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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002694-35 | EudraCT Number | ||
| 64091742PCR1001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of this study is to assess the safety and pharmacokinetics of niraparib when administered in combination with an androgen receptor (AR)-targeted therapy (apalutamide or abiraterone acetate plus prednisone) in adult men with metastatic castration resistant prostate cancer (mCRPC) who may or may not have deoxyribonucleic acid (DNA)-repair anomalies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niraparib + Apalutamide/[Abiraterone Acetate + Prednisone] | Experimental | Participants will receive initial starting dose of Niraparib 200 milligram (mg) once daily in combination either with Apalutamide 240 mg (4*60 mg) once daily or Abiraterone Acetate 1000 mg (4*250 mg) plus 10 mg Prednisone (5 mg twice daily) for 28 days of cycle 1. Once a safe dose of niraparib is selected with each Andrgen Receptor (AR)-targeted therapy [Apalutamide or Abiraterone Acetate plus Prednisone], then an expansion phase (Part 2) will open to further explore safety and assess antitumor activity. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niraparib | Drug | Participants will start with niraparib 200 mg once daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Determine Recommended Phase 2 dose (RP2D) of Niraparib in Combination With 240 milligram (mg) Apalutamide or 1,000 mg Abiraterone Acetate Plus 10 mg Prednisone (5 mg Twice Daily) in Part 1 | RP2D will be defined as the highest dose of study drug at which less than 33 percent (%) of participants experience dose limiting toxicity (DLT). | Up to 56 days |
| Number of Participants With Incidence and Severity of Adverse Events (Part 2) | Number of participants will be assessed to further explore safety and antitumor activity in Part 2 (dose expansion) of study. | Up to 30 days after last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Maximum observed plasma concentration (Cmax) will be assessed. | 24 hours postdose on Cycle 1 Day 1 up to 10 hours postdose Cycle 3 Day 1 (each cycle 28 days) |
| Time to Reach the Maximum Observed Plasma Concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Hollywood | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33754187 | Derived | Saad F, Chi KN, Shore ND, Graff JN, Posadas EM, Lattouf JB, Espina BM, Zhu E, Yu A, Hazra A, De Meulder M, Mamidi RNVS, Bradic B, Francis P, Hayreh V, Rezazadeh Kalebasty A. Niraparib with androgen receptor-axis-targeted therapy in patients with metastatic castration-resistant prostate cancer: safety and pharmacokinetic results from a phase 1b study (BEDIVERE). Cancer Chemother Pharmacol. 2021 Jul;88(1):25-37. doi: 10.1007/s00280-021-04249-7. Epub 2021 Mar 22. |
| Label | URL |
|---|---|
| A Safety and Pharmacokinetics Study of Niraparib plus Androgen Receptor-Targeted Therapy (Apalutamide or Abiraterone Acetate plus Prednisone) in Men with Metastatic Castration-Resistant | View source |
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| Apalutamide | Drug | Participants will receive apalutamide 240 mg (4*60 mg) once daily orally. |
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| Abiraterone Acetate | Drug | Participants will receive 1000 mg (4*250mg) once daily. |
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| Prednisone | Drug | Participants will receive 10 mg (1*5 mg twice daily). |
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Time to reach the maximum plasma concentration(Tmax) will be assessed. |
| 24 hours postdose on Cycle 1 Day 1 up to 10 hours postdose Cycle 3 Day 1 (each cycle 28 days) |
| Area Under the Plasma Concentration-Time Curve From Time Zero to 24 Hours (AUC [0-24]) | Area under plasma concentration-time curve from time 0 to time 24 hours after dosing will be assessed. | 24 hours postdose on Cycle 1 Day 1 up to 10 hours postdose Cycle 3 Day 1 (each cycle 28 days) |
| Trough Plasma Concentration (Ctrough) | Ctrough is the minimum observed (that is, predose) plasma concentration following multiple dosing will be assessed. | Predose (Cycle 1 Days 15 and 22) up to Cycle 3 Day 1 (each cycle 28 days) then Every 3 Cycles after Cycle 3 till End of Treatment (30 days after last dose) |
| Metabolite to Parent Ratio for Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC [0-24]) | Metabolite to parent drug ratio for area under the plasma concentration-time curve from time 0 to 24 hours (AUC [0-24]) will be assessed. | 24 hours postdose on Cycle 1 Day 1 up to 10 hours postdose Cycle 3 Day 1 (each cycle 28 days) |
| Louisville |
| Kentucky |
| United States |
| Portland | Oregon | United States |
| Myrtle Beach | South Carolina | United States |
| Vancouver | British Columbia | Canada |
| Montreal | Quebec | Canada |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C545685 | niraparib |
| C572045 | apalutamide |
| D000069501 | Abiraterone Acetate |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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