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

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 : August 3, 2020
Sponsor:
Collaborator:
Foundation Medicine
Information provided by (Responsible Party):
Clovis Oncology, Inc.

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Rucaparib

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




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



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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

Information from the National Library of Medicine

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


Locations
Hide Hide 149 study locations
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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
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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: August 3, 2020
Last Verified: July 2020

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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.:
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:
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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