Last updated on February 2020

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. Combination 1 is being studied that will combine niraparib with the anti-programmed cell death protein (PD)-1 monoclonal antibody, cetrelimab in participants with metastatic castration-resistant prostate cancer (mCRPC). Combination 1 has 2 parts: in Part 1 (dose selection), participants will be enrolled to explore 2 doses of niraparib and cetrelimab; and Part 2 (dose expansion) will evaluate the combination therapy in an expanded number of participants (who are either BM+ or BM- for DRD or BM+ for CDK12). In Part 2, participants will be enrolled into 2 cohorts based on biomarker status. 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.

Clinical Study Identifier: NCT03431350

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Michigan Institute of Urology

Troy, MI United States
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