Clinical Trial - NCT02952534

A Study of Rucaparib 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: NCT02952534

Protocol Info

Short Description: Rucaparib In Castration-Resistant Prostate Cancer
Long Description: TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in 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.
Condition Title Intervention Phase
Metastatic Castration Resistant Prostate Cancer Rucaparib Phase 2
Study Type Interventional
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

Primary Outcome Measures

Objective Response Rate (ORR) [Time Frame: From enrollment to primary completion of study (up to approximately 3 years)] [Designated as safety issue: ]

Prostate Specific Antigen (PSA) Response [Time Frame: From enrollment to primary completion of study (up to approximately 3 years)] [Designated as safety issue: ]


Secondary Outcome Measures

Duration of Response (DOR) [Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months)] [Designated as safety issue: ]

Radiologic Progression-free Survival (rPFS) [Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months)] [Designated as safety issue: ]

Overall Survival (OS) [Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months)] [Designated as safety issue: ]

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)] [Designated as safety issue: ]

Time to PSA Progression [Time Frame: From enrollment to primary completion of study (up to approximately 3 years)] [Designated as safety issue: ]

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)] [Designated as safety issue: ]

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)] [Designated as safety issue: ]

Estimated Enrollment: 360
Study Start Date: February 2017
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: October 2019
Arms Assigned Interventions

