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

Sponsor
Clovis Oncology, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02975934
Collaborator
Foundation Medicine (Industry)
405
Enrollment
150
Locations
2
Arms
68.6
Anticipated Duration (Months)
2.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
405 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 :
Jun 13, 2017
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Rucaparib

Oral rucaparib (monotherapy).

Drug: Rucaparib
Rucaparib will be administered daily.
Other Names:
  • 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 Names:
  • Zytiga (abiraterone acetate) or Xtandi (enzalutamide) or Taxotere (docetaxel)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Radiographic Progression-free Survival (rPFS) [From enrollment to primary completion of study (up to approximately 5 years)]

    Secondary Outcome Measures

    1. Overall Survival [From enrollment to primary completion of study (up to approximately 5 years)]

    2. Objective Response Rate (ORR) [From enrollment to primary completion of study (up to approximately 5 years)]

    3. Duration of Response (DOR) [From enrollment to primary completion of study (up to approximately 5 years)]

    4. Time to Prostate Specific Antigen (PSA) Progression [From enrollment to primary completion of study (up to approximately 5 years)]

    5. PSA Response [From enrollment to primary completion of study (up to approximately 5 years)]

    6. Change in Patient-reported Outcome (PRO) [From enrollment to primary completion of study (up to approximately 5 years)]

    7. 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 [From enrollment to primary completion of study (up to approximately 5 years)]

    8. Trough plasma PK (Cmin) of rucaparib based on sparse sampling [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy 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

