Clinical Trial - NCT02952534

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

Active, not recruiting

Sponsor: Clovis Oncology, Inc.

Collaborators: Foundation Medicine

Information provided by (Responsible party): Sponsor Identifier: NCT02952534

Protocol Info

Short Description: Rucaparib In Castration-Resistant Prostate Cancer
Long Description: TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients with Metastatic Castration-resistant Prostate Cancer Associated with Homologous Recombination Deficiency
MGH Status: Closed
Sponsor: Clovis Oncology, Inc.
Disease Program: GU

Next Steps

If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.


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.
Condition Title Intervention Phase
Metastatic Castration Resistant Prostate Cancer Rucaparib Phase 2
Study Type Interventional
Official Title TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency

Primary Outcome Measures

Objective Response Rate (ORR) [Time Frame: From enrollment to primary completion of study (up to approximately 3 years)] [Designated as safety issue: ]

Prostate Specific Antigen (PSA) Response [Time Frame: From enrollment to primary completion of study (up to approximately 3 years)] [Designated as safety issue: ]

Secondary Outcome Measures

Duration of Response (DOR) [Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months)] [Designated as safety issue: ]

Radiologic Progression-free Survival (rPFS) [Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months)] [Designated as safety issue: ]

Overall Survival (OS) [Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months)] [Designated as safety issue: ]

Clinical Benefit Rate (CBR), defined as the percentage of patients with a complete response (CR), partial response (PR) or stable disease (SD) according to modified RECIST 1.1 with no progression in bone per PCWG3 criteria [Time Frame: From enrollment to primary completion of study (up to approximately 3 years)] [Designated as safety issue: ]

Time to PSA Progression [Time Frame: From enrollment to primary completion of study (up to approximately 3 years)] [Designated as safety issue: ]

Trough plasma PK (Cmin) of rucaparib based on sparse sampling [Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months)] [Designated as safety issue: ]

Safety and tolerability of rucaparib assessed by AEs reported; clinical laboratory investigations; Vital signs; 12-lead ECGs; Physical examinations; and ECOG performance status [Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months)] [Designated as safety issue: ]

Estimated Enrollment: 360
Study Start Date: February 2017
Estimated Study Completion Date: February 2021
Estimated Primary Completion Date: September 2020
Arms Assigned Interventions


