Clinical Trial - NCT02975934

       

A Study of Rucaparib Versus Physician's Choice of Therapy in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

Recruiting

Sponsor: Clovis Oncology, Inc.

Collaborators: Foundation Medicine

Information provided by (Responsible party): Sponsor

ClinicalTrials.gov Identifier: NCT02975934

Protocol Info

Short Description: Rucaparib Vs Physician's Choice in Prostate Cancer
Long Description: 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
MGH Status: Open
Sponsor: Clovis Oncology, Inc.
Disease Program: GU

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.




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 versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.
Condition Title Intervention Phase
Metastatic Castration Resistant Prostate Cancer Rucaparib Abiraterone acetate or Enzalutamide or Docetaxel Phase 3
Study Type Interventional
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

Primary Outcome Measures

Radiographic Progression-free Survival (rPFS) [Time Frame: From enrollment to primary completion of study (up to approximately 5 years)] [Designated as safety issue: ]


Secondary Outcome Measures

Objective Response Rate (ORR) [Time Frame: From enrollment to primary completion of study (up to approximately 5 years)] [Designated as safety issue: ]

Duration of Response (DOR) [Time Frame: From enrollment to primary completion of study (up to approximately 5 years)] [Designated as safety issue: ]

Time to Prostate Specific Antigen (PSA) Progression [Time Frame: From enrollment to primary completion of study (up to approximately 5 years)] [Designated as safety issue: ]

PSA Response [Time Frame: From enrollment to primary completion of study (up to approximately 5 years)] [Designated as safety issue: ]

Change in Patient-reported Outcome (PRO) [Time Frame: From enrollment to primary completion of study (up to approximately 5 years)] [Designated as safety issue: ]

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)] [Designated as safety issue: ]

Overall Survival [Time Frame: From enrollment to primary completion of study (up to approximately 5 years)] [Designated as safety issue: ]

Trough plasma PK (Cmin) of rucaparib based on sparse sampling [Time Frame: From enrollment to primary completion of study (up to approximately 5 years)] [Designated as safety issue: ]

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)] [Designated as safety issue: ]

Estimated Enrollment: 400
Study Start Date: June 2017
Estimated Study Completion Date: April 2022
Estimated Primary Completion Date: February 2022
Arms Assigned Interventions

Experimental:Rucaparib

Oral rucaparib (monotherapy).
Drug:Rucaparib
Rucaparib will be administered daily.

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.

Eligibility

Ages Eligible for Study: N/A-N/A

Genders Eligible for Study: Male

Accepts Healthly Volunteers: No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02975934

