A Phase 2 interventional study of Niraparib 200 mg and Cetrelimab 240 mg in Prostatic Neoplasms, Castration-Resistant, sponsored by Janssen Research & Development, LLC. Active, not recruiting at 50 sites in 7 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Janssen Research & Development, LLC (part of Johnson & Johnson) · Phase 2, Interventional, and Treatment
Among 50 studies in Prostatic Neoplasms, Castration-Resistant with a site in United States — 17 open to participants now, 23 under way, 3 of them phase 3. Prostatic Neoplasms, Castration-Resistant · United States.
Among the 50 studies in Prostatic Neoplasms, Castration-Resistant with a site in United States, this one is the 17th largest by enrollment of the 42 interventional ones, is one of 5 that started in 2018, is one of 9 in phase 2, reaches primary completion later than 0 of the 22 other live ones, and was the 10th registered.
85 studies on the registry are indexed under Prostatic Neoplasms, Castration-Resistant; 28 are open to participants now.
This study's enrollment of 136 is above the median of 82 across 62 interventional studies indexed under Prostatic Neoplasms, Castration-Resistant.
Browse Prostatic Neoplasms, Castration-Resistant studies →17 of the 50 studies in Prostatic Neoplasms, Castration-Resistant with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 25 Prostatic Neoplasms, Castration-Resistant studies recruiting now, 22 (88%) set no upper age limit and 0 (0%) stop at 75 or younger; 1 take children under 18; 0 take healthy volunteers.
This study: 18 Years and older · male · no healthy volunteers.
The full table on the hub →50 studies; the count open now beside each. This study's row is marked.
First in 2014; this study’s year is marked. 5 started in 2018.
Median enrollment 91 across the 42 interventional studies, 1,908 across the 6 observational. Of the 23 that completed or were terminated, 11 (48%) have results posted.
41 of 50 have an industry lead sponsor. The 10 most frequent:
Janssen Research & Development, LLC is the lead sponsor of 932 studies on the registry; 76 are open to participants now.
Of its 285 completed or terminated interventional studies of FDA-regulated products, 136 (48%) have results posted.
Janssen Research & Development, LLC has 8 studies filed under Prostatic Neoplasms, Castration-Resistant — fewer than ten, so there is no comparison to draw.
8 of the studies in Prostatic Neoplasms, Castration-Resistant with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07225946Phase 3Janssen Research & Development, LLCA Study of Pasritamig With Docetaxel Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer | 2027-11-19 |
| NCT07697989Novartis PharmaceuticalsPluvicto Real-world Investigation in Survival in Metastatic CRPC | 2027-01-31 |
| NCT07677254Novartis PharmaceuticalsA Study of Real-World Characteristics, Treatment Patterns, and Clinical Outcomes in Patients With Metastatic Castration-Resistant Prostate Cancer | 2027-05-31 |
| NCT07677267Novartis PharmaceuticalsA Study of Real-World Characteristics, Treatment Patterns, and Outcomes Among mCRPC Patients Previously Treated With an Androgen Receptor Pathway Inhibitor, Taxane-Based Chemotherapy, and Lutetium-177 Vipivotide Tetraxetan | 2027-05-31 |
| NCT05519449Janux TherapeuticsStudy of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01) | 2027-07 |
Among the 50 studies in Prostatic Neoplasms, Castration-Resistant with a site in United States, from their registry updates:
The purpose of this study is to: a) establish the recommended phase 2 dose (RP2D) and to evaluate the antitumor activity and safety of niraparib combination therapies (Combinations 1 and 2) and b) to determine the relative bioavailability of niraparib and abiraterone acetate (AA) in combination (Combination 3) in participants with metastatic castration-resistant prostate cancer (mCRPC).
