Prostate Cancer Clinical Trial

A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Be 18 years old at the time the informed consent form is signed
Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate
Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)
Experienced disease progression after having received at least 1 but no more than 2 prior next-generation androgen receptor-targeted therapies, and 1 prior taxane-based chemotherapy, for castration-resistant disease
Have a deleterious mutation in BRCA1/2 or ATM, or molecular evidence of other homologous recombination deficiency

Exclusion Criteria:

Active second malignancy, with the exception of curatively treated non-melanoma skin cancer, carcinoma in situ, or superficial bladder cancer
Prior treatment with any PARP inhibitor, mitoxantrone, cyclophosphamide or any platinum-based chemotherapy
Symptomatic and/or untreated central nervous system metastases
Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of rucaparib

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

277

Study ID:

NCT02952534

Recruitment Status:

Completed

Sponsor:

Clovis Oncology, Inc.

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There are 142 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35294, United States
Mayo Clinc
Phoenix Arizona, 85259, United States
Arizona Oncology Associates
Tucson Arizona, 85704, United States
Alliance Research Centers
Laguna Hills California, 92653, United States
VA Greater Los Angeles Healthcare System
Los Angeles California, 90073, United States
University of Southern California
Los Angeles California, 90211, United States
Stanford University
Palo Alto California, 94305, United States
Sharp Memorial Hospital
San Diego California, 92123, United States
Pacific Hematology Oncology Associates
San Francisco California, 94115, United States
San Francisco VA Health Care System
San Francisco California, 94143, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94158, United States
Redwood Regional Medical Group
Santa Rosa California, 95406, United States
Kaiser Permanente Medical Center (Vallejo)
Vallejo California, 94589, United States
Rocky Mountain Cancer Centers
Aurora Colorado, 80012, United States
Yale School of Medicine
New Haven Connecticut, 06510, United States
4701 Ogletown Stanton Rd.
Newark Delaware, 19713, United States
Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Boca Raton Community Hospital, Inc.
Boca Raton Florida, 33486, United States
Florida Cancer Specialists
Fort Myers Florida, 33980, United States
University of Florida Health Cancer Center
Orlando Florida, 32806, United States
Moffitt Cancer Center
Tampa Florida, 33612, United States
Atlanta Urological Group
Atlanta Georgia, 30312, United States
University of Chicago Comprehensive Cancer Center
Chicago Illinois, 60637, United States
Ochsner Medical Center
New Orleans Louisiana, 70121, United States
University of Maryland Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
Walter Reed Hospital
Bethesda Maryland, 48202, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
VA Ann Arbor Healthcare System
Ann Arbor Michigan, 48105, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Fairview Hospital
Edina Minnesota, 55435, United States
Minnesota Oncology Hematology, P.A.
Minneapolis Minnesota, 55404, United States
Minnesota Veterans Research Institute
Minneapolis Minnesota, 55417, United States
HCA Midwest Division - Kansas City
Kansas City Missouri, 64132, United States
Alegent Health Bergan Mercy Hospital , GU Research Network
Omaha Nebraska, 68130, United States
Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89119, United States
Premier Urology Associates dba/AdvanceMed Research
Lawrenceville New Jersey, 08648, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
Roswell Park
Buffalo New York, 14263, United States
NYU Perlmutter Cancer Center
New York New York, 10016, United States
Memorial Sloan Kettering CC
New York New York, 10065, United States
Weill Cornell Medical College/NewYork-Presbyterian Hospital
New York New York, 10065, United States
Premier Medical Group of the Hudson Valley PC
Poughkeepsie New York, 12301, United States
University of Rochester
Rochester New York, 14642, United States
SUNY Upstate Medical University
Syracuse New York, 13210, United States
Carolina Urology Partners
Concord North Carolina, 28025, United States
The Urology Group
Cincinnati Ohio, 45212, United States
Kettering Cancer Center
Kettering Ohio, 45429, United States
Clinical Research Solutions
Middleburg Heights Ohio, 44130, United States
VA Portland Health Care System
Portland Oregon, 97219, United States
Consultants in Medical Oncology Hematology
Horsham Pennsylvania, 19044, United States
SCRI - Tennessee Oncology
Nashville Tennessee, 37203, United States
Texas Oncology Medical City Dallas
Dallas Texas, 75320, United States
UT Southwestern Medical Center
Dallas Texas, 75390, United States
UT Health Science Center
Houston Texas, 77030, United States
Texas Oncology - Tyler
Tyler Texas, 75702, United States
Virginia Oncology Associates
Norfolk Virginia, 23502, United States
VA Puget Sound
Seattle Washington, 98108, United States
Northern Cancer Insitute, St. Leonards
Saint Leonards New South Wales, 2065, Australia
Royal Hobart Hospital
Hobart Tasmania, 7000, Australia
Peninsula & Southeast Oncology
Frankston Victoria, 3199, Australia
Barwon Health, University Hospital Geelong
