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

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ClinicalTrials.gov Identifier: NCT02975934
Recruitment Status : Recruiting
First Posted : November 29, 2016
Last Update Posted : June 12, 2018
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 versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.

Condition or disease Intervention/treatment Phase
Metastatic Castration Resistant Prostate Cancer Drug: Rucaparib Drug: Abiraterone acetate or Enzalutamide or Docetaxel Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 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
Study Start Date : January 2017
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : April 2022


Arm Intervention/treatment
Experimental: Rucaparib
Oral rucaparib (monotherapy).
Drug: Rucaparib
Rucaparib will be administered daily.