This multicenter study will evaluate safety and efficacy of niraparib in combination with other anti-cancer agents. Combination 1 will combine niraparib with the anti-programmed cell death protein (PD)-1 monoclonal antibody cetrelimab, in participants with mCRPC. Combination 1 has 2 parts: in Part 1 (dose selection), participants will be enrolled to establish RP2D doses of niraparib and cetrelimab; and Part 2 (dose expansion) will evaluate the combination therapy in an expanded number of participants into 2 cohorts (biomarker positive or biomarker negative). Combination 2 will combine niraparib with abiraterone acetate plus prednisone (AA-P) in mCRPC participants with DNA-repair gene defects (DRD). Combination 3 will evaluate the relative bioavailability (BA) of niraparib and AA in combination. In a pharmacokinetics (PK) assessment phase, niraparib and AA will be administered, and in an extension phase, niraparib and AA-P will be administered. Combinations 1 and 2 will have 5 phases: A Pre-screening Phase, a Screening Phase, a Treatment Phase, a Follow-up Phase, and a Long-term Extension (LTE) Phase; Combination 3 has 3 phases: A Screening Phase, A PK Assessment Phase, an Extension Phase (including LTE phase). Study evaluations will include efficacy, PK, PK/pharmacodynamics, biomarkers, safety and tolerability.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Combination 3:
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.
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.
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.
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 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.
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.
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.
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.
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.
Dose regimen 1: The participants will receive niraparib 200 milligram (mg) orally once daily in combination with cetrelimab 240 mg intravenously (IV) once every 2 weeks. Dose regimen 2: The participants will receive niraparib 200 mg orally once daily in combination with cetrelimab 480 mg IV once every 4 weeks in 28-day treatment cycles until disease progression, unacceptable toxicity, death, or the sponsor terminates the study. The safety evaluation team (SET) will determine if an additional cohort is necessary, based on the data from dose regimens 1 and 2. Participants in the Treatment Phase of this combination will be offered the option to enter the Long-term Extension Phase of the study.
Drug: Niraparib 200 mg · Drug: Cetrelimab 240 mg · Drug: Cetrelimab 480 mg
Participants will be assigned to either Cohort 1A (Biomarker \[BM\] positive \[+\]) or Cohort 1B (BM negative \[-\]) and will receive established RP2D of cetrelimab and niraparib, in Part 2 until disease progression, unacceptable toxicity, death, or the sponsor terminates the study. A futility analysis will be performed for the Cohort 1B after 10 BM- participants are enrolled in Part 2. This cohort will be closed if the response is less than predetermined response rate as outlined in the protocol. Participants in the Treatment Phase of this combination will be offered the option to enter the Long-term Extension Phase of the study.
Drug: Niraparib 200 mg · Drug: Cetrelimab 480 mg
Participants will be assigned to one of 4 cohorts based on biomarker status - Cohort 2A (BRCA biallelic loss), 2B (other DRD biallelic loss), 2C (BRCA monoallelic loss), or 2D (other DRD monoallelic loss), and will receive niraparib 200 mg once daily in combination with abiraterone acetate 1000 mg (4\*250 mg) plus 10 mg prednisone (5 mg twice daily) throughout treatment phase. Participants in the Treatment Phase of this combination will be offered the option to enter the Long-term Extension Phase of the study.
Drug: Niraparib 200 mg · Drug: Abiraterone acetate 1000 mg · Drug: Prednisone 5 mg
Participants will be assigned to one of three cohorts to receive AA-P with or without niraparib. Participants in the Treatment Phase of this combination will be offered the option to enter the Long-term Extension Phase of the study.
Drug: Niraparib 200 mg · Drug: Abiraterone acetate 1000 mg · Drug: Prednisone 5 mg
Participants will receive niraparib 200 mg orally.
Participants will receive cetrelimab 240 mg IV every 2 weeks.
Also known as: JNJ-63723283
Participants will receive cetrelimab 480 mg IV every 4 weeks.
Also known as: JNJ-63723283
Participants will receive AA 1000 mg orally.
Participants will receive prednisone 5 mg orally.
