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Trial record 1 of 1 for:    TRITON3
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A Study of Rucaparib Versus Physician's Choice of Therapy in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON3)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02975934
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : December 3, 2019
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 versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.

Condition or disease Intervention/treatment Phase
Metastatic Castration Resistant Prostate Cancer Drug: Rucaparib Drug: Abiraterone acetate or Enzalutamide or Docetaxel Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: TRITON3: A Multicenter, Randomized, Open Label Phase 3 Study of Rucaparib Versus Physician's Choice of Therapy for Patients With Metastatic Castration Resistant Prostate Cancer Associated With Homologous Recombination Deficiency
Actual Study Start Date : June 13, 2017
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : April 2022


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

Active Comparator: Abiraterone acetate or Enzalutamide or Docetaxel
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Drug: Abiraterone acetate or Enzalutamide or Docetaxel
Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
Other Name: Zytiga (abiraterone acetate) or Xtandi (enzalutamide) or Taxotere (docetaxel)




Primary Outcome Measures :
  1. Radiographic Progression-free Survival (rPFS) [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  2. Duration of Response (DOR) [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  3. Time to Prostate Specific Antigen (PSA) Progression [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  4. PSA Response [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  5. Change in Patient-reported Outcome (PRO) [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  6. Clinical Benefit Rate (CBR), defined as the percentage of patients with a complete response (CR), partial response (PR), and stable disease (SD) according to modified RECIST Version 1.1 with no progression in bone per PCWG3 criteria [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  7. Overall Survival [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  8. Trough plasma PK (Cmin) of rucaparib based on sparse sampling [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  9. Number of participants with Adverse Events (AEs) as a measure of safety and tolerability [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
    Composite assessment of treatment-emergent AEs, including laboratory abnormalities, vital sign abnormalities, electrocardiogram (ECG) abnormalities, physical examination abnormalities and ECOG abnormalities



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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 is signed
  • Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate that is metastatic
  • Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)
  • Be eligible for treatment with physician's choice of comparator treatment (abiraterone acetate, enzalutamide or docetaxel)
  • Experienced disease progression after having received 1 prior next generation androgen receptor-targeted therapy for castration-resistant disease
  • Have a deleterious mutation in a BRCA1/2 or ATM gene

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
  • Prior treatment with chemotherapy for metastatic castration-resistant prostate cancer
  • 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 study drug

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): NCT02975934


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

Locations
Hide Hide 148 study locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
United States, Arizona
Mayo Clinic - Arizona Recruiting
Phoenix, Arizona, United States, 85054
Arizona Oncology Associates - USOR Recruiting
Tucson, Arizona, United States, 85704
United States, California
University of Southern California Recruiting
Beverly Hills, California, United States, 90210
Alliance Research Centers Completed
Laguna Hills, California, United States, 92653
VA Greater Los Angeles Healthcare System Recruiting
Los Angeles, California, United States, 90073
San Bernardino Urological Associates Recruiting
San Bernardino, California, United States, 92404
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, 94121
UCSF Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94158
St. Joseph Heritage Healthcare Recruiting
Santa Rosa, California, United States, 95403
Kaiser Permanente, Northern CA Recruiting
Vallejo, California, United States, 94589
United States, Colorado
Rocky Mountain Cancer Centers Recruiting
Aurora, Colorado, United States, 80012
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
United States, Delaware
Medical Oncology Hematology Consultants - USOR Recruiting
Newark, Delaware, United States, 19713
United States, Florida
Boca Raton Community Hospital, Inc. Recruiting
Boca Raton, Florida, United States, 33486
University of Florida Health Cancer Center Recruiting
Orlando, Florida, United States, 32806
United States, Georgia
Atlanta Urological Group Completed
Atlanta, Georgia, United States, 30312
United States, Hawaii
Kaiser Permanente Medical Group Recruiting
Honolulu, Hawaii, United States, 96819
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
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889
Maryland Oncology Hematology P.A. Recruiting
Columbia, Maryland, United States, 21044
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
Minnesota Oncology Hematology, P.A. Recruiting
Minneapolis, Minnesota, United States, 55404
Minnesota Veterans Research Institute Recruiting
Minneapolis, Minnesota, United States, 55417
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
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, 89169
United States, New Jersey
Premier Urology Associates Completed
Lawrenceville, New Jersey, United States, 08648
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
Weill Cornell Medical College Recruiting
New York, New York, United States, 10065
Premier MEdical Group of the Hudson Valley PC Recruiting
Poughkeepsie, New York, United States, 12601
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
University of North Carolina Lineberger Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Carolina Urology Partners Completed
Concord, North Carolina, United States, 28025
Durham VA Medical Center Recruiting
Durham, North Carolina, United States, 27705
United States, Ohio
The Urology Group Recruiting
Cincinnati, Ohio, United States, 45212
Kettering Medical Center Recruiting
Kettering, Ohio, United States, 45429
Clinical Research Solutions Recruiting
Middleburg Heights, Ohio, United States, 44130
United States, Oregon
VA Portland Health Care System Recruiting
Portland, Oregon, United States, 97219
Northwest Cancer Specialist DBA Compass Oncology Recruiting
Portland, Oregon, United States, 97227
Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
United States, Tennessee
Urology Associates Clinical Research Recruiting
Nashville, Tennessee, United States, 37209
United States, Texas
Urology Clinics of North Texas Completed
Dallas, Texas, United States, 75231
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
UT Health Science Center Recruiting
Houston, Texas, United States, 77030
Texas Oncology Cancer Center-Round Rock Recruiting
Round Rock, Texas, United States, 78681
United States, Virginia
Urology of Virginia Recruiting
Virginia Beach, Virginia, United States, 23462
United States, Washington
MultiCare Regional Cancer Center - Gig Harbor Recruiting
Gig Harbor, Washington, United States, 98335
VA Puget Sound HCS Recruiting
Seattle, Washington, United States, 98108
University of Washington Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Australia, New South Wales
Southside Cancer Care Centre Recruiting
Miranda, New South Wales, Australia, 2228
Orange Health Service Recruiting
Orange, New South Wales, Australia, 2800
Northern Cancer Insitute, St. Leonards Recruiting
Saint Leonards, New South Wales, Australia, 2065
Australia, Western Australia
St John of God Hospital, Subiaco Recruiting
Subiaco, Western Australia, Australia, 6008
Australia
Peninsula & Southeast Oncology Recruiting
Frankston, Australia, 3199
Barwon Health, University Hospital Geelong Recruiting
Geelong, Australia, 3220
Royal Hobart Hospital Recruiting
Hobart, Australia, 7000
Riverina Cancer Care Centre Recruiting
Wagga Wagga, Australia, 2650
Belgium
ZNA Middelheim Recruiting
Antwerp, Belgium, 2020
AZ Groeninge Recruiting
Kortrijk, Belgium, 8500
CHU Sart-Tilman Recruiting
Liège, Belgium, 4000
Clinique et Maternité Sainte-Elisabeth Recruiting
Namur, Belgium, 5000
Canada, Alberta
Tom Baker Cancer Centre Recruiting
Calgary, Alberta, Canada, T2N 4N2
Canada, Manitoba
Cancer Care Manitoba Recruiting
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, New Brunswick
Centre Hospitalier Universitaire Dr-Georges-L.-Dumont Recruiting
Moncton, New Brunswick, Canada, E1C 8X3