Oral rucaparib (monotherapy)
Rucaparib will be administered daily


Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: Male

Accepts Healthly Volunteers: No

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

Contacts and Locations

Please refer to this study by its identifier: NCT02952534


  • United States, Alabama
    • University of Alabama at Birmingham Birmingham, Alabama, United States, 35294
  • United States, Arizona
    • Mayo Clinc Phoenix, Arizona, United States, 85259
    • Arizona Oncology Associates Tucson, Arizona, United States, 85704
  • United States, California
    • Alliance Research Centers Laguna Hills, California, United States, 92653
    • VA Greater Los Angeles Healthcare System Los Angeles, California, United States, 90073
    • University of Southern California Los Angeles, California, United States, 90211
    • Stanford University Palo Alto, California, United States, 94305
    • Sharp Memorial Hospital San Diego, California, United States, 92123
    • Pacific Hematology Oncology Associates San Francisco, California, United States, 94115
    • San Francisco VA Health Care System San Francisco, California, United States, 94143
    • UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California, United States, 94158
    • Redwood Regional Medical Group Santa Rosa, California, United States, 95406
    • Kaiser Permanente Medical Center (Vallejo) Vallejo, California, United States, 94589
  • United States, Colorado
    • Rocky Mountain Cancer Centers Aurora, Colorado, United States, 80012
  • United States, Connecticut
    • Yale School of Medicine New Haven, Connecticut, United States, 06510
  • United States, Delaware
    • 4701 Ogletown Stanton Rd. Newark, Delaware, United States, 19713
  • United States, District of Columbia
    • Georgetown University Medical Center Washington, District of Columbia, United States, 20007
  • United States, Florida
    • Boca Raton Community Hospital, Inc. Boca Raton, Florida, United States, 33486
    • Florida Cancer Specialists Fort Myers, Florida, United States, 33980
    • University of Florida Health Cancer Center Orlando, Florida, United States, 32806
    • Moffitt Cancer Center Tampa, Florida, United States, 33612
  • United States, Georgia
    • Atlanta Urological Group Atlanta, Georgia, United States, 30312
  • United States, Illinois
    • University of Chicago Comprehensive Cancer Center Chicago, Illinois, United States, 60637
  • United States, Louisiana
    • Ochsner Medical Center New Orleans, Louisiana, United States, 70121
  • United States, Maryland
    • University of Maryland Greenebaum Cancer Center Baltimore, Maryland, United States, 21201
    • Walter Reed Hospital Bethesda, Maryland, United States, 48202
  • United States, Massachusetts
    • Massachusetts General Hospital Boston, Massachusetts, United States, 02114
  • United States, Michigan
    • VA Ann Arbor Healthcare System Ann Arbor, Michigan, United States, 48105
    • Henry Ford Hospital Detroit, Michigan, United States, 48202
  • United States, Minnesota
    • Fairview Hospital Edina, Minnesota, United States, 55435
    • Minnesota Oncology Hematology, P.A. Minneapolis, Minnesota, United States, 55404
    • Minnesota Veterans Research Institute Minneapolis, Minnesota, United States, 55417
  • United States, Missouri
    • HCA Midwest Division - Kansas City Kansas City, Missouri, United States, 64132
  • United States, Nebraska
    • Alegent Health Bergan Mercy Hospital , GU Research Network Omaha, Nebraska, United States, 68130
    • Nebraska Cancer Specialists Omaha, Nebraska, United States, 68130
  • United States, Nevada
    • Comprehensive Cancer Centers of Nevada Las Vegas, Nevada, United States, 89119
  • United States, New Jersey
    • Premier Urology Associates dba/AdvanceMed Research Lawrenceville, New Jersey, United States, 08648
    • Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey, United States, 08901
  • United States, New York
    • Roswell Park Buffalo, New York, United States, 14263
    • NYU Perlmutter Cancer Center New York, New York, United States, 10016
    • Memorial Sloan Kettering CC New York, New York, United States, 10065
    • Weill Cornell Medical College/NewYork-Presbyterian Hospital New York, New York, United States, 10065