Combination 1: Part 1: Number of Participants With Specified Toxicity
Number of participants with specified toxicity during Cycle 1 was reported. Only toxicities that occurred during safety evaluation period(defined as first 28 days of treatment-Cycle 1 of Part 1) was used for analysis of specified toxicities and for dose reduction decisions. Toxicities were graded for severity as per NCI-CTCAE, version 4.03. Safety evaluation criteria were: Any Grade(G) \>=3 non-hematological toxicity without anorexia, or constipation, fatigue improved to G\<=2 in \<7 days, vomiting and diarrhea resolved in \<=3 days, laboratory abnormalities with hospitalization, tumor flare improved to G\<=2 in \<=7 days, elevation in AST/ALT for \<=7 days and G3 hypertension controlled by medical therapy; any treatment-related(TR)G4 or G\>=3 thrombocytopenia required platelet transfusion; Any TR G4 neutropenia \>=7 days or G3 or 4 neutropenia with infection/fever \>38.5 degrees Celsius; Any TR SAE or intolerable toxicity.
Time frame: Cycle 1 (28 days)
Combination 1: Part 2: Objective Response Rate (ORR)
ORR of soft tissue (visceral or nodal disease) was defined as percentage of participants with measurable disease who achieved a best response of either complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with no evidence of bone progression according to prostate cancer working group 3 (PCWG3) criteria.
Time frame: Up to 37 months
Combination 2: Composite Response Rate (RR)
Composite response rate was defined as the percentage of participants who had a composite response which is defined as one of the following PCWG3 criteria: Objective response (percentage of participants with measurable disease who achieved a best response of either CR or PR as assessed by RECIST 1.1 with no evidence of bone progression according to PCWG3 criteria) (confirmed per RECIST 1.1), or; circulating tumor cells (CTC) response: defined as CTC=0 per 7.5 milliliters (mL) of blood at 8 weeks for participants who had CTC greater than or equal to (\>=) 1 at baseline or CTC less than (\<) 5 per 7.5 mL with CTC \>=5 at baseline, confirmed by a second consecutive value obtained 4 or more weeks later, or prostate-specific antigen (PSA) declined of \>=50 percentage (%), measured twice 3 to 4 weeks apart. This outcome measure was analyzed for specified arms only as pre-planned in the protocol.
Time frame: Up to 31 months
Combination 1: Part 2: Number of Participants With Adverse Events (AEs)
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment.
Time frame: Up to 37 months
Combination 2: Number of Participants With Adverse Events (AEs)
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment.
Time frame: Up to 31 months
Combination 1: Part 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An assessment of severity grade was made using the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) as Grade 1 (mild): awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities; Grade 2 (moderate): sufficient discomfort is present to cause interference with normal activity; Grade 3 (severe): extreme distress, causing significant impairment of functioning or incapacitation, prevents normal everyday activities; Grade 4 (Life-threatening): urgent intervention indicated; and Grade 5 (death).
Time frame: Up to 37 months
Combination 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An assessment of severity grade was made using the NCI-CTCAE as Grade 1 (mild): awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities; Grade 2 (moderate): sufficient discomfort is present to cause interference with normal activity; Grade 3 (severe): extreme distress, causing significant impairment of functioning or incapacitation, prevents normal everyday activities; Grade 4 (Life-threatening): urgent intervention indicated; and Grade 5 (death).
Time frame: Up to 31 months
Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib and Abiraterone Acetate After a Single Dose
Cmax is defined as maximum observed plasma concentration of niraparib and abiraterone acetate (AA) after a single dose.
Time frame: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib Normalized by the Dose(Niraparib) (Cmax/Dose) of Niraparib Administered With AA After a Single Dose
Cmax/dose of niraparib was defined as maximum observed plasma concentration of niraparib Cmax normalized by the dose of niraparib administered with AA after a single dose.
Time frame: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Combination 3: Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC [0-168hr]) of Niraparib Administered With AA After a Single Dose
AUC(0-168 hours) was defined as area under the plasma concentration-time curve from time zero to 168 hours of Niraparib administered with AA After a single dose.
