Capsule | Stage 3: Niraparib Tablet Fasted | Stage 3: Niraparib Tablet Fed | Extension Phase: Niraparib Tablet | Extension Phase: Niraparib Capsule |
|---|---|---|---|---|---|---|---|---|
| NauseaGastrointestinal disorders | 1/29 | 5/29 | 17/156 | 13/152 | 2/26 | 2/25 | 47/124 | 28/66 |
| FatigueGeneral disorders | 1/29 | 2/29 | 12/156 | 8/152 | 0/26 | 0/25 | 34/124 | 22/66 |
| VomitingGastrointestinal disorders | 1/29 | 2/29 | 10/156 | 8/152 | 2/26 | 1/25 | 39/124 | 19/66 |
| AnaemiaBlood and lymphatic system disorders | 0/29 | 0/29 | 9/156 | 8/152 | 0/26 | 2/25 | 35/124 | 20/66 |
| ConstipationGastrointestinal disorders | 0/29 | 0/29 | 16/156 | 10/152 | 2/26 | 0/25 | 31/124 | 11/66 |
| Decreased appetiteMetabolism and nutrition disorders | 0/29 | 0/29 | 0/156 | 0/152 | 0/26 | 0/25 | 28/124 | 6/66 |
| Abdominal painGastrointestinal disorders | 0/29 | 0/29 | 0/156 | 0/152 | 0/26 | 2/25 | 12/124 | 12/66 |
| Back painMusculoskeletal and connective tissue disorders | 0/29 | 0/29 | 0/156 | 0/152 | 0/26 | 0/25 | 3/124 | 12/66 |
| Platelet count decreasedInvestigations | 0/29 | 0/29 | 0/156 | 0/152 | 2/26 | 0/25 | 19/124 | 8/66 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/29 | 0/29 | 0/156 | 0/152 | 0/26 | 0/25 | 18/124 | 8/66 |
Baseline characteristics were presented for Safety Population, all participants who received any amount of niraparib during the PK phase of study.
| Age, Customized(Participants) | Stage 1: Niraparib Tablet/Capsule | Stage 1: Niraparib Capsule/Tablet | Stage 2: Niraparib Tablet/Capsule | Stage 2: Niraparib Capsule/Tablet | Stage 3: Niraparib Tablet Fasted/Fed | Stage 3: Niraparib Tablet Fed/Fasted | Total |
|---|---|---|---|---|---|---|---|
| <18 to <65 years | 5 | 7 | 43 | 38 | 6 | 9 | 108 |
| >=65 to <75 years | 9 | 4 | 27 | 32 | 7 | 1 | 80 |
| >=75 years | 1 | 3 | 15 | 13 | 1 | 4 | 37 |
| Sex: Female, Male(Participants) | Stage 1: Niraparib Tablet/Capsule | Stage 1: Niraparib Capsule/Tablet | Stage 2: Niraparib Tablet/Capsule | Stage 2: Niraparib Capsule/Tablet | Stage 3: Niraparib Tablet Fasted/Fed | Stage 3: Niraparib Tablet Fed/Fasted | Total |
|---|---|---|---|---|---|---|---|
| Female | 9 | 9 | 48 | 48 | 5 | 6 | 125 |
| Male | 6 | 5 | 37 | 35 | 9 | 8 | 100 |
| Race/Ethnicity, Customized(Participants) | Stage 1: Niraparib Tablet/Capsule | Stage 1: Niraparib Capsule/Tablet | Stage 2: Niraparib Tablet/Capsule | Stage 2: Niraparib Capsule/Tablet | Stage 3: Niraparib Tablet Fasted/Fed | Stage 3: Niraparib Tablet Fed/Fasted | Total |
|---|---|---|---|---|---|---|---|
| White | 14 | 14 | 63 | 62 | 8 | 10 | 171 |
| African American | 1 | 0 | 11 | 11 | 5 | 0 | 28 |
| Asian | 0 | 0 | 5 | 3 | 0 | 0 | 8 |
| American Indian or Alaska Native | 0 | 0 | 2 | 0 | 0 | 0 | 2 |
| Unknown | 0 | 0 | 4 | 7 | 1 | 4 | 16 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — GSK will assess requests from qualified researchers for anonymized individual patient-level data (IPD) and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Access criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Data sharing details ↗ · www.gsk-studyregister.com
Ran from Dec 2017 to primary completion in Dec 2021, 48 months.
Results were first posted in Apr 2024, 2 years 3 months after primary completion.
Of 677 industry-sponsored phase 1 interventional studies under Neoplasms, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 61. This study's 48 months is above that.
Counting every sponsor, half of 904 studies reached it within 40 months; a quarter within 23 and three quarters within 64.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Niraparib