Experimental:Rucaparib

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

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT02952534

Locations

  • United States, Alabama
    • University of Alabama at Birmingham Birmingham, Alabama, United States, 35294
  • United States, Arizona
    • Mayo Clinc Phoenix, Arizona, United States, 85259
  • United States, California
    • Alliance Research Centers Laguna Hills, California, United States, 92653
    • VA Greater Los Angeles Healthcare System Los Angeles, California, United States, 90073
    • University of Southern California Los Angeles, California, United States, 90211
    • Stanford University Palo Alto, California, United States, 94305
    • 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, 94143
    • UCSF Helen Diller Family Comprehensive Cancer Center San Francisco, California, United States, 94158
    • Redwood Regional Medical Group Santa Rosa, California, United States, 95406
    • Kaiser Permanente Medical Center (Vallejo) Vallejo, California, United States, 94589
  • United States, Colorado
    • Rocky Mountain Cancer Centers Aurora, Colorado, United States, 80012
  • United States, Connecticut
    • Yale School of Medicine New Haven, Connecticut, United States, 06510
  • United States, Delaware
    • 4701 Ogletown Stanton Rd. Newark, Delaware, United States, 19713
  • United States, District of Columbia
    • Georgetown University Medical Center Washington, District of Columbia, United States, 20007
  • United States, Florida
    • Boca Raton Community Hospital, Inc. Boca Raton, Florida, United States, 33486
    • Florida Cancer Specialists Fort Myers, Florida, United States, 33980
    • University of Florida Health Cancer Center Orlando, Florida, United States, 32806
    • Moffitt Cancer Center Tampa, Florida, United States, 33612
  • United States, Georgia
    • Atlanta Urological Group Atlanta, Georgia, United States, 30312
  • United States, Illinois
    • University of Chicago Comprehensive Cancer Center Chicago, Illinois, United States, 60637
  • 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
    • Henry Ford Hospital Bethesda, Maryland, United States, 48202
  • 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
    • Fairview Hospital Edina, Minnesota, United States, 55435
    • Minnesota Oncology Hematology, P.A. Minneapolis, Minnesota, United States, 55404
    • Minnesota Veterans Research Institute Minneapolis, Minnesota, United States, 55417
  • United States, Missouri
    • HCA Midwest Division - Kansas City Kansas City, Missouri, United States, 64132
  • United States, Nebraska
    • Alegent Health Bergan Mercy Hospital , GU Research Network Omaha, Nebraska, United States, 68130
  • United States, Nevada
    • Comprehensive Cancer Centers of Nevada Las Vegas, Nevada, United States, 89119
  • United States, New Jersey
    • Premier Urology Associates dba/AdvanceMed Research Lawrenceville, New Jersey, United States, 08648
    • Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey, United States, 08901
  • 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
    • Premier Medical Group of the Hudson Valley PC Poughkeepsie, New York, United States, 12301
    • University of Rochester Rochester, New York, United States, 14642
    • SUNY Upstate Medical University Syracuse, New York, United States, 13210
  • United States, North Carolina
    • Carolina Urology Partners Concord, North Carolina, United States, 28025
  • United States, Ohio
    • The Urology Group Cincinnati, Ohio, United States, 45212
    • Clinical Research Solutions Middleburg Heights, Ohio, United States, 44130
  • United States, Oregon
    • VA Portland Health Care System Portland, Oregon, United States, 97219
  • United States, Tennessee
    • SCRI - Tennessee Oncology Nashville, Tennessee, United States, 37203
  • United States, Texas
    • UT Southwestern Medical Center Dallas, Texas, United States, 75390
    • UT Health Science Center Houston, Texas, United States, 77030
    • Texas Oncology - Tyler Tyler, Texas, United States, 75702
  • United States, Virginia
    • Virginia Oncology Associates Norfolk, Virginia, United States, 23502
  • United States, Washington
    • VA Puget Sound Seattle, Washington, United States, 98108
  • Australia, New South Wales
    • Northern Cancer Insitute, St. Leonards Saint Leonards, New South Wales, Australia, 2065
  • Australia, Tasmania
    • Royal Hobart Hospital Hobart, Tasmania, Australia, 7000
  • Australia, Victoria
    • Peninsula & Southeast Oncology Frankston, Victoria, Australia, 3199
    • Barwon Health, University Hospital Geelong Geelong, Victoria, Australia, 3220
    • Cabrini Hospital Malvern, Victoria, Australia, 3144
  • Australia,
    • Southside Cancer Care Centre Miranda, , Australia, 2228
    • Orange Health Services Orange, , Australia, 2800
    • St John of God Hospital, Subiaco Subiaco, , Australia, 6008
    • Riverina Cancer Care Centre Wagga Wagga, , Australia, 2650
  • Belgium,
    • ZNA Middelheim Antwerp, , Belgium, 2020
    • Universitair Ziekenhuis Gent Gent, , Belgium, B-9000
    • AZ Groeninge Kortrijk, , Belgium, 8500
    • CHU Sart-Tilman Liège, , Belgium, 4000
    • Equipe de Recherche Clinique, Département d'Oncologie/Hématologie Liège, , Belgium, 4000
    • AZ DELTA Roeselare, , Belgium, B-8800
  • Canada, Ontario
    • Juravinski Cancer Centre Hamilton Health Services Hamilton, Ontario, Canada, L8V5C2
    • London Health Science Center - Victoria Hospital London, Ontario, Canada, N6A 4L6
    • The Ottawa Hospital Ottawa, Ontario, Canada, K1H8L6
  • Canada,
    • Princess Margaret Hospital Toronto, , Canada, M5G 2M9
  • Denmark,
    • Copenhagen University Hospital Copenhagen, , Denmark, 2100
    • Herlev Hospital Herlev, , Denmark, 2730
    • Vejle Sygehus Vejle, , Denmark, 7100
  • France,
    • Centre François Baclesse Caen, , France, 14000
    • Centre Georges François Leclerc Dijon, , France, 21079
    • Clinique Victor Hugo Centre Jean Bernard Le Mans, , France, 72000
    • Hôpital Privé La Louvière Lille, , France, 59800
    • Polyclinique de Gentilly (Centre D'Oncologie De Gentilly) Nancy, , France, 54100
    • Institut Curie Paris, , France, 75248
    • Hôpital Privé des Côtes d'Armor Plérin, , France, 22190
    • CRLCC Eugene Marquis Rennes, , France, 35042
  • Germany,
    • Gemeinschaftspraxis fur Hamatologie & Onkologie Augsburg, , Germany, 86150
    • Charite Universitatsmedizin Berlin Berlin, , Germany, 12200
    • Universitatsklinikum Carl Gustav Carus Dresden, , Germany, 01307
    • Urologische Gemeinschaftspraxis Emmendingen, , Germany, 79312
    • Universitaetsklinikum Hamburg-Eppendorf (UKE) Hamburg, , Germany, 20246
    • Universitaetsklinikum Heidelberg Heidelberg, , Germany, 69120
    • Universitatsklinikum Jena Jena, , Germany, 07747
    • Universitätsklinik Köln Köln, , Germany, 50937
    • Universitätsklinikum Schleswig-Holstein Lübeck, , Germany, 23538
    • Medizinischen Fakultät Mannheim der Universität Heidelberg Mannheim, , Germany, 68167
    • Studienpraxis Urologie Nürtingen, , Germany, 72622
    • University of Tuebingen Tuebingen, , Germany, 72076
    • Die Gesundhehitsunion DGU Wuppertal, , Germany, 42103
  • Ireland,
    • Cork University Hospital Cork, , Ireland, T12 DFK4
    • St. Vincent's University Hospital Dublin, , Ireland, D04T6F4
    • St James's Hospital Dublin, , Ireland, D08 NHY1
    • Adelaide & Meath Hospital, Incorporating the National Children's Hospital Dublin, , Ireland, Dublin 24
    • Mater Misericordiae University Hospital Dublin, , Ireland, Dublin 7
  • Israel,
    • Rambam Health Care Campus (RHCC), Rambam Medical Center Haifa, , Israel, 3109601
    • Hadassah University Hospital Jerusalem, , Israel, 71120
    • Meir Medical Center Kfar Saba, , Israel, 4428164
    • Rabin Medical Center-Beilinson Campus Petach Tikva, , Israel, 4941492
    • Chaim Sheba Medical Center Ramat Gan, , Israel, 52621
    • The Tel Aviv Sourasky Medical Center (Ichilov Hospital) Tel Aviv, , Israel, 64231
  • Italy,
    • Ospedale San Donato, Azienda USLSUDEST Arezzo, , Italy, 52100
    • Ospedale Santa Maria delle Croci Faenza, , Italy, 48018
    • IRCCS Istituto Nazionale dei Tumori (INT) Milano, , Italy, 20133
    • IEO Instituto Europeo di Oncologia Milano, , Italy, 20141
    • University of Modena and Reggio Emilia Medical Oncology Modena, , Italy, 41124
    • Azienda Ospedaliera San Camillo-Forlanini Rome, , Italy, 00152
    • Azienda Opsedaliera S. Maria di Terni Terni, , Italy, 05100
    • Santa Chiara Hospital, Dept Medical Oncology Trento, , Italy, 38122
  • Spain,
    • Hospital Universitari Germans Trias i Pujol Badalona, , Spain, 08916
    • Hospital del Mar, Servicio de Oncología Barcelona, , Spain, 08003
    • Hospital Clínic i Provincial de Barcelona-Oncology Barcelona, , Spain, 08036
    • Instituto Catalan de Oncologia Barcelona, , Spain, 08908
    • Hospital Universitari Germans Trias i Pujol Barcelona, , Spain, 08916
    • Hospital Universitario Lucus Augusti. Lugo, , Spain, 27003
    • 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 Puerta de Hierro-Majadahonda Madrid, , Spain, 28222
    • Hospital Universitario Central de Asturias Oviedo, , Spain, 33011
    • Corporacio Sanitaria Parc Tauli Sabadell, , Spain, 8208
    • Marques de Valdecilla University Hospital (HUMV) Santander, , Spain, 39008
    • Hospital Universitario Virgen del Rocío Sevilla, , Spain, 41013
    • Instituto Valenciano de Oncologia IVO Valencia, , Spain, 46009
  • United Kingdom, Berkshire
    • Wexham Park Hospital Slough, Berkshire, United Kingdom, SL2 4HL
  • United Kingdom, England
    • Mount Vernon Cancer Centre Northwood, England, United Kingdom, HA6 2RN
  • United Kingdom, Surrey
    • Royal Marsden Hospital Sutton, Surrey, United Kingdom, SM2 5PT
  • United Kingdom,
    • Oxford University Hospitals Headington, , United Kingdom, OC3 7LJ
    • Royal Liverpool Hospital Liverpool, , United Kingdom, L7 8XP
    • London Health Science Center - Victoria Hospital London, , United Kingdom, N6A 4L6
    • Guy's Hospital London, , United Kingdom, SE1 9RT
    • Sarah Cannon Research Institutute - UK London, , United Kingdom, W1G 6AD
    • Southampton General Hospital Southampton, , United Kingdom, SO16 6YD
    • Musgrove Park Hospital Taunton, , United Kingdom, TA1 5DA
    • 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: NCT02952534
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

BARD1

BRIP1

CDK12

CHEK2

FANCA

NBN

PALB2

RAD51

RAD51B

RAD51C

RAD51D

RAD54L

germline

somatic

mCRPC

Additional relevant MeSH terms:

Prostatic Neoplasms

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 May 30, 2019