Time frame: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Combination 3: Area Under the Plasma Concentration-Time Curve for Niraparib From Time Zero to 168 Hours (AUC [0-168 Hours]/Dose) of Niraparib Administered With AA After a Single Dose
AUC0(168 hours)/dose was defined as area under the plasma concentration-time curve for niraparib from time 0 to 168 hours of niraparib administered with AA after a single dose.
Time frame: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Combination 1: Parts 1 and 2: Plasma Concentrations of Niraparib
Time frame: Day 1
Combination 1: Parts 1 and 2: Maximum Observed Plasma Concentration (Cmax) of Niraparib
Time frame: Day 1
Combination 1: Parts 1 and 2: Time to Reach the Maximum Plasma Concentration (Tmax) of Niraparib
Time frame: Day 1
Combination 1: Parts 1 and 2: Minimum Observed (Predose) Concentration Following Multiple Dosing (Ctrough) of Niraparib
Time frame: Day 1
Combination 1: Parts 1 and 2: Number of Participants With Anti-drug Antibodies of Niraparib
Time frame: From baseline up to end of study (6 years 10 months)
Combination 1: Part 2 and Combination 2: Circulating Tumor Cells (CTC) Response
Time frame: From baseline up to end of study (6 years 10 months)
Combination 1: Part 2: Composite Response Rate
Time frame: From baseline up to end of study (6 years 10 months)
Combination 2: Objective Response Rate (ORR)
Time frame: From baseline up to end of study (6 years 10 months)
Combination 1: Part 2 and Combination 2: Duration of Objective Response
Time frame: From baseline up to end of study (6 years 10 months)
Combination 1: Part 2 and Combination 2: Overall Survival
Time frame: From baseline up to end of study (6 years 10 months)
Combination 3: Cmax of Niraparib and Abiraterone Acetate After a Single Dose For Low-strength FDC
Time frame: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib Normalized by the Dose(Niraparib) (Cmax/Dose) of Niraparib Administered With AA After a Single Dose for Low-strength FDC
Time frame: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Combination 3: Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC [0-168hr]) of Niraparib Administered With AA After a Single Dose For Low-strength FDC
Time frame: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Combination 3: Area Under the Plasma Concentration-Time Curve for Niraparib From Time Zero to 168 Hours (AUC [0-168 Hours]/Dose) of Niraparib Administered With AA After a Single Dose For Low-strength FDC
Time frame: Pre-dose, 30 min, 1 hour (hr), 1.5 hr, 2hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 24 hr, 48 hr, 72 hr, and 168 hr post dose on Day 1
Combination 3: Number of Participants With Adverse Events
Time frame: From baseline up to end of study (6 years 10 months)
Combination 3: Number of Participants With Clinical Laboratory Parameters
Time frame: From baseline up to end of study (6 years 10 months)
| Milestone | Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg | Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg | Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg | Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg | Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone | Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA | Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) | Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) | Combination 3: Cohort 3: Niraparib + Abiraterone Acetate, FDC1-LS |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Started | 6 | 6 | 21 | 11 | 8 | 9 | 6 | 1 | 17 | 17 | 17 | 17 |
| Completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Not completed | 6 | 6 | 21 | 11 | 8 | 9 | 6 | 1 | 17 | 17 | 17 | 17 |
| Withdrew: Ongoing | 0 | 0 | 2 | 0 | 1 | 3 | 0 | 1 | 3 | 4 | 2 | 1 |
| Withdrew: Death | 6 | 5 | 18 | 7 | 4 | 3 | 2 | 0 | 0 | 0 | 4 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawal by subject | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 2 | 0 | 1 |
| Withdrew: Other | 0 | 0 | 1 | 3 | 2 | 2 | 4 | 0 | 14 | 11 | 11 | 15 |
Number of participants with specified toxicity during Cycle 1 was reported. Only toxicities that occurred during safety evaluation period(defined as first 28 days of treatment-Cycle 1 of Part 1) was used for analysis of specified toxicities and for dose reduction decisions. Toxicities were graded for severity as per NCI-CTCAE, version 4.03. Safety evaluation criteria were: Any Grade(G) \>=3 non-hematological toxicity without anorexia, or constipation, fatigue improved to G\<=2 in \<7 days, vomiting and diarrhea resolved in \<=3 days, laboratory abnormalities with hospitalization, tumor flare improved to G\<=2 in \<=7 days, elevation in AST/ALT for \<=7 days and G3 hypertension controlled by medical therapy; any treatment-related(TR)G4 or G\>=3 thrombocytopenia required platelet transfusion; Any TR G4 neutropenia \>=7 days or G3 or 4 neutropenia with infection/fever \>38.5 degrees Celsius; Any TR SAE or intolerable toxicity.
