A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON2)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02952534 |
Recruitment Status :
Active, not recruiting
First Posted : November 2, 2016
Last Update Posted : November 27, 2020
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Castration Resistant Prostate Cancer | Drug: Rucaparib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 360 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | February 15, 2017 |
Estimated Primary Completion Date : | June 2021 |
Estimated Study Completion Date : | June 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Rucaparib
Oral rucaparib (monotherapy)
|
Drug: Rucaparib
Rucaparib will be administered daily
Other Name: CO-338 |
- Objective Response Rate (ORR) [ Time Frame: From enrollment to primary completion of study (up to approximately 3 years) ]
- Prostate Specific Antigen (PSA) Response [ Time Frame: From enrollment to primary completion of study (up to approximately 3 years) ]
- Duration of Response (DOR) [ Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months) ]
- Radiologic Progression-free Survival (rPFS) [ Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months) ]
- Overall Survival (OS) [ Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months) ]
- 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) ]
- Time to PSA Progression [ Time Frame: From enrollment to primary completion of study (up to approximately 3 years) ]
- 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) ]
- 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) ]This is a composite outcome. It will be assessed by incidence, type, seriousness, and severity of AEs reported; clinical laboratory investigations (hematology, serum chemistry and urinalysis); Vital signs (blood pressure, heart rate, and body temperature); 12 lead ECGs; Physical examinations; and ECOG performance status

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 | |
Wexham Park Hospital | |
Slough, Berkshire, United Kingdom, SL2 4HL | |
Mount Vernon Cancer Centre | |
Northwood, England, United Kingdom, HA6 2RN | |
Royal Marsden Hospital | |
Sutton, Surrey, United Kingdom, SM2 5PT | |
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 |
Responsible Party: | Clovis Oncology, Inc. |
ClinicalTrials.gov Identifier: | NCT02952534 |
Other Study ID Numbers: |
CO-338-052 |
First Posted: | November 2, 2016 Key Record Dates |
Last Update Posted: | November 27, 2020 |
Last Verified: | November 2020 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
CRPC PARP inhibitor PARPi BRCA ATM HRD TRITON homologous recombination DNA repair DNA defect DNA anomaly BARD1 BRIP1 |
CDK12 CHEK2 FANCA NBN PALB2 RAD51 RAD51B RAD51C RAD51D RAD54L germline somatic mCRPC |
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases |
Rucaparib Poly(ADP-ribose) Polymerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |