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NCT02854436 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 289
- Enrollment target
NCT02854436: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT02854436 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 289 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (117% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02854436, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 289 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies.
Primary Outcome
ORR defined as percentage of participants with BRCA DNA-repair anomalies and measurable disease whose best response is either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and with no evidence of bone progression per Prostate Cancer Working Group 3 (PCWG3) criteria.
Interventions
- DRUG Niraparib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 289 participants |
| Start Date | 2016-08-31 |
| Est. Completion | 2023-08-16 |
| Phase | Phase 2 |
What the finished NCT02854436 record still lists
NCT02854436 is an interventional study that assigns participants to a tested intervention. The registered 289 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (117% higher).
The record links to 0 conditions, and to 1 intervention - of which Niraparib is the first listed.
NCT02854436 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02854436 about?
NCT02854436 is a clinical study titled "An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies". The purpose of this study is to assess the efficacy, safety, and pharmacokinetics of niraparib in men with metastatic castration-resistant prostate cancer (mCRPC) and deoxyribonucleic acid (DNA) repair anomalies.
What is the current status of trial NCT02854436?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 289 participants. The study started on 2016-08-31. Estimated completion is 2023-08-16.
What interventions are being tested in trial NCT02854436?
The interventions under investigation include: Niraparib (DRUG).
Who is sponsoring clinical trial NCT02854436?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02854436's enrollment target sits among peer trials
289 191st of 2000 higher than 1,810 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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