| Participants | Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg | Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg |
|---|---|---|
| Combination 1: Part 1: Number of Participants With Specified Toxicity | 0 | 0 |
ORR of soft tissue (visceral or nodal disease) was defined as percentage of participants with measurable disease who achieved a best response of either complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 with no evidence of bone progression according to prostate cancer working group 3 (PCWG3) criteria.
| Percentage of participants | Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg | Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg |
|---|---|---|
| Combination 1: Part 2: Objective Response Rate (ORR) | 23.8 (9.9 to 43.7) | 9.1 (0.5 to 36.4) |
Composite response rate was defined as the percentage of participants who had a composite response which is defined as one of the following PCWG3 criteria: Objective response (percentage of participants with measurable disease who achieved a best response of either CR or PR as assessed by RECIST 1.1 with no evidence of bone progression according to PCWG3 criteria) (confirmed per RECIST 1.1), or; circulating tumor cells (CTC) response: defined as CTC=0 per 7.5 milliliters (mL) of blood at 8 weeks for participants who had CTC greater than or equal to (\>=) 1 at baseline or CTC less than (\<) 5 per 7.5 mL with CTC \>=5 at baseline, confirmed by a second consecutive value obtained 4 or more weeks later, or prostate-specific antigen (PSA) declined of \>=50 percentage (%), measured twice 3 to 4 weeks apart. This outcome measure was analyzed for specified arms only as pre-planned in the protocol.
| Percentage of participants | Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone |
|---|---|---|---|
| Combination 2: Composite Response Rate (RR) | 75.0 (40.0 to 95.4) | 55.6 (25.1 to 83.1) | 33.3 (6.3 to 72.9) |
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment.
| Participants | Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg | Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg |
|---|---|---|
| Combination 1: Part 2: Number of Participants With Adverse Events (AEs) | 21 | 11 |
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment.
| Participants | Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone |
|---|---|---|---|---|
| Combination 2: Number of Participants With Adverse Events (AEs) | 8 | 9 | 5 | 1 |
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An assessment of severity grade was made using the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) as Grade 1 (mild): awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities; Grade 2 (moderate): sufficient discomfort is present to cause interference with normal activity; Grade 3 (severe): extreme distress, causing significant impairment of functioning or incapacitation, prevents normal everyday activities; Grade 4 (Life-threatening): urgent intervention indicated; and Grade 5 (death).
| Participants | Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg | Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg |
|---|---|---|
| Combination 1: Part 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity | 14 | 8 |
AE was defined as an any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An assessment of severity grade was made using the NCI-CTCAE as Grade 1 (mild): awareness of symptoms that are easily tolerated, causing minimal discomfort and not interfering with everyday activities; Grade 2 (moderate): sufficient discomfort is present to cause interference with normal activity; Grade 3 (severe): extreme distress, causing significant impairment of functioning or incapacitation, prevents normal everyday activities; Grade 4 (Life-threatening): urgent intervention indicated; and Grade 5 (death).
| Participants | Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone |
|---|---|---|---|---|
| Combination 2: Number of Participants With Adverse Events (AEs) of Grade >=3 Severity | 6 | 7 | 4 | 1 |
Cmax is defined as maximum observed plasma concentration of niraparib and abiraterone acetate (AA) after a single dose.
| Nanograms per milliliter (ng/mL) | Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA | Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) | Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) |
|---|---|---|---|
| Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib and Abiraterone Acetate After a Single Dose | 428 ± 189 | 398 ± 160 | 417 ± 176 |
Cmax/dose of niraparib was defined as maximum observed plasma concentration of niraparib Cmax normalized by the dose of niraparib administered with AA after a single dose.
| nanograms per milliliter per milligram | Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA | Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) | Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) |
|---|---|---|---|
| Combination 3: Maximum Observed Plasma Concentration (Cmax) of Niraparib Normalized by the Dose(Niraparib) (Cmax/Dose) of Niraparib Administered With AA After a Single Dose | 2.14 ± 0.95 | 1.99 ± 0.80 | 2.09 ± 0.88 |
AUC(0-168 hours) was defined as area under the plasma concentration-time curve from time zero to 168 hours of Niraparib administered with AA After a single dose.
| Nanograms*hour per milliliter (ng*h/mL) | Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA | Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) | Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) |
|---|---|---|---|
| Combination 3: Area Under the Plasma Concentration-Time Curve From Time Zero to 168 Hours (AUC [0-168hr]) of Niraparib Administered With AA After a Single Dose | 14672 ± 7346 | 11862 ± 4973 | 13321 ± 5843 |
AUC0(168 hours)/dose was defined as area under the plasma concentration-time curve for niraparib from time 0 to 168 hours of niraparib administered with AA after a single dose.
| nanogram*hour/milliliter/milligram | Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA | Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) | Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) |
|---|---|---|---|
| Combination 3: Area Under the Plasma Concentration-Time Curve for Niraparib From Time Zero to 168 Hours (AUC [0-168 Hours]/Dose) of Niraparib Administered With AA After a Single Dose | 73.36 ± 36.73 | 59.31 ± 24.87 | 66.61 ± 29.22 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over Combination 1: Part 1: Up to 42 months and Part 2: up to 37 months; Combination 2: up to 31 months; Combination 3: up to 18 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg | 6/6 (100%) | 2/6 (33.3%) | 6/6 (100%) |
| Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg | 5/6 (83.3%) | 3/6 (50%) | 6/6 (100%) |
| Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg | 18/21 (85.7%) | 12/21 (57.1%) | 21/21 (100%) |
| Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg | 7/11 (63.6%) | 6/11 (54.5%) | 11/11 (100%) |
| Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone | 5/8 (62.5%) | 4/8 (50%) | 8/8 (100%) |
| Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone | 4/9 (44.4%) | 5/9 (55.6%) | 9/9 (100%) |
| Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone | 2/6 (33.3%) | 1/6 (16.7%) | 5/6 (83.3%) |
| Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone | 0/1 (0%) | 1/1 (100%) | 1/1 (100%) |
| Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA | 3/17 (17.6%) | 4/17 (23.5%) | 10/17 (58.8%) |
| Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) | 1/17 (5.9%) | 4/17 (23.5%) | 10/17 (58.8%) |
| Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) | 4/17 (23.5%) | 7/17 (41.2%) | 6/17 (35.3%) |
| Combination 3: Cohort 3: Niraparib + Abiraterone Acetate, FDC1-LS | 2/17 (11.8%) | 3/17 (17.6%) | 5/17 (29.4%) |
