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

• ClinicalTrials.gov Identifier: NCT02952534
• Recruitment Status: Active, not recruiting
• First Posted: November 2, 2016
• Last Update Posted: August 3, 2020
• 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
• 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: September 2020
• Estimated Study Completion Date: February 2021

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

Locations

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

Sponsors and Collaborators

Clovis Oncology, Inc.

Foundation Medicine

More Information

• Responsible Party: Clovis Oncology, Inc.
• ClinicalTrials.gov Identifier: NCT02952534
• Other Study ID Numbers: CO-338-052
• First Posted: November 2, 2016
• Last Update Posted: August 3, 2020
• Last Verified: July 2020

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

Keywords provided by Clovis Oncology, Inc.:

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

Additional relevant MeSH terms:

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