    • Premier Medical Group of the Hudson Valley PC Poughkeepsie, New York, United States, 12301
    • University of Rochester Rochester, New York, United States, 14642
    • SUNY Upstate Medical University Syracuse, New York, United States, 13210
  • United States, North Carolina
    • Carolina Urology Partners Concord, North Carolina, United States, 28025
  • United States, Ohio
    • The Urology Group Cincinnati, Ohio, United States, 45212
    • Kettering Cancer Center Kettering, Ohio, United States, 45429
    • Clinical Research Solutions Middleburg Heights, Ohio, United States, 44130
  • United States, Oregon
    • VA Portland Health Care System Portland, Oregon, United States, 97219
  • United States, Pennsylvania
    • Consultants in Medical Oncology Hematology Horsham, Pennsylvania, United States, 19044
  • United States, Tennessee
    • SCRI - Tennessee Oncology Nashville, Tennessee, United States, 37203
  • United States, Texas
    • Texas Oncology Medical City Dallas Dallas, Texas, United States, 75320
    • UT Southwestern Medical Center Dallas, Texas, United States, 75390
    • UT Health Science Center Houston, Texas, United States, 77030
    • Texas Oncology - Tyler Tyler, Texas, United States, 75702
  • United States, Virginia
    • Virginia Oncology Associates Norfolk, Virginia, United States, 23502
  • United States, Washington
    • VA Puget Sound Seattle, Washington, United States, 98108
  • Australia, New South Wales
    • Northern Cancer Insitute, St. Leonards Saint Leonards, New South Wales, Australia, 2065
  • Australia, Tasmania
    • Royal Hobart Hospital Hobart, Tasmania, Australia, 7000
  • Australia, Victoria
    • Peninsula & Southeast Oncology Frankston, Victoria, Australia, 3199
    • Barwon Health, University Hospital Geelong Geelong, Victoria, Australia, 3220
    • Cabrini Hospital Malvern, Victoria, Australia, 3144
  • Australia,
    • Southside Cancer Care Centre Miranda, , Australia, 2228
    • Orange Health Services Orange, , Australia, 2800
    • St John of God Hospital, Subiaco Subiaco, , Australia, 6008
    • Riverina Cancer Care Centre Wagga Wagga, , Australia, 2650
  • Belgium,
    • ZNA Middelheim Antwerp, , Belgium, 2020
    • Universitair Ziekenhuis Gent Gent, , Belgium, B-9000
    • AZ Groeninge Kortrijk, , Belgium, 8500
    • CHU Sart-Tilman Liège, , Belgium, 4000
    • Equipe de Recherche Clinique, Département d'Oncologie/Hématologie Liège, , Belgium, 4000
    • AZ DELTA Roeselare, , Belgium, B-8800
  • Canada, Ontario
    • Juravinski Cancer Centre Hamilton Health Services Hamilton, Ontario, Canada, L8V5C2
    • London Health Science Center - Victoria Hospital London, Ontario, Canada, N6A 4L6
    • The Ottawa Hospital Ottawa, Ontario, Canada, K1H8L6
  • Canada,
    • Princess Margaret Hospital Toronto, , Canada, M5G 2M9
  • Denmark,
    • Copenhagen University Hospital Copenhagen, , Denmark, 2100
    • Herlev Hospital Herlev, , Denmark, 2730
    • Vejle Sygehus Vejle, , Denmark, 7100
  • France,
    • Centre François Baclesse Caen, , France, 14000
    • Centre Georges François Leclerc Dijon, , France, 21079
    • Clinique Victor Hugo Centre Jean Bernard Le Mans, , France, 72000
    • Hôpital Privé La Louvière Lille, , France, 59800
    • Polyclinique de Gentilly (Centre D'Oncologie De Gentilly) Nancy, , France, 54100
    • Institut Curie Paris, , France, 75248
    • Hôpital Privé des Côtes d'Armor Plérin, , France, 22190
    • CRLCC Eugene Marquis Rennes, , France, 35042
  • Germany,
    • Gemeinschaftspraxis fur Hamatologie & Onkologie Augsburg, , Germany, 86150
    • Charite Universitatsmedizin Berlin Berlin, , Germany, 12200
    • Universitatsklinikum Carl Gustav Carus Dresden, , Germany, 01307
    • Universitatsklinikum Dusseldorf Dusseldorf, , Germany, 40225
    • Urologische Gemeinschaftspraxis Emmendingen, , Germany, 79312
    • Universitaetsklinikum Hamburg-Eppendorf (UKE) Hamburg, , Germany, 20246
    • Universitaetsklinikum Heidelberg Heidelberg, , Germany, 69120
    • Universitatsklinikum Jena Jena, , Germany, 07747
    • Universitätsklinik Köln Köln, , Germany, 50937
    • Universitätsklinikum Schleswig-Holstein Lübeck, , Germany, 23538