Geelong Victoria, 3220, Australia
Cabrini Hospital
Malvern Victoria, 3144, Australia
Southside Cancer Care Centre
Miranda , 2228, Australia
Orange Health Services
Orange , 2800, Australia
St John of God Hospital, Subiaco
Subiaco , 6008, Australia
Riverina Cancer Care Centre
Wagga Wagga , 2650, Australia
ZNA Middelheim
Antwerp , 2020, Belgium
Universitair Ziekenhuis Gent
Gent , B-900, Belgium
AZ Groeninge
Kortrijk , 8500, Belgium
CHU Sart-Tilman
Liège , 4000, Belgium
Equipe de Recherche Clinique, Département d'Oncologie/Hématologie
Liège , 4000, Belgium
AZ DELTA
Roeselare , B-880, Belgium
Juravinski Cancer Centre Hamilton Health Services
Hamilton Ontario, L8V5C, Canada
London Health Science Center - Victoria Hospital
London Ontario, N6A 4, Canada
The Ottawa Hospital
Ottawa Ontario, K1H8L, Canada
Princess Margaret Hospital
Toronto , M5G 2, Canada
Copenhagen University Hospital
Copenhagen , 2100, Denmark
Herlev Hospital
Herlev , 2730, Denmark
Vejle Sygehus
Vejle , 7100, Denmark
Centre François Baclesse
Caen , 14000, France
Centre Georges François Leclerc
Dijon , 21079, France
Clinique Victor Hugo Centre Jean Bernard
Le Mans , 72000, France
Hôpital Privé La Louvière
Lille , 59800, France
Polyclinique de Gentilly (Centre D'Oncologie De Gentilly)
Nancy , 54100, France
Institut Curie
Paris , 75248, France
Hôpital Privé des Côtes d'Armor
Plérin , 22190, France
CRLCC Eugene Marquis
Rennes , 35042, France
Gemeinschaftspraxis fur Hamatologie & Onkologie
Augsburg , 86150, Germany
Charite Universitatsmedizin Berlin
Berlin , 12200, Germany
Universitatsklinikum Carl Gustav Carus
Dresden , 01307, Germany
Universitatsklinikum Dusseldorf
Dusseldorf , 40225, Germany
Urologische Gemeinschaftspraxis
Emmendingen , 79312, Germany
Universitaetsklinikum Hamburg-Eppendorf (UKE)
Hamburg , 20246, Germany
Universitaetsklinikum Heidelberg
Heidelberg , 69120, Germany
Universitatsklinikum Jena
Jena , 07747, Germany
Universitätsklinik Köln
Köln , 50937, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck , 23538, Germany
Medizinischen Fakultät Mannheim der Universität Heidelberg
Mannheim , 68167, Germany
Studienpraxis Urologie
Nürtingen , 72622, Germany
University of Tuebingen
Tuebingen , 72076, Germany
Die Gesundhehitsunion DGU
Wuppertal , 42103, Germany
Cork University Hospital
Cork , T12 D, Ireland
St. Vincent's University Hospital
Dublin , D04T6, Ireland
St James's Hospital
Dublin , D08 N, Ireland
Adelaide & Meath Hospital, Incorporating the National Children's Hospital
Dublin , Dubli, Ireland
Mater Misericordiae University Hospital
Dublin , Dubli, Ireland
Rambam Health Care Campus (RHCC), Rambam Medical Center
Haifa , 31096, Israel
Hadassah University Hospital
Jerusalem , 71120, Israel
Meir Medical Center
Kfar Saba , 44281, Israel
Rabin Medical Center-Beilinson Campus
Petach Tikva , 49414, Israel
Chaim Sheba Medical Center
Ramat Gan , 52621, Israel
The Tel Aviv Sourasky Medical Center (Ichilov Hospital)
Tel Aviv , 64231, Israel
Ospedale San Donato, Azienda USLSUDEST
Arezzo , 52100, Italy
Ospedale Santa Maria delle Croci
Faenza , 48018, Italy
IRCCS Istituto Nazionale dei Tumori (INT)
Milano , 20133, Italy
IEO Instituto Europeo di Oncologia
Milano , 20141, Italy
University of Modena and Reggio Emilia Medical Oncology
Modena , 41124, Italy
Azienda Ospedaliera San Camillo-Forlanini
Rome , 00152, Italy
Azienda Opsedaliera S. Maria di Terni
Terni , 05100, Italy
Santa Chiara Hospital, Dept Medical Oncology
Trento , 38122, Italy
Hospital Universitari Germans Trias i Pujol
Badalona , 08916, Spain
Hospital del Mar, Servicio de Oncología
Barcelona , 08003, Spain
Hospital Clínic i Provincial de Barcelona-Oncology
Barcelona , 08036, Spain
Instituto Catalan de Oncologia
Barcelona , 08908, Spain
Hospital Universitari Germans Trias i Pujol
Barcelona , 08916, Spain
Hospital General Universitario de Guadalajara
Guadalajara , 19002, Spain
Hospital Universitario Lucus Augusti.
Lugo , 27003, Spain
MD Anderson Cancer Center - Madrid
Madrid , 28033, Spain
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain
Hospital 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital Puerta de Hierro-Majadahonda
Madrid , 28222, Spain
Hospital Universitario Central de Asturias
Oviedo , 33011, Spain
Corporacio Sanitaria Parc Tauli
Sabadell , 8208, Spain
Marques de Valdecilla University Hospital (HUMV)
Santander , 39008, Spain
Hospital Universitario Virgen del Rocío
Sevilla , 41013, Spain
Instituto Valenciano de Oncologia IVO
Valencia , 46009, Spain
Wexham Park Hospital
Slough Berkshire, SL2 4, United Kingdom
Mount Vernon Cancer Centre
Northwood England, HA6 2, United Kingdom
Royal Marsden Hospital
Sutton Surrey, SM2 5, United Kingdom
Oxford University Hospitals
Headington , OC3 7, United Kingdom
Royal Liverpool Hospital
Liverpool , L7 8X, United Kingdom
London Health Science Center - Victoria Hospital
London , N6A 4, United Kingdom
Guy's Hospital
London , SE1 9, United Kingdom
Sarah Cannon Research Institutute - UK
London , W1G 6, United Kingdom
Southampton General Hospital
Southampton , SO16 , United Kingdom
Musgrove Park Hospital
Taunton , TA1 5, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Wirral , CH63 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

277

Study ID:

NCT02952534

Recruitment Status:

Completed

Sponsor:


Clovis Oncology, Inc.

How clear is this clinincal trial information?

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