drugset / Trial / NCT03431350
A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Non-randomizedSequentialOpen-labelTreatment
Summary
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).
Timeline
- Start
- 2018-03-02
- Primary completion
- 2021-08-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | 1000 mg | Oral |
| Subject | Cetrelimab | Monoclonal antibody | 240 mg | Intravenous |
| Subject | Cetrelimab | Monoclonal antibody | 480 mg | Intravenous |
| Subject | Niraparib | Small molecule | 200 mg | Oral |
| Subject | Prednisone | Other / unclassified | 5 mg | Oral |