A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON2)

• Sponsor: Clovis Oncology, Inc.
• Collaborator: Foundation Medicine
• Information provided by (Responsible Party): Clovis Oncology, Inc.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Metastatic Castration Resistant Prostate Cancer	Drug: Rucaparib	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	360 participants
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 :	October 2019
Estimated Study Completion Date :	April 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Rucaparib; Oral rucaparib (monotherapy)	Drug: Rucaparib; Rucaparib will be administered daily; Other Name: CO-338

Outcome Measures

Primary Outcome Measures :

1. Objective Response Rate (ORR) [ Time Frame: From enrollment to primary completion of study (up to approximately 3 years) ]
2. Prostate Specific Antigen (PSA) Response [ Time Frame: From enrollment to primary completion of study (up to approximately 3 years) ]

Secondary Outcome Measures :

1. Duration of Response (DOR) [ Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months) ]
2. Radiologic Progression-free Survival (rPFS) [ Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months) ]
3. Overall Survival (OS) [ Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months) ]
4. 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) ]
5. Time to PSA Progression [ Time Frame: From enrollment to primary completion of study (up to approximately 3 years) ]
6. 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) ]
7. 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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Contacts

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Contact: Clovis Oncology Clinical Trial Navigation Service	1-855-262-3040 (USA)	clovistrials@emergingmed.com
Contact: Clovis Oncology Clinical Trial Navigation Service	1-303-625-5160 (ex-USA)	clovistrials@emergingmed.com

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Locations

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

Sponsors and Collaborators

Clovis Oncology, Inc.

Foundation Medicine

More Information

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Responsible Party:	Clovis Oncology, Inc.
ClinicalTrials.gov Identifier:	NCT02952534 History of Changes
Other Study ID Numbers:	CO-338-052
First Posted:	November 2, 2016
Last Update Posted:	April 29, 2019
Last Verified:	April 2019

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Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Keywords provided by Clovis Oncology, Inc.:

TRITON; CHEK2; PALB2; CRPC; PARP inhibitor; PARPi; BRCA; ATM; HRD; homologous recombination; DNA repair; DNA defect; DNA anomaly	BARD1; BRIP1; CDK12; FANCA; NBN; RAD51; RAD51B; RAD51C; RAD51D; RAD54L; germline; somatic; mCRPC

Additional relevant MeSH terms:

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Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases	Genital Diseases, Male; Rucaparib; Poly(ADP-ribose) Polymerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents