NCT03431350

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

A Phase 1b-2 Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This multicenter study will evaluate safety and efficacy of niraparib in combination with other anti-cancer agents. Combination 1 will combine niraparib with the anti-programmed cell death protein (PD)-1 monoclonal antibody cetrelimab, in participants with mCRPC. Combination 1 has 2 parts: in Part 1 (dose selection), participants will be enrolled to establish RP2D doses of niraparib and cetrelimab; and Part 2 (dose expansion) will evaluate the combination therapy in an expanded number of participants into 2 cohorts (biomarker positive or biomarker negative). Combination 2 will combine niraparib with abiraterone acetate plus prednisone (AA-P) in mCRPC participants with DNA-repair gene defects (DRD). Combination 3 will evaluate the relative bioavailability (BA) of niraparib and AA in combination. In a pharmacokinetics (PK) assessment phase, niraparib and AA will be administered, and in an extension phase, niraparib and AA-P will be administered. Combinations 1 and 2 will have 5 phases: A Pre-screening Phase, a Screening Phase, a Treatment Phase, a Follow-up Phase, and a Long-term Extension (LTE) Phase; Combination 3 has 3 phases: A Screening Phase, A PK Assessment Phase, an Extension Phase (including LTE phase). Study evaluations will include efficacy, PK, PK/pharmacodynamics, biomarkers, safety and tolerability.

Conditions

• Prostatic Neoplasms, Castration-Resistant

Interventions

Type	Name	Description
DRUG	Niraparib 200 mg	Participants will receive niraparib 200 mg orally.
DRUG	Cetrelimab 240 mg	Participants will receive cetrelimab 240 mg IV every 2 weeks.
DRUG	Cetrelimab 480 mg	Participants will receive cetrelimab 480 mg IV every 4 weeks.
DRUG	Abiraterone acetate 1000 mg	Participants will receive AA 1000 mg orally.
DRUG	Prednisone 5 mg	Participants will receive prednisone 5 mg orally.

Timeline

• Start date: 2018-03-02
• Primary completion: 2021-08-31
• Completion: 2026-12-31
• First posted: 2018-02-13
• Last updated: 2026-04-13
• Results posted: 2023-11-18

Locations

50 sites across 7 countries: United States, Belgium, Canada, Israel, Italy, Spain, United Kingdom

Regulatory

• FDA-regulated drug study