MedTrace Logo

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

NCT03431350 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2026-05-11

Study results available
· View outcomes & findings →

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).

Conditions

  • Prostatic Neoplasms, Castration-Resistant

Interventions

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.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-02
Primary Completion
2021-08-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Israel
  • Italy
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03431350 on ClinicalTrials.gov