Trials / Completed
CompletedNCT02924766
A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)
A Safety and Pharmacokinetics Study of Niraparib Plus Androgen Receptor-Targeted Therapy (Apalutamide or Abiraterone Acetate Plus Prednisone) in Men With Metastatic Castration-Resistant Prostate Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 34 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Niraparib | Participants will start with niraparib 200 mg once daily. |
| DRUG | Apalutamide | Participants will receive apalutamide 240 mg (4\*60 mg) once daily orally. |
| DRUG | Abiraterone Acetate | Participants will receive 1000 mg (4\*250mg) once daily. |
| DRUG | Prednisone | Participants will receive 10 mg (1\*5 mg twice daily). |
Timeline
- Start date
- 2016-10-03
- Primary completion
- 2019-07-18
- Completion
- 2019-07-19
- First posted
- 2016-10-05
- Last updated
- 2020-07-20
Locations
6 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT02924766. Inclusion in this directory is not an endorsement.