| Event | Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg | Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg | Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg | Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg | Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone | Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA | Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) | Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) | Combination 3: Cohort 3: Niraparib + Abiraterone Acetate, FDC1-LS |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pulmonary EmbolismRespiratory, thoracic and mediastinal disorders | 0/6 | 0/6 | 0/21 | 0/11 | 0/8 | 0/9 | 0/6 | 1/1 | 0/17 | 0/17 | 0/17 | 1/17 |
| CachexiaMetabolism and nutrition disorders | 0/6 | 2/6 | 0/21 | 0/11 | 0/8 | 0/9 | 0/6 | 0/1 | 0/17 | 0/17 | 0/17 | 0/17 |
| AnaemiaBlood and lymphatic system disorders | 0/6 | 0/6 | 1/21 | 1/11 | 0/8 | 2/9 | 0/6 | 0/1 | 2/17 | 2/17 | 2/17 | 0/17 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/6 | 0/6 | 2/21 | 2/11 | 0/8 | 0/9 | 0/6 | 0/1 | 0/17 | 0/17 | 1/17 | 0/17 |
| Anal FistulaGastrointestinal disorders | 0/6 | 1/6 | 0/21 | 0/11 | 0/8 | 0/9 | 0/6 | 0/1 | 0/17 | 0/17 | 0/17 | 0/17 |
| DiarrhoeaGastrointestinal disorders | 1/6 | 0/6 | 0/21 | 0/11 | 0/8 | 0/9 | 1/6 | 0/1 | 0/17 | 0/17 | 0/17 | 0/17 |
| OesophagitisGastrointestinal disorders | 0/6 | 1/6 | 0/21 | 0/11 | 0/8 | 0/9 | 0/6 | 0/1 | 0/17 | 0/17 | 0/17 | 0/17 |
| UrosepsisInfections and infestations | 0/6 | 0/6 | 0/21 | 0/11 | 0/8 | 0/9 | 1/6 | 0/1 | 0/17 | 0/17 | 1/17 | 0/17 |
| MyositisMusculoskeletal and connective tissue disorders | 0/6 | 1/6 | 0/21 | 0/11 | 0/8 | 0/9 | 0/6 | 0/1 | 0/17 | 0/17 | 0/17 | 0/17 |
| Spinal Cord CompressionNervous system disorders | 1/6 | 0/6 | 1/21 | 0/11 | 0/8 | 0/9 | 0/6 | 0/1 | 0/17 | 0/17 | 2/17 | 0/17 |
| Event | Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg | Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg | Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg | Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg | Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone | Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA | Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) | Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) | Combination 3: Cohort 3: Niraparib + Abiraterone Acetate, FDC1-LS |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 3/6 | 3/6 | 7/21 | 4/11 | 4/8 | 6/9 | 2/6 | 1/1 | 0/17 | 1/17 | 0/17 | 0/17 |
| LymphopeniaBlood and lymphatic system disorders | 0/6 | 0/6 | 5/21 | 4/11 | 1/8 | 0/9 | 0/6 | 1/1 | 0/17 | 0/17 | 0/17 | 0/17 |
| ConstipationGastrointestinal disorders | 2/6 | 2/6 | 13/21 | 3/11 | 3/8 | 6/9 | 3/6 | 1/1 | 2/17 | 1/17 | 1/17 | 2/17 |
| VomitingGastrointestinal disorders | 0/6 | 1/6 | 8/21 | 2/11 | 4/8 | 3/9 | 0/6 | 1/1 | 0/17 | 2/17 | 0/17 | 0/17 |
| FatigueGeneral disorders | 2/6 | 3/6 | 10/21 | 8/11 | 3/8 | 5/9 | 4/6 | 1/1 | 2/17 | 0/17 | 3/17 | 0/17 |
| Decreased AppetiteMetabolism and nutrition disorders | 0/6 | 4/6 | 13/21 | 7/11 | 1/8 | 4/9 | 2/6 | 1/1 | 1/17 | 1/17 | 0/17 | 0/17 |
| Foot DeformityMusculoskeletal and connective tissue disorders | 0/6 | 0/6 | 0/21 | 0/11 | 0/8 | 0/9 | 0/6 | 1/1 | 0/17 | 0/17 | 0/17 | 0/17 |
| Pain in ExtremityMusculoskeletal and connective tissue disorders | 0/6 | 0/6 | 4/21 | 3/11 | 0/8 | 1/9 | 1/6 | 1/1 | 0/17 | 0/17 | 0/17 | 0/17 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/6 | 0/6 | 6/21 | 2/11 | 0/8 | 1/9 | 1/6 | 1/1 | 0/17 | 0/17 | 0/17 | 0/17 |
| PurpuraSkin and subcutaneous tissue disorders | 0/6 | 0/6 | 1/21 | 0/11 | 0/8 | 0/9 | 0/6 | 1/1 | 0/17 | 0/17 | 0/17 | 0/17 |
