At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 289 enrolled
Drug / intervention
Niraparibdrug
Likely dose
Niraparib 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies
In Brief
A Phase 2 clinical trial evaluating Niraparib for Prostatic Neoplasms. Completed, enrolled 289 participants across 110 sites in 15 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstatic Neoplasms
CountriesAustralia, Belgium, Brazil, Canada, Denmark, France, Israel, Netherlands, Russia, South Korea, Spain, Sweden, Taiwan, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartAug 2016
Primary CompletionJan 2021
Study CompletionAug 2023
TodayJul 2026
First PostedAug 3, 2016
Enrollment StartAug 31, 2016
Primary CompletionJan 26, 2021
Study CompletionAug 16, 2023
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 9.9 years ago
Interventions
Niraparibdrug
Participants will receive 300 mg niraparib (3 capsules\*100 mg) orally once daily.