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NCT03431350 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Prostatic Neoplasms, Castration-Resistant, sponsored by Janssen Research & Development.

Active
Registry status
Phase 2
Development phase
136
Enrollment target
20
Study locations

NCT03431350: Active Phase 2 study of Prostatic Neoplasms, Castration-Resistant, sponsored by Janssen Research & Development.

NCT03431350 is a Phase 2 study of Prostatic Neoplasms, Castration-Resistant that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 136 participants, below the 727-participant average among 10 other Prostatic Neoplasms, Castration-Resistant trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03431350, a Phase 2 study of Prostatic Neoplasms, Castration-Resistant, is active but no longer recruiting, sponsored by Janssen Research & Development.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
136 participants
Enrollment target
20
Study locations

Study 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).

Primary Outcome

Number of participants with specified toxicity during Cycle 1 was reported. Only toxicities that occurred during safety evaluation period(defined as first 28 days of treatment-Cycle 1 of Part 1) was used for analysis of specified toxicities and for dose reduction decisions. Toxicities were graded for severity as per NCI-CTCAE, version 4.03. Safety evaluation criteria were: Any Grade(G) \>=3 non-hematological toxicity without anorexia, or constipation, fatigue improved to G\<=2 in \<7 days, vomit

Conditions Studied

Prostatic Neoplasms, Castration-Resistant

Interventions

  • DRUG Prednisone 5 mg
  • DRUG Niraparib 200 mg
  • DRUG Cetrelimab 240 mg
  • DRUG Cetrelimab 480 mg
  • DRUG Abiraterone acetate 1000 mg

Study Locations (20)

New York

  • New York Oncology Hematology - Albany
  • Memorial Sloan Kettering Cancer Center - Harrison
  • Memorial Sloan Kettering Cancer Center - New York

Pennsylvania

  • Thomas Jefferson University - Philadelphia
  • University of Pittsburgh Medical Center (UPMC) - Pittsburgh

South Carolina

  • MUSC-Hollings Cancer Center - Charleston
  • Carolina Urologic Research Center - Myrtle Beach

Texas

  • Houston Metro Urology - Houston
  • The University of Texas MD Anderson Cancer Center - Houston

Arizona

  • Urological Associates of Southern Arizona, P.C. - Tucson

Colorado

  • The Urology Center of Colorado - Denver

Florida

  • Mayo Clinic - Division Of Hematology/oncology - Jacksonville

Indiana

  • First Urology, PSC - Jeffersonville

Trial Details

FieldValue
Enrollment Target 136 participants
Start Date 2018-03-02
Est. Completion 2025-12-31
Phase Phase 2
Janssen Research & Development

593 total trials

What the registry record for NCT03431350 still lists

NCT03431350 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 727-participant average among 10 other Prostatic Neoplasms, Castration-Resistant trials with a reported enrollment target (81% lower).

The record links to 1 condition, with Prostatic Neoplasms, Castration-Resistant appearing as the primary indexed condition, and to 5 interventions - of which Prednisone 5 mg is the first listed.

NCT03431350 names 20 study sites across 15 states, led by New York, Pennsylvania, South Carolina.

Frequently Asked Questions

What is clinical trial NCT03431350 about?

NCT03431350 is a clinical study titled "A Study of Niraparib Combination Therapies for the Treatment of Metastatic Castration-Resistant Prostate Cancer". 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 (Com...

What is the current status of trial NCT03431350?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 136 participants. The study started on 2018-03-02. Estimated completion is 2025-12-31.

What conditions does trial NCT03431350 study?

This clinical trial studies the following conditions: Prostatic Neoplasms, Castration-Resistant.

What interventions are being tested in trial NCT03431350?

The interventions under investigation include: Prednisone 5 mg (DRUG), Niraparib 200 mg (DRUG), Cetrelimab 240 mg (DRUG), Cetrelimab 480 mg (DRUG), Abiraterone acetate 1000 mg (DRUG).

Who is sponsoring clinical trial NCT03431350?

This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03431350 being conducted?

This trial has 20 study locations across Arizona, Colorado, Florida, Indiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Prostatic Neoplasms, Castration-Resistant

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03431350's enrollment target sits among peer trials

136 6th of 10 higher than 5 of 10 other Prostatic Neoplasms, Castration-Resistant trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prostatic Neoplasms, Castration-Resistant trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03431350, the US trial registry maintained by the National Library of Medicine. NCT03431350 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.