| Age, Continuous(years) | Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg | Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg | Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg | Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg | Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone | Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA | Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) | Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) | Combination 3: Cohort 3: Niraparib + Abiraterone Acetate, FDC1-LS | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 65.3 ± 7.15 | 66.7 ± 12.56 | 68.1 ± 6.6 | 66.6 ± 3.91 | 71.4 ± 8.23 | 71.3 ± 5.89 | 72.8 ± 9.75 | 80 | 72.3 ± 7.19 | 71.1 ± 7.96 | 71.2 ± 7.85 | 72.9 ± 7.36 | 70.4 ± 7.61 |
| Sex: Female, Male(Participants) | Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg | Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg | Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg | Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg | Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone | Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA | Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) | Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) | Combination 3: Cohort 3: Niraparib + Abiraterone Acetate, FDC1-LS | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Male | 6 | 6 | 21 | 11 | 8 | 9 | 6 | 1 | 17 | 17 | 17 | 17 | 136 |
| Race/Ethnicity, Customized(Participants) | Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg | Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg | Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg | Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg | Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone | Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA | Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) | Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) | Combination 3: Cohort 3: Niraparib + Abiraterone Acetate, FDC1-LS | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 |
| Black or African American | 0 | 0 | 0 | 2 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 1 |
| White | 5 | 6 | 21 | 8 | 7 | 9 | 5 | 0 | 14 | 14 | 16 | 16 | 121 |
| More than one race | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 1 | 1 | 7 |
| Region of Enrollment(Participants) | Combination 1: Part 1 (Dose Seletion): Niraparib 200 mg + Cetrelimab 240 mg | Combination 1: Part 1 (Dose Selection): Niraparib 200 mg + Cetrelimab 480 mg | Combination 1: Part 2 (Dose Expansion): Cohort 1A: BM+: Niraparib 200 mg + Cetrelimab 480 mg | Combination 1: Part 2 (Dose Expansion): Cohort 1B: BM-: Niraparib 200 mg + Cetrelimab 480 mg | Combination 2: Cohort 2A: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2C: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2D: Niraparib+Abiraterone Acetate+Prednisone | Combination 2: Cohort 2C: HRR Negative: Niraparib + Abiraterone Acetate + Prednisone | Combination 3: Cohort 1A: Niraparib + Abiraterone Acetate, SA | Combination 3: Cohort 1B: Niraparib + Abiraterone Acetate, FDC1-RS (G010) | Combination 3: Cohort 2: Niraparib + Abiraterone Acetate, FDC2-RS (G012) | Combination 3: Cohort 3: Niraparib + Abiraterone Acetate, FDC1-LS | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| BELGIUM | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 4 | 2 | 4 | 3 | 16 |
| CANADA | 0 | 0 | 3 | 0 | 1 | 4 | 2 | 0 | 2 | 2 | 2 | 0 | 16 |
| ISRAEL | 0 | 0 | 3 | 2 | 0 | 0 | 0 | 0 | 7 | 5 | 2 | 8 | 27 |
| ITALY | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 3 |
| SPAIN | 2 | 4 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 13 |
| UNITED KINGDOM | 3 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 8 |
| UNITED STATES | 1 | 2 | 8 | 8 | 4 | 4 | 3 | 1 | 4 | 8 | 4 | 6 | 53 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2018 to primary completion in Aug 2021, 41 months.
Results were first posted in Nov 2023, 2 years 2 months after primary completion. A results delay was requested in Aug 2022.
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