An Efficacy and Safety Study of Niraparib in Men With Metastatic Castration-Resistant Prostate Cancer and DNA-Repair Anomalies

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT02854436
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    Participants will receive 300 mg niraparib (3 capsules\*100 mg) orally once daily.

Study Details

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.

Key Dates

Start date
Aug 31, 2016
Status verified
Dec 2025
Primary completion
Jan 26, 2021
Completion
Aug 16, 2023

Study Design

Enrollment
289 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Niraparib
    Participants will receive 300 milligram (mg) niraparib (3 capsules\*100 mg) orally once daily.

Primary Outcome Measure

Objective Response Rate (ORR) for Participants With Measurable Metastatic Castration-resistant Prostate Cancer (mCRPC) and Breast Cancer Gene (BRCA) Mutation [ Time Frame: Up to 52 months ]

Locations (23)

FacilityCityStateZIPSite coordinators
-TucsonArizona--
-Los AngelesCalifornia--
-RiversideCalifornia--
-SacramentoCalifornia--
-AuroraColorado--
-DenverColorado--
-EvanstonIllinois--
-DanvilleKentucky--
-LouisvilleKentucky--
-New OrleansLouisiana--
-BostonMassachusetts--
-DetroitMichigan--
-OmahaNebraska--
-New YorkNew York--
-DurhamNorth Carolina--
-LancasterPennsylvania--
-PhiladelphiaPennsylvania--
-Myrtle BeachSouth Carolina--
-HoustonTexas--
-CharlottesvilleVirginia--
-FairfaxVirginia--
-SeattleWashington--
-MadisonWisconsin--

Find similar trials in Tucson, AZ

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology

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