Locations

  • United States, Alabama
    • University of Alabama at Birmingham Birmingham, Alabama, United States, 35233
  • United States, Arizona
    • Mayo Clinic - Arizona Phoenix, Arizona, United States, 85054
    • Arizona Oncology Associates - USOR Tucson, Arizona, United States, 85704
  • United States, California
    • University of Southern California Beverly Hills, California, United States, 90210
    • Alliance Research Centers Laguna Hills, California, United States, 92653
    • VA Greater Los Angeles Healthcare System Los Angeles, California, United States, 90073
    • San Bernardino Urological Associates San Bernardino, California, United States, 92404
    • 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, 94121
    • UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California, United States, 94158
    • St. Joseph Heritage Healthcare Santa Rosa, California, United States, 95403
    • Kaiser Permanente, Northern CA Vallejo, California, United States, 94589
  • United States, Colorado
    • Rocky Mountain Cancer Centers Aurora, Colorado, United States, 80012
  • United States, Connecticut
    • Yale University School of Medicine New Haven, Connecticut, United States, 06510
  • United States, Delaware
    • Medical Oncology Hematology Consultants - USOR Newark, Delaware, United States, 19713
  • United States, Florida
    • Boca Raton Community Hospital, Inc. Boca Raton, Florida, United States, 33486
    • University of Florida Health Cancer Center Orlando, Florida, United States, 32806
  • United States, Georgia
    • Atlanta Urological Group Atlanta, Georgia, United States, 30312
  • United States, Hawaii
    • Kaiser Permanente Medical Group Honolulu, Hawaii, United States, 96819
  • 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 National Military Medical Center Bethesda, Maryland, United States, 20889
    • Maryland Oncology Hematology P.A. Columbia, Maryland, United States, 21044
  • 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
    • Minnesota Oncology Hematology, P.A. Minneapolis, Minnesota, United States, 55404
    • Minnesota Veterans Research Institute Minneapolis, Minnesota, United States, 55417
    • University of Minnesota Minneapolis, Minnesota, United States, 55455
    • Mayo Clinic - Rochester, MN Rochester, Minnesota, United States, 55902
  • 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, 89169
  • United States, New Jersey
    • Premier Urology Associates Lawrenceville, New Jersey, United States, 08648
  • 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 New York, New York, United States, 10065
    • Premier MEdical Group of the Hudson Valley PC Poughkeepsie, New York, United States, 12601
    • University of Rochester Rochester, New York, United States, 14642
    • SUNY Upstate Medical University Syracuse, New York, United States, 13210
  • United States, North Carolina
    • University of North Carolina Lineberger Cancer Center Chapel Hill, North Carolina, United States, 27599
    • Carolina Urology Partners Concord, North Carolina, United States, 28025
    • Durham VA Medical Center Durham, North Carolina, United States, 27705
  • United States, Ohio
    • The Urology Group Cincinnati, Ohio, United States, 45212
    • Kettering Medical 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
    • Northwest Cancer Specialist DBA Compass Oncology Portland, Oregon, United States, 97227
    • Knight Cancer Institute Portland, Oregon, United States, 97239
  • United States, Tennessee
    • Urology Associates Clinical Research Nashville, Tennessee, United States, 37209
  • United States, Texas
    • Urology Clinics of North Texas Dallas, Texas, United States, 75231
    • UT Southwestern Medical Center Dallas, Texas, United States, 75390
    • UT Health Science Center Houston, Texas, United States, 77030
    • Texas Oncology Cancer Center-Round Rock Round Rock, Texas, United States, 78681
  • United States, Virginia
    • Urology of Virginia Virginia Beach, Virginia, United States, 23462
  • United States, Washington
    • MultiCare Regional Cancer Center - Gig Harbor Gig Harbor, Washington, United States, 98335
    • VA Puget Sound HCS Seattle, Washington, United States, 98108
    • University of Washington Fred Hutchinson Cancer Research Center Seattle, Washington, United States, 98109
  • Australia, New South Wales
    • Southside Cancer Care Centre Miranda, New South Wales, Australia, 2228
    • Orange Health Service Orange, New South Wales, Australia, 2800
    • Northern Cancer Insitute, St. Leonards Saint Leonards, New South Wales, Australia, 2065
  • Australia, Western Australia
    • St John of God Hospital, Subiaco Subiaco, Western Australia, Australia, 6008
  • Australia,
    • Peninsula & Southeast Oncology Frankston, , Australia, 3199
    • Barwon Health, University Hospital Geelong Geelong, , Australia, 3220
    • Royal Hobart Hospital Hobart, , Australia, 7000
    • Riverina Cancer Care Centre Wagga Wagga, , Australia, 2650
  • Belgium,
    • ZNA Middelheim Antwerp, , Belgium, 2020
    • AZ Groeninge Kortrijk, , Belgium, 8500
    • CHU Sart-Tilman Liège, , Belgium, 4000
    • Clinique et Maternité Sainte-Elisabeth Namur, , Belgium, 5000
  • Canada, Alberta
    • Tom Baker Cancer Centre Calgary, Alberta, Canada, T2N 4N2
  • Canada, Manitoba
    • Cancer Care Manitoba Winnipeg, Manitoba, Canada, R3E 0V9
  • Canada, New Brunswick
    • Centre Hospitalier Universitaire Dr-Georges-L.-Dumont Moncton, New Brunswick, Canada, E1C 8X3
  • Canada, Ontario