    • Medizinischen Fakultät Mannheim der Universität Heidelberg Mannheim, , Germany, 68167
    • Studienpraxis Urologie Nürtingen, , Germany, 72622
    • University of Tuebingen Tuebingen, , Germany, 72076
    • Die Gesundhehitsunion DGU Wuppertal, , Germany, 42103
  • Ireland,
    • Cork University Hospital Cork, , Ireland, T12 DFK4
    • St. Vincent's University Hospital Dublin, , Ireland, D04T6F4
    • St James's Hospital Dublin, , Ireland, D08 NHY1
    • Adelaide & Meath Hospital, Incorporating the National Children's Hospital Dublin, , Ireland, Dublin 24
    • Mater Misericordiae University Hospital Dublin, , Ireland, Dublin 7
  • Israel,
    • Rambam Health Care Campus (RHCC), Rambam Medical Center Haifa, , Israel, 3109601
    • Hadassah University Hospital Jerusalem, , Israel, 71120
    • Meir Medical Center Kfar Saba, , Israel, 4428164
    • Rabin Medical Center-Beilinson Campus Petach Tikva, , Israel, 4941492
    • Chaim Sheba Medical Center Ramat Gan, , Israel, 52621
    • The Tel Aviv Sourasky Medical Center (Ichilov Hospital) Tel Aviv, , Israel, 64231
  • Italy,
    • Ospedale San Donato, Azienda USLSUDEST Arezzo, , Italy, 52100
    • Ospedale Santa Maria delle Croci Faenza, , Italy, 48018
    • IRCCS Istituto Nazionale dei Tumori (INT) Milano, , Italy, 20133
    • IEO Instituto Europeo di Oncologia Milano, , Italy, 20141
    • University of Modena and Reggio Emilia Medical Oncology Modena, , Italy, 41124
    • Azienda Ospedaliera San Camillo-Forlanini Rome, , Italy, 00152
    • Azienda Opsedaliera S. Maria di Terni Terni, , Italy, 05100
    • Santa Chiara Hospital, Dept Medical Oncology Trento, , Italy, 38122
  • Spain,
    • Hospital Universitari Germans Trias i Pujol Badalona, , Spain, 08916
    • Hospital del Mar, Servicio de Oncología Barcelona, , Spain, 08003
    • Hospital Clínic i Provincial de Barcelona-Oncology Barcelona, , Spain, 08036
    • Instituto Catalan de Oncologia Barcelona, , Spain, 08908
    • Hospital Universitari Germans Trias i Pujol Barcelona, , Spain, 08916
    • Hospital General Universitario de Guadalajara Guadalajara, , Spain, 19002
    • Hospital Universitario Lucus Augusti. Lugo, , Spain, 27003
    • MD Anderson Cancer Center - Madrid Madrid, , Spain, 28033
    • Hospital Universitario Ramón y Cajal Madrid, , Spain, 28034
    • Hospital 12 de Octubre Madrid, , Spain, 28041
    • Hospital Universitario La Paz Madrid, , Spain, 28046
    • Hospital Puerta de Hierro-Majadahonda Madrid, , Spain, 28222
    • Hospital Universitario Central de Asturias Oviedo, , Spain, 33011
    • Corporacio Sanitaria Parc Tauli Sabadell, , Spain, 8208
    • Marques de Valdecilla University Hospital (HUMV) Santander, , Spain, 39008
    • Hospital Universitario Virgen del Rocío Sevilla, , Spain, 41013
    • Instituto Valenciano de Oncologia IVO Valencia, , Spain, 46009
  • United Kingdom, Berkshire
    • Wexham Park Hospital Slough, Berkshire, United Kingdom, SL2 4HL
  • United Kingdom, England
    • Mount Vernon Cancer Centre Northwood, England, United Kingdom, HA6 2RN
  • United Kingdom, Surrey
    • Royal Marsden Hospital Sutton, Surrey, United Kingdom, SM2 5PT
  • United Kingdom,
    • Oxford University Hospitals Headington, , United Kingdom, OC3 7LJ
    • Royal Liverpool Hospital Liverpool, , United Kingdom, L7 8XP
    • London Health Science Center - Victoria Hospital London, , United Kingdom, N6A 4L6
    • Guy's Hospital London, , United Kingdom, SE1 9RT
    • Sarah Cannon Research Institutute - UK London, , United Kingdom, W1G 6AD
    • Southampton General Hospital Southampton, , United Kingdom, SO16 6YD
    • Musgrove Park Hospital Taunton, , United Kingdom, TA1 5DA
    • The Clatterbridge Cancer Centre NHS Foundation Trust Wirral, , United Kingdom, CH63 4JY

Sponsors and Collaborators

Clovis Oncology, Inc.

Foundation Medicine

More Information

No publications provided

Responsible Party: Sponsor Identifier: NCT02952534
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

Keywords provided by Clovis Oncology, Inc.:


PARP inhibitor






homologous recombination

DNA repair

DNA defect

DNA anomaly
















Additional relevant MeSH terms:

Prostatic Neoplasms


Next Steps

If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation. processed this data on September 03, 2020