Canada, Ontario
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 4L6
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada, K1H8L6
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Canada
Lakeridge Health Medical Specialty Medical Oncology Recruiting
Oshawa, Canada, L1G 2B9
Sunnybrook Odette Cancer Centre Recruiting
Toronto, Canada, M4N3M5
Denmark
Copenhagen University Hospital Recruiting
Copenhagen, Denmark, 2100
Herlev Hospital Recruiting
Herlev, Denmark, 2730
Vejle Sygehus Recruiting
Vejle, Denmark, 7100
France
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, 59000
Centre Léon Bérard Recruiting
Lyon, France, 69008
Polyclinique de Gentilly (Centre D'Oncologie De Gentilly) Recruiting
Nancy, France, 54000
Institut Curie Recruiting
Paris, France, 75248
Centre Armoricain de Radiotherapie, Imagerie medicale et Oncologie, CARIO Recruiting
Plérin, France, 22190
CRLCC Eugene Marquis Recruiting
Rennes, France, 35042
Institut Gustave-Roussy Recruiting
Villejuif, France, 94805
Germany
Gemeinschaftspraxis für Hämatologie&Onkologie Recruiting
Augsburg, Germany, 86150
Charite - Universitaetsmedizin Berlin Recruiting
Berlin, Germany, 12200
Apotheke des Städtischen Klinikums Braunschweig Recruiting
Braunschweig, Germany, 38102
University Hospital Carl Gustav Carus Recruiting
Dresden, Germany, 01307
Universitatsklinikum Dusseldorf Recruiting
Dusseldorf, Germany, 40225
Urologische Gemeinschaftspraxis Recruiting
Emmendingen, Germany, 79312
Universitaetsklinikum Hamburg-Eppendorf (UKE) Completed
Hamburg, Germany, 20246
Universitatsklinikum Jena Recruiting
Jena, Germany, 07747
Universitätsklinikum Köln Recruiting
Köln, Germany, 50937
Universitätsklinikum Schleswig-Holstein Recruiting
Lubeck, Germany, 23538
Medizinischen Fakultät Mannheim der Universität Heidelberg Recruiting
Mannheim, Germany, 68167
Studienpraxis Urologie Recruiting
Nurtingen, Germany, 72622
University of Tuebingen Recruiting
Tuebingen, Germany, 72076
Die GesundheitsUnion (DGU) Recruiting
Wuppertal, Germany, 42103
Ireland
Cork University Hospital Recruiting
Cork, Ireland
Adelaide & Meath Hospital, Incorporating the National Children's Hospital Recruiting
Dublin, Ireland
Mater Misericordiae University Hospital Recruiting
Dublin, Ireland
Mater Private Hospital (MPH) Recruiting
Dublin, Ireland
St James's Hospital Recruiting
Dublin, Ireland
St. Vincent's University Hospital Recruiting
Dublin, Ireland
Israel
Rambam Health Care Campus (RHCC), Rambam Medical Center Recruiting
Haifa, Israel, 3109601
Hadassah University Hospital Recruiting
Jerusalem, Israel, 91120
Meir Medical Center Recruiting
Kfar Saba, Israel, 4428164
Rabin Medical Center-Beilinson Campus Recruiting
Petach Tikva, Israel, 4941492
The Tel Aviv Sourasky Medical Center (Ichilov Hospital) Recruiting
Tel Aviv, Israel, 6423
Chaim Sheba Medical Center Recruiting
Tel Hashomer, Israel, 5262000
Italy
Ospedale San Donato, Azienda USLSUDEST Recruiting
Arezzo, Italy, 52100
Ospedale Santa Maria delle Croci Recruiting
Faenza, Italy, 48018
Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica Recruiting
Meldola, Italy, 47014
IEO Instituto Europeo di Oncologia Recruiting
Milano, Italy, 20141
University of Modena and Reggio Emilia Recruiting
Modena, Italy, 41124
Azienda Ospedaliera San Camillo-Forlanini Recruiting
Roma, Italy, 00152
Azienda Opsedaliera S. Maria di Terni Recruiting
Terni, Italy, 05100
Presidio Ospedaliero Santa Chiara di Trento Recruiting
Trento, Italy, 38122
Spain
Hospital Universitari Germans Trias i Pujol Recruiting
Barcelona, Spain, 08916
Hospital Universitario Reina Sofia Recruiting
Córdoba, Spain, 14004
Hospital General Universitario de Guadalajara Recruiting
Guadalajara, Spain, 19002
Hospital Universitario Lucus Augusti. Recruiting
Lugo, Spain, 27004
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 Clinico Universitario Virgen de la Victoria Recruiting
Málaga, Spain, 29010
Hospital Universitario Central de Asturias Recruiting
Oviedo, Spain, 33011
Corporacio Sanitaria Parc Tauli Recruiting
Sabadell, Spain, 08208
Marques de Valdecilla University Hospital (HUMV) Recruiting
Santander, Spain, 39008
Hospital Universitario Virgen del Rocío Recruiting
Sevilla, Spain, 41013
Instituto Valenciano de Oncología Recruiting
Valencia, Spain, 46009
United Kingdom
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, England, United Kingdom, SE1 9RT
Royal Marsden Hospital Recruiting
London, England, United Kingdom, SM2 5PT
Oxford Cancer Centre, Medical Oncology Unit Recruiting
Oxford, England, United Kingdom, OX3 7LE
Royal Preston Hospital Recruiting
Preston, England, United Kingdom, PR2 9HT
Wexham Park Hospital Recruiting
Slough, England, United Kingdom, SL2 4HL
Velindre Hospital Recruiting
Cardiff, United Kingdom, CF14 2TL
Royal Marsden Hospital Recruiting
London, United Kingdom, SM2 5PT
Musgrove Park Hospital Recruiting
Taunton, United Kingdom, TA15DA
The Clatterbridge Cancer Centre NHS Foundation Trust Recruiting
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: NCT02975934    
Other Study ID Numbers: CO-338-063
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: December 3, 2019
Last Verified: December 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.:
CRPC
PARP inhibitor
PARPi
BRCA
ATM
HRD
TRITON
homologous recombination
DNA repair
DNA defect
DNA anomaly
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
Docetaxel
Abiraterone Acetate
Rucaparib
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 Enzyme Inhibitors
Poly(ADP-ribose) Polymerase Inhibitors