A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- pharmaand GmbH
- Study ID
- NCT02952534
- Phase
- PHASE2
- Status
- Completed
Conditions
- Metastatic Castration Resistant Prostate Cancer
Eligibility Criteria
- Sex
- MALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Rucaparib — DRUGRucaparib will be administered daily
Study Details
The purpose of this study is to determine how patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib.
Key Dates
- Start date
- Feb 15, 2017
- Status verified
- Jun 2023
- Primary completion
- Jul 18, 2021
- Completion
- Jul 27, 2021
Study Design
- Enrollment
- 277 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: RucaparibOral rucaparib (monotherapy)
Primary Outcome Measure
Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Central Independent Radiology Review (IRR) [ Time Frame: Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years. ]
Locations (58)
Find similar trials in Birmingham, AL
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