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

• ClinicalTrials.gov Identifier: NCT02952534
• Recruitment Status: Recruiting
• First Posted: November 2, 2016
• Last Update Posted: October 1, 2019
• 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

• 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

• 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

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

  Hide Study Locations

Locations

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

Arizona Oncology Associates; Recruiting

Tucson, Arizona, United States, 85704

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; Completed

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; Completed

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

Nebraska Cancer Specialists; Recruiting

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

Texas Oncology Medical City Dallas; Recruiting

Dallas, Texas, United States, 75320

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

Universitatsklinikum Dusseldorf; Recruiting

Dusseldorf, Germany, 40225

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 General Universitario de Guadalajara; Recruiting

Guadalajara, Spain, 19002

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; Completed

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

• 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: October 1, 2019
• Last Verified: September 2019

• 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:

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