    • London Health Sciences Centre London, Ontario, Canada, N6A 4L6
    • The Ottawa Hospital Ottawa, Ontario, Canada, K1H8L6
    • Princess Margaret Cancer Centre Toronto, Ontario, Canada, M5G 2M9
  • Canada,
    • Lakeridge Health Medical Specialty Medical Oncology Oshawa, , Canada, L1G 2B9
    • Sunnybrook Odette Cancer Centre Toronto, , Canada, M4N3M5
  • Denmark,
    • Copenhagen University Hospital Copenhagen, , Denmark, 2100
    • Herlev Hospital Herlev, , Denmark, 2730
    • Vejle Sygehus Vejle, , Denmark, 7100
  • France,
    • Centre Georges François Leclerc Dijon, , France, 21079
    • Clinique Victor Hugo Centre Jean Bernard Le Mans, , France, 72000
    • Hôpital Privé La Louvière Lille, , France, 59000
    • Centre Léon Bérard Lyon, , France, 69008
    • Polyclinique de Gentilly (Centre D'Oncologie De Gentilly) Nancy, , France, 54000
    • Institut Curie Paris, , France, 75248
    • Centre Armoricain de Radiotherapie, Imagerie medicale et Oncologie, CARIO Plérin, , France, 22190
    • CRLCC Eugene Marquis Rennes, , France, 35042
    • Institut Gustave-Roussy Villejuif, , France, 94805
  • Germany,
    • Gemeinschaftspraxis für Hämatologie&Onkologie Augsburg, , Germany, 86150
    • Charite - Universitaetsmedizin Berlin Berlin, , Germany, 12200
    • Apotheke des Städtischen Klinikums Braunschweig Braunschweig, , Germany, 38102
    • University Hospital Carl Gustav Carus Dresden, , Germany, 01307
    • Universitatsklinikum Dusseldorf Dusseldorf, , Germany, 40225
    • Urologische Gemeinschaftspraxis Emmendingen, , Germany, 79312
    • Universitaetsklinikum Hamburg-Eppendorf (UKE) Hamburg, , Germany, 20246
    • Universitatsklinikum Jena Jena, , Germany, 07747
    • Universitätsklinikum Köln Köln, , Germany, 50937
    • Universitätsklinikum Schleswig-Holstein Lubeck, , Germany, 23538
    • Medizinischen Fakultät Mannheim der Universität Heidelberg Mannheim, , Germany, 68167
    • Studienpraxis Urologie Nurtingen, , Germany, 72622
    • University of Tuebingen Tuebingen, , Germany, 72076
    • Die GesundheitsUnion (DGU) Wuppertal, , Germany, 42103
  • Ireland,
    • Cork University Hospital Cork, , Ireland,
    • Adelaide & Meath Hospital, Incorporating the National Children's Hospital Dublin, , Ireland,
    • Mater Misericordiae University Hospital Dublin, , Ireland,
    • Mater Private Hospital (MPH) Dublin, , Ireland,
    • St James's Hospital Dublin, , Ireland,
    • St. Vincent's University Hospital Dublin, , Ireland,
  • Israel,
    • Rambam Health Care Campus (RHCC), Rambam Medical Center Haifa, , Israel, 3109601
    • Hadassah University Hospital Jerusalem, , Israel, 91120
    • Meir Medical Center Kfar Saba, , Israel, 4428164
    • Rabin Medical Center-Beilinson Campus Petach Tikva, , Israel, 4941492
    • The Tel Aviv Sourasky Medical Center (Ichilov Hospital) Tel Aviv, , Israel, 6423
    • Chaim Sheba Medical Center Tel Hashomer, , Israel, 5262000
  • Italy,
    • Ospedale San Donato, Azienda USLSUDEST Arezzo, , Italy, 52100
    • Ospedale Santa Maria delle Croci Faenza, , Italy, 48018
    • Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica Meldola, , Italy, 47014
    • IEO Instituto Europeo di Oncologia Milano, , Italy, 20141
    • University of Modena and Reggio Emilia Modena, , Italy, 41124
    • Azienda Ospedaliera San Camillo-Forlanini Roma, , Italy, 00152
    • Azienda Opsedaliera S. Maria di Terni Terni, , Italy, 05100
    • Presidio Ospedaliero Santa Chiara di Trento Trento, , Italy, 38122
  • Spain,
    • Hospital Universitari Germans Trias i Pujol Barcelona, , Spain, 08916
    • Hospital Universitario Reina Sofia Córdoba, , Spain, 14004
    • Hospital General Universitario de Guadalajara Guadalajara, , Spain, 19002
    • Hospital Universitario Lucus Augusti. Lugo, , Spain, 27004
    • 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 Clinico Universitario Virgen de la Victoria Málaga, , Spain, 29010
    • Hospital Universitario Central de Asturias Oviedo, , Spain, 33011
    • Corporacio Sanitaria Parc Tauli Sabadell, , Spain, 08208
    • Marques de Valdecilla University Hospital (HUMV) Santander, , Spain, 39008
    • Hospital Universitario Virgen del Rocío Sevilla, , Spain, 41013
    • Instituto Valenciano de Oncología Valencia, , Spain, 46009
  • United Kingdom, England
    • Guy's and St Thomas' NHS Foundation Trust London, England, United Kingdom, SE1 9RT
    • Royal Marsden Hospital London, England, United Kingdom, SM2 5PT
    • Oxford Cancer Centre, Medical Oncology Unit Oxford, England, United Kingdom, OX3 7LE
    • Royal Preston Hospital Preston, England, United Kingdom, PR2 9HT
    • Wexham Park Hospital Slough, England, United Kingdom, SL2 4HL
  • United Kingdom,
    • Velindre Hospital Cardiff, , United Kingdom, CF14 2TL
    • Royal Marsden Hospital London, , United Kingdom, SM2 5PT
    • Musgrove Park Hospital Taunton, , United Kingdom, TA15DA
    • The Clatterbridge Cancer Centre NHS Foundation Trust Wirral, , United Kingdom, CH63 4JY

Sponsors and Collaborators

Clovis Oncology, Inc.

Foundation Medicine

More Information

No publications provided

Responsible Party: Sponsor
ClinicalTrials.gov Identifier: NCT02975934
Other Study ID Numbers:
Study First Received:
Last Updated:
Health Authority:

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:

Prostatic Neoplasms

Docetaxel

Abiraterone Acetate

Rucaparib

Next Steps


If you are interested in this protocol or in other treatment options at Massachusetts General Hospital, please Request a Consultation.







ClinicalTrials.gov processed this data on April 09, 2020