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

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ClinicalTrials.gov Identifier: NCT02952534
Recruitment Status : Recruiting
First Posted : November 2, 2016
Last Update Posted : June 4, 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.

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
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

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


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
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 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

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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    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 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
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