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 — DRUG
    Rucaparib 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: Rucaparib
    Oral 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)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Mayo ClincPhoenixArizona85259-
Arizona Oncology AssociatesTucsonArizona85704-
Alliance Research CentersLaguna HillsCalifornia92653-
University of Southern CaliforniaLos AngelesCalifornia90211-
VA Greater Los Angeles Healthcare SystemLos AngelesCalifornia90073-
Stanford UniversityPalo AltoCalifornia94305-
Sharp Memorial HospitalSan DiegoCalifornia92123-
Pacific Hematology Oncology AssociatesSan FranciscoCalifornia94115-
San Francisco VA Health Care SystemSan FranciscoCalifornia94143-
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94158-
Redwood Regional Medical GroupSanta RosaCalifornia95406-
Kaiser Permanente Medical Center (Vallejo)VallejoCalifornia94589-
Rocky Mountain Cancer CentersAuroraColorado80012-
Yale School of MedicineNew HavenConnecticut06510-
4701 Ogletown Stanton Rd.NewarkDelaware19713-
Georgetown University Medical CenterWashington D.C.District of Columbia20007-
Boca Raton Community Hospital, Inc.Boca RatonFlorida33486-
Florida Cancer SpecialistsFort MyersFlorida33980-
University of Florida Health Cancer CenterOrlandoFlorida32806-
Moffitt Cancer CenterTampaFlorida33612-
Atlanta Urological GroupAtlantaGeorgia30312-
University of Chicago Comprehensive Cancer CenterChicagoIllinois60637-
Ochsner Medical CenterNew OrleansLouisiana70121-
University of Maryland Greenebaum Cancer CenterBaltimoreMaryland21201-
Walter Reed HospitalBethesdaMaryland48202-
Massachusetts General HospitalBostonMassachusetts02114-
VA Ann Arbor Healthcare SystemAnn ArborMichigan48105-
Henry Ford HospitalDetroitMichigan48202-
Fairview HospitalEdinaMinnesota55435-
Minnesota Oncology Hematology, P.A.MinneapolisMinnesota55404-
Minnesota Veterans Research InstituteMinneapolisMinnesota55417-
HCA Midwest Division - Kansas CityKansas CityMissouri64132-
Alegent Health Bergan Mercy Hospital , GU Research NetworkOmahaNebraska68130-
Nebraska Cancer SpecialistsOmahaNebraska68130-
Comprehensive Cancer Centers of NevadaLas VegasNevada89119-
Premier Urology Associates dba/AdvanceMed ResearchLawrencevilleNew Jersey08648-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Roswell ParkBuffaloNew York14263-
Memorial Sloan Kettering CCNew YorkNew York10065-
NYU Perlmutter Cancer CenterNew YorkNew York10016-
Weill Cornell Medical College/NewYork-Presbyterian HospitalNew YorkNew York10065-
Premier Medical Group of the Hudson Valley PCPoughkeepsieNew York12301-
University of RochesterRochesterNew York14642-
SUNY Upstate Medical UniversitySyracuseNew York13210-
Carolina Urology PartnersConcordNorth Carolina28025-
The Urology GroupCincinnatiOhio45212-
Kettering Cancer CenterKetteringOhio45429-
Clinical Research SolutionsMiddleburg HeightsOhio44130-
VA Portland Health Care SystemPortlandOregon97219-
Consultants in Medical Oncology HematologyHorshamPennsylvania19044-
SCRI - Tennessee OncologyNashvilleTennessee37203-
Texas Oncology Medical City DallasDallasTexas75320-
UT Southwestern Medical CenterDallasTexas75390-
UT Health Science CenterHoustonTexas77030-
Texas Oncology - TylerTylerTexas75702-
Virginia Oncology AssociatesNorfolkVirginia23502-
VA Puget SoundSeattleWashington98108-

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