TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency


Condition: Metastatic Castration Resistant Prostate Cancer

Intervention:

  • Drug: Rucaparib

Purpose: 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.

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02952534

Sponsor: Clovis Oncology, Inc.

Primary Outcome Measures:

  • Measure: Objective Response Rate (ORR)
  • Time Frame: From enrollment to primary completion of study (up to approximately 3 years)
  • Safety Issue:
  • Measure: Prostate Specific Antigen (PSA) Response
  • Time Frame: From enrollment to primary completion of study (up to approximately 3 years)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Duration of Response (DOR)
  • Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months)
  • Safety Issue:
  • Measure: Radiologic Progression-free Survival (rPFS)
  • Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months)
  • Safety Issue:
  • Measure: Overall Survival (OS)
  • Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months)
  • Safety Issue:
  • Measure: 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)
  • Safety Issue:
  • Measure: Time to PSA Progression
  • Time Frame: From enrollment to primary completion of study (up to approximately 3 years)
  • Safety Issue:
  • Measure: 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)
  • Safety Issue:
  • Measure: 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)
  • Safety Issue:

Estimated Enrollment: 360

Study Start Date: February 15, 2017

Phase: Phase 2

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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

Contact:

  • Clovis Oncology Clinical Trial Navigation Service
  • 1-855-262-3040 (USA)

Locations:

  • University of Alabama at Birmingham
  • Birmingham Alabama 35294 United States
  • Mayo Clinc
  • Phoenix Arizona 85259 United States
  • Arizona Oncology Associates
  • Tucson Arizona 85704 United States
  • Alliance Research Centers
  • Laguna Hills California 92653 United States
  • VA Greater Los Angeles Healthcare System
  • Los Angeles California 90073 United States
  • University of Southern California
  • Los Angeles California 90211 United States
  • Stanford University
  • Palo Alto California 94305 United States
  • Sharp Memorial Hospital
  • San Diego California 92123 United States
  • Pacific Hematology Oncology Associates
  • San Francisco California 94115 United States
  • San Francisco VA Health Care System
  • San Francisco California 94143 United States
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • San Francisco California 94158 United States
  • Redwood Regional Medical Group
  • Santa Rosa California 95406 United States
  • Kaiser Permanente Medical Center (Vallejo)
  • Vallejo California 94589 United States
  • Rocky Mountain Cancer Centers
  • Aurora Colorado 80012 United States
  • Yale School of Medicine
  • New Haven Connecticut 06510 United States
  • 4701 Ogletown Stanton Rd.
  • Newark Delaware 19713 United States
  • Georgetown University Medical Center
  • Washington District of Columbia 20007 United States
  • Boca Raton Community Hospital, Inc.
  • Boca Raton Florida 33486 United States
  • Florida Cancer Specialists
  • Fort Myers Florida 33980 United States
  • University of Florida Health Cancer Center
  • Orlando Florida 32806 United States
  • Moffitt Cancer Center
  • Tampa Florida 33612 United States
  • Atlanta Urological Group
  • Atlanta Georgia 30312 United States
  • University of Chicago Comprehensive Cancer Center
  • Chicago Illinois 60637 United States
  • Ochsner Medical Center
  • New Orleans Louisiana 70121 United States
  • University of Maryland Greenebaum Cancer Center
  • Baltimore Maryland 21201 United States
  • Henry Ford Hospital
  • Bethesda Maryland 48202 United States
  • Massachusetts General Hospital
  • Boston Massachusetts 02114 United States
  • VA Ann Arbor Healthcare System
  • Ann Arbor Michigan 48105 United States
  • Henry Ford Hospital
  • Detroit Michigan 48202 United States
  • Fairview Hospital
  • Edina Minnesota 55435 United States
  • Minnesota Oncology Hematology, P.A.
  • Minneapolis Minnesota 55404 United States
  • Minnesota Veterans Research Institute
  • Minneapolis Minnesota 55417 United States
  • HCA Midwest Division - Kansas City
  • Kansas City Missouri 64132 United States
  • Alegent Health Bergan Mercy Hospital , GU Research Network
  • Omaha Nebraska 68130 United States
  • Nebraska Cancer Specialists
  • Omaha Nebraska 68130 United States
  • Comprehensive Cancer Centers of Nevada
  • Las Vegas Nevada 89119 United States
  • Premier Urology Associates dba/AdvanceMed Research
  • Lawrenceville New Jersey 08648 United States
  • Rutgers Cancer Institute of New Jersey
  • New Brunswick New Jersey 08901 United States
  • Roswell Park
  • Buffalo New York 14263 United States
  • NYU Perlmutter Cancer Center
  • New York New York 10016 United States
  • Memorial Sloan Kettering CC
  • New York New York 10065 United States
  • Premier Medical Group of the Hudson Valley PC
  • Poughkeepsie New York 12301 United States
  • University of Rochester
  • Rochester New York 14642 United States
  • SUNY Upstate Medical University
  • Syracuse New York 13210 United States
  • Carolina Urology Partners
  • Concord North Carolina 28025 United States
  • The Urology Group
  • Cincinnati Ohio 45212 United States
  • Clinical Research Solutions
  • Middleburg Heights Ohio 44130 United States
  • VA Portland Health Care System
  • Portland Oregon 97219 United States
  • SCRI - Tennessee Oncology
  • Nashville Tennessee 37203 United States
  • Texas Oncology Medical City Dallas
  • Dallas Texas 75320 United States
  • UT Southwestern Medical Center
  • Dallas Texas 75390 United States
  • UT Health Science Center
  • Houston Texas 77030 United States
  • Texas Oncology - Tyler
  • Tyler Texas 75702 United States
  • Virginia Oncology Associates
  • Norfolk Virginia 23502 United States
  • VA Puget Sound
  • Seattle Washington 98108 United States
  • Northern Cancer Insitute, St. Leonards
  • Saint Leonards New South Wales 2065 Australia
  • Royal Hobart Hospital
  • Hobart Tasmania 7000 Australia
  • Peninsula & Southeast Oncology
  • Frankston Victoria 3199 Australia
  • Barwon Health, University Hospital Geelong
  • Geelong Victoria 3220 Australia
  • Cabrini Hospital
  • Malvern Victoria 3144 Australia
  • Southside Cancer Care Centre
  • Miranda 2228 Australia
  • Orange Health Services
  • Orange 2800 Australia
  • St John of God Hospital, Subiaco
  • Subiaco 6008 Australia
  • Riverina Cancer Care Centre
  • Wagga Wagga 2650 Australia
  • ZNA Middelheim
  • Antwerp 2020 Belgium
  • Universitair Ziekenhuis Gent
  • Gent B-9000 Belgium
  • AZ Groeninge
  • Kortrijk 8500 Belgium
  • CHU Sart-Tilman
  • Liège 4000 Belgium
  • Equipe de Recherche Clinique, Département d'Oncologie/Hématologie
  • Liège 4000 Belgium
  • AZ DELTA
  • Roeselare B-8800 Belgium
  • Juravinski Cancer Centre Hamilton Health Services
  • Hamilton Ontario L8V5C2 Canada
  • London Health Science Center - Victoria Hospital
  • London Ontario N6A 4L6 Canada
  • The Ottawa Hospital
  • Ottawa Ontario K1H8L6 Canada
  • Princess Margaret Hospital
  • Toronto M5G 2M9 Canada
  • Copenhagen University Hospital
  • Copenhagen 2100 Denmark
  • Herlev Hospital
  • Herlev 2730 Denmark
  • Vejle Sygehus
  • Vejle 7100 Denmark
  • Centre François Baclesse
  • Caen 14000 France
  • Centre Georges François Leclerc
  • Dijon 21079 France
  • Clinique Victor Hugo Centre Jean Bernard
  • Le Mans 72000 France
  • Hôpital Privé La Louvière
  • Lille 59800 France
  • Polyclinique de Gentilly (Centre D'Oncologie De Gentilly)
  • Nancy 54100 France
  • Institut Curie
  • Paris 75248 France
  • Hôpital Privé des Côtes d'Armor
  • Plérin 22190 France
  • CRLCC Eugene Marquis
  • Rennes 35042 France
  • Gemeinschaftspraxis fur Hamatologie & Onkologie
  • Augsburg 86150 Germany
  • Charite Universitatsmedizin Berlin
  • Berlin 12200 Germany
  • Universitatsklinikum Carl Gustav Carus
  • Dresden 01307 Germany
  • Universitatsklinikum Dusseldorf
  • Dusseldorf 40225 Germany
  • Urologische Gemeinschaftspraxis
  • Emmendingen 79312 Germany
  • Universitaetsklinikum Hamburg-Eppendorf (UKE)
  • Hamburg 20246 Germany
  • Universitaetsklinikum Heidelberg
  • Heidelberg 69120 Germany
  • Universitatsklinikum Jena
  • Jena 07747 Germany
  • Universitätsklinik Köln
  • Köln 50937 Germany
  • Universitätsklinikum Schleswig-Holstein
  • Lübeck 23538 Germany
  • Medizinischen Fakultät Mannheim der Universität Heidelberg
  • Mannheim 68167 Germany
  • Studienpraxis Urologie
  • Nürtingen 72622 Germany
  • University of Tuebingen
  • Tuebingen 72076 Germany
  • Die Gesundhehitsunion DGU
  • Wuppertal 42103 Germany
  • Cork University Hospital
  • Cork T12 DFK4 Ireland
  • St. Vincent's University Hospital
  • Dublin D04T6F4 Ireland
  • St James's Hospital
  • Dublin D08 NHY1 Ireland
  • Adelaide & Meath Hospital, Incorporating the National Children's Hospital
  • Dublin Dublin 24 Ireland
  • Mater Misericordiae University Hospital
  • Dublin Dublin 7 Ireland
  • Rambam Health Care Campus (RHCC), Rambam Medical Center
  • Haifa 3109601 Israel
  • Hadassah University Hospital
  • Jerusalem 71120 Israel
  • Meir Medical Center
  • Kfar Saba 4428164 Israel
  • Rabin Medical Center-Beilinson Campus
  • Petach Tikva 4941492 Israel
  • Chaim Sheba Medical Center
  • Ramat Gan 52621 Israel
  • The Tel Aviv Sourasky Medical Center (Ichilov Hospital)
  • Tel Aviv 64231 Israel
  • Ospedale San Donato, Azienda USLSUDEST
  • Arezzo 52100 Italy
  • Ospedale Santa Maria delle Croci
  • Faenza 48018 Italy
  • IRCCS Istituto Nazionale dei Tumori (INT)
  • Milano 20133 Italy
  • IEO Instituto Europeo di Oncologia
  • Milano 20141 Italy
  • University of Modena and Reggio Emilia Medical Oncology
  • Modena 41124 Italy
  • Azienda Ospedaliera San Camillo-Forlanini
  • Rome 00152 Italy
  • Azienda Opsedaliera S. Maria di Terni
  • Terni 05100 Italy
  • Santa Chiara Hospital, Dept Medical Oncology
  • Trento 38122 Italy
  • Hospital Universitari Germans Trias i Pujol
  • Badalona 08916 Spain
  • Hospital del Mar, Servicio de Oncología
  • Barcelona 08003 Spain
  • Hospital Clínic i Provincial de Barcelona-Oncology
  • Barcelona 08036 Spain
  • Instituto Catalan de Oncologia
  • Barcelona 08908 Spain
  • Hospital Universitari Germans Trias i Pujol
  • Barcelona 08916 Spain
  • Hospital General Universitario de Guadalajara
  • Guadalajara 19002 Spain
  • Hospital Universitario Lucus Augusti.
  • Lugo 27003 Spain
  • MD Anderson Cancer Center - Madrid
  • Madrid 28033 Spain
  • Hospital Universitario Ramón y Cajal
  • Madrid 28034 Spain
  • Hospital 12 de Octubre
  • Madrid 28041 Spain
  • Hospital Universitario La Paz
  • Madrid 28046 Spain
  • Hospital Puerta de Hierro-Majadahonda
  • Madrid 28222 Spain
  • Hospital Universitario Central de Asturias
  • Oviedo 33011 Spain
  • Corporacio Sanitaria Parc Tauli
  • Sabadell 8208 Spain
  • Marques de Valdecilla University Hospital (HUMV)
  • Santander 39008 Spain
  • Hospital Universitario Virgen del Rocío
  • Sevilla 41013 Spain
  • Instituto Valenciano de Oncologia IVO
  • Valencia 46009 Spain
  • Wexham Park Hospital
  • Slough Berkshire SL2 4HL United Kingdom
  • Mount Vernon Cancer Centre
  • Northwood England HA6 2RN United Kingdom
  • Royal Marsden Hospital
  • Sutton Surrey SM2 5PT United Kingdom
  • Oxford University Hospitals
  • Headington OC3 7LJ United Kingdom
  • Royal Liverpool Hospital
  • Liverpool L7 8XP United Kingdom
  • London Health Science Center - Victoria Hospital
  • London N6A 4L6 United Kingdom
  • Guy's Hospital
  • London SE1 9RT United Kingdom
  • Sarah Cannon Research Institutute - UK
  • London W1G 6AD United Kingdom
  • Southampton General Hospital
  • Southampton SO16 6YD United Kingdom
  • Musgrove Park Hospital
  • Taunton TA1 5DA United Kingdom
  • The Clatterbridge Cancer Centre NHS Foundation Trust
  • Wirral CH63 4JY United Kingdom

View trial on ClinicalTrials.gov


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