    • 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

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35233
    2 Mayo Clinic - Arizona Phoenix Arizona United States 85054
    3 Arizona Oncology Associates - USOR Tucson Arizona United States 85704
    4 University of Southern California Beverly Hills California United States 90210
    5 Alliance Research Centers Laguna Hills California United States 92653
    6 VA Greater Los Angeles Healthcare System Los Angeles California United States 90073
    7 San Bernardino Urological Associates San Bernardino California United States 92404
    8 Sharp Memorial Hospital San Diego California United States 92123
    9 Pacific Hematology Oncology Associates San Francisco California United States 94115
    10 San Francisco VA Health Care System San Francisco California United States 94121
    11 UCSF Helen Diller Family Comprehensive Cancer Center San Francisco California United States 94158
    12 St. Joseph Heritage Healthcare Santa Rosa California United States 95403
    13 Kaiser Permanente, Northern CA Vallejo California United States 94589
    14 Rocky Mountain Cancer Centers Aurora Colorado United States 80012
    15 Yale University School of Medicine New Haven Connecticut United States 06510
    16 Medical Oncology Hematology Consultants - USOR Newark Delaware United States 19713
    17 Boca Raton Community Hospital, Inc. Boca Raton Florida United States 33486
    18 University of Florida Health Cancer Center Orlando Florida United States 32806
    19 Atlanta Urological Group Atlanta Georgia United States 30312
    20 Kaiser Permanente Medical Group Honolulu Hawaii United States 96819
    21 Ochsner Medical Center New Orleans Louisiana United States 70121
    22 University of Maryland Greenebaum Cancer Center Baltimore Maryland United States 21201
    23 Walter Reed National Military Medical Center Bethesda Maryland United States 20889
    24 Maryland Oncology Hematology P.A. Columbia Maryland United States 21044
    25 Massachusetts General Hospital Boston Massachusetts United States 02114
    26 VA Ann Arbor Healthcare System Ann Arbor Michigan United States 48105
    27 Henry Ford Hospital Detroit Michigan United States 48202
    28 Minnesota Oncology Hematology, P.A. Minneapolis Minnesota United States 55404
    29 Minnesota Veterans Research Institute Minneapolis Minnesota United States 55417
    30 University of Minnesota Minneapolis Minnesota United States 55455
    31 Mayo Clinic - Rochester, MN Rochester Minnesota United States 55902
    32 Alegent Health Bergan Mercy Hospital , GU Research Network Omaha Nebraska United States 68130
    33 Nebraska Cancer Specialists Omaha Nebraska United States 68130
    34 Comprehensive Cancer Centers of Nevada Las Vegas Nevada United States 89169
    35 Premier Urology Associates Lawrenceville New Jersey United States 08648
    36 Roswell Park Buffalo New York United States 14263
    37 NYU Perlmutter Cancer Center New York New York United States 10016
    38 Memorial Sloan Kettering CC New York New York United States 10065
    39 Weill Cornell Medical College New York New York United States 10065
    40 Premier MEdical Group of the Hudson Valley PC Poughkeepsie New York United States 12601
    41 University of Rochester Rochester New York United States 14642
    42 SUNY Upstate Medical University Syracuse New York United States 13210
    43 University of North Carolina Lineberger Cancer Center Chapel Hill North Carolina United States 27599
    44 Carolina Urology Partners Concord North Carolina United States 28025
    45 Durham VA Medical Center Durham North Carolina United States 27705
    46 Oncology Hematology Care Cincinnati Ohio United States 45211
    47 The Urology Group Cincinnati Ohio United States 45212
    48 Kettering Medical Center Kettering Ohio United States 45429
    49 Clinical Research Solutions Middleburg Heights Ohio United States 44130
    50 VA Portland Health Care System Portland Oregon United States 97219
    51 Northwest Cancer Specialist DBA Compass Oncology Portland Oregon United States 97227
    52 Knight Cancer Institute Portland Oregon United States 97239
    53 Urology Associates Clinical Research Nashville Tennessee United States 37209
    54 Urology Clinics of North Texas Dallas Texas United States 75231
    55 UT Southwestern Medical Center Dallas Texas United States 75390
    56 UT Health Science Center Houston Texas United States 77030
    57 Texas Oncology Cancer Center-Round Rock Round Rock Texas United States 78681
    58 Urology of Virginia Virginia Beach Virginia United States 23462
    59 MultiCare Regional Cancer Center - Gig Harbor Gig Harbor Washington United States 98335
    60 VA Puget Sound HCS Seattle Washington United States 98108
    61 University of Washington Fred Hutchinson Cancer Research Center Seattle Washington United States 98109
    62 Southside Cancer Care Centre Miranda New South Wales Australia 2228
    63 Orange Health Service Orange New South Wales Australia 2800
    64 Northern Cancer Insitute, St. Leonards Saint Leonards New South Wales Australia 2065
    65 St John of God Hospital, Subiaco Subiaco Western Australia Australia 6008
    66 Peninsula & Southeast Oncology Frankston Australia 3199
    67 Barwon Health, University Hospital Geelong Geelong Australia 3220
    68 Royal Hobart Hospital Hobart Australia 7000
    69 Riverina Cancer Care Centre Wagga Wagga Australia 2650
    70 ZNA Middelheim Antwerp Belgium 2020
    71 AZ Groeninge Kortrijk Belgium 8500
    72 CHU Sart-Tilman Liège Belgium 4000
    73 Clinique et Maternité Sainte-Elisabeth Namur Belgium 5000
