Last updated on December 2019

A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

---

Brief description of study

The purpose of this study is to establish the recommended phase 2 dose (RP2D) of niraparib combination therapies of Part 1 and to evaluate the antitumor activity and safety of niraparib combination therapies of Part 2.

Detailed Study Description

This multicenter study will evaluate safety and efficacy of niraparib in combination with other anti-cancer agents. Two combinations are being studied: the first combination study will combine niraparib with the anti-programmed cell death protein (PD)-1 monoclonal antibody, JNJ-63723283 in participants with metastatic castration-resistant prostate cancer (mCRPC). The second combination will combine niraparib with abiraterone acetate plus prednisone (AA-P) in mCRPC participants with DNA-repair gene defects (DRD). Combination 1 has 2 parts: in Part 1 (dose selection), participants will be enrolled to explore 2 doses of niraparib and JNJ-63723283; and Part 2 (dose expansion) will evaluate the combination therapy in an expanded number of participants. In Part 2, participants will be enrolled into 2 cohorts based on biomarker status. Combination 2 has only 1 part (Part 2) and no Part 1. In Part 2, participants will be enrolled into 4 cohorts (breast cancer gene [BRCA] biallelic loss [2A], other DRD biallelic loss [2B], BRCA monoallelic loss [2C], and other DRD monoallelic loss [2D]). Each combination in the study will have 4 phases: A Prescreening Phase, a Screening Phase, a Treatment Phase, and a Follow-up Phase. Study evaluations will include efficacy, pharmacokinetic (PK), PK/pharmacodynamics, biomarkers, safety and tolerability.