    74 Tom Baker Cancer Centre Calgary Alberta Canada T2N 4N2
    75 Cancer Care Manitoba Winnipeg Manitoba Canada R3E 0V9
    76 Centre Hospitalier Universitaire Dr-Georges-L.-Dumont Moncton New Brunswick Canada E1C 8X3
    77 London Health Sciences Centre London Ontario Canada N6A 4L6
    78 The Ottawa Hospital Ottawa Ontario Canada K1H8L6
    79 Princess Margaret Cancer Centre Toronto Ontario Canada M5G 2M9
    80 Lakeridge Health Medical Specialty Medical Oncology Oshawa Canada L1G 2B9
    81 Sunnybrook Odette Cancer Centre Toronto Canada M4N3M5
    82 Copenhagen University Hospital Copenhagen Denmark 2100
    83 Herlev Hospital Herlev Denmark 2730
    84 Vejle Sygehus Vejle Denmark 7100
    85 Centre Georges François Leclerc Dijon France 21079
    86 Clinique Victor Hugo Centre Jean Bernard Le Mans France 72000
    87 Hôpital Privé La Louvière Lille France 59000
    88 Centre Léon Bérard Lyon France 69008
    89 Polyclinique de Gentilly (Centre D'Oncologie De Gentilly) Nancy France 54000
    90 Institut Curie Paris France 75248
    91 Centre Armoricain de Radiotherapie, Imagerie medicale et Oncologie, CARIO Plérin France 22190
    92 CRLCC Eugene Marquis Rennes France 35042
    93 Institut Gustave-Roussy Villejuif France 94805
    94 Gemeinschaftspraxis für Hämatologie&Onkologie Augsburg Germany 86150
    95 Charite - Universitaetsmedizin Berlin Berlin Germany 12200
    96 Apotheke des Städtischen Klinikums Braunschweig Braunschweig Germany 38102
    97 University Hospital Carl Gustav Carus Dresden Germany 01307
    98 Universitatsklinikum Dusseldorf Dusseldorf Germany 40225
    99 Urologische Gemeinschaftspraxis Emmendingen Germany 79312
    100 Universitaetsklinikum Hamburg-Eppendorf (UKE) Hamburg Germany 20246
    101 Universitatsklinikum Jena Jena Germany 07747
    102 Universitätsklinikum Köln Köln Germany 50937
    103 Universitätsklinikum Schleswig-Holstein Lubeck Germany 23538
    104 Medizinischen Fakultät Mannheim der Universität Heidelberg Mannheim Germany 68167
    105 Studienpraxis Urologie Nurtingen Germany 72622
    106 University of Tuebingen Tuebingen Germany 72076
    107 Die GesundheitsUnion (DGU) Wuppertal Germany 42103
    108 Cork University Hospital Cork Ireland
    109 Adelaide & Meath Hospital, Incorporating the National Children's Hospital Dublin Ireland
    110 Mater Misericordiae University Hospital Dublin Ireland
    111 Mater Private Hospital (MPH) Dublin Ireland
    112 St James's Hospital Dublin Ireland
    113 St. Vincent's University Hospital Dublin Ireland
    114 Rambam Health Care Campus (RHCC), Rambam Medical Center Haifa Israel 3109601
    115 Hadassah University Hospital Jerusalem Israel 91120
    116 Meir Medical Center Kfar Saba Israel 4428164
    117 Rabin Medical Center-Beilinson Campus Petach Tikva Israel 4941492
    118 The Tel Aviv Sourasky Medical Center (Ichilov Hospital) Tel Aviv Israel 6423
    119 Chaim Sheba Medical Center Tel Hashomer Israel 5262000
    120 Ospedale San Donato, Azienda USLSUDEST Arezzo Italy 52100
    121 Ospedale Santa Maria delle Croci Faenza Italy 48018
    122 Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica Meldola Italy 47014
    123 IEO Instituto Europeo di Oncologia Milano Italy 20141
    124 University of Modena and Reggio Emilia Modena Italy 41124
    125 Azienda Ospedaliera San Camillo-Forlanini Roma Italy 00152
    126 Azienda Opsedaliera S. Maria di Terni Terni Italy 05100
    127 Presidio Ospedaliero Santa Chiara di Trento Trento Italy 38122
    128 Hospital Universitari Germans Trias i Pujol Barcelona Spain 08916
    129 Hospital Universitario Reina Sofia Córdoba Spain 14004
    130 Hospital General Universitario de Guadalajara Guadalajara Spain 19002
    131 Hospital Universitario Lucus Augusti. Lugo Spain 27004
    132 MD Anderson Cancer Center - Madrid Madrid Spain 28033
    133 Hospital Universitario Ramón y Cajal Madrid Spain 28034
    134 Hospital 12 de Octubre Madrid Spain 28041
    135 Hospital Universitario La Paz Madrid Spain 28046
    136 Hospital Clinico Universitario Virgen de la Victoria Málaga Spain 29010
    137 Hospital Universitario Central de Asturias Oviedo Spain 33011
    138 Corporacio Sanitaria Parc Tauli Sabadell Spain 08208
    139 Marques de Valdecilla University Hospital (HUMV) Santander Spain 39008
    140 Hospital Universitario Virgen del Rocío Sevilla Spain 41013
    141 Instituto Valenciano de Oncología Valencia Spain 46009
    142 Guy's and St Thomas' NHS Foundation Trust London England United Kingdom SE1 9RT
    143 Royal Marsden Hospital London England United Kingdom SM2 5PT
    144 Oxford Cancer Centre, Medical Oncology Unit Oxford England United Kingdom OX3 7LE
    145 Royal Preston Hospital Preston England United Kingdom PR2 9HT
    146 Wexham Park Hospital Slough England United Kingdom SL2 4HL
    147 Velindre Hospital Cardiff United Kingdom CF14 2TL
    148 Royal Marsden Hospital London United Kingdom SM2 5PT
    149 Musgrove Park Hospital Taunton United Kingdom TA15DA
    150 The Clatterbridge Cancer Centre NHS Foundation Trust Wirral United Kingdom CH63 4JY

    Sponsors and Collaborators

    • Clovis Oncology, Inc.
    • Foundation Medicine

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Clovis Oncology, Inc.
    ClinicalTrials.gov Identifier:
    NCT02975934
    Other Study ID Numbers:
    • CO-338-063
    First Posted:
    Nov 29, 2016
    Last Update Posted:
    Mar 24, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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:
    Prostatic Neoplasms
    Docetaxel
    Abiraterone Acetate
    Rucaparib

    Study Results

    No Results Posted as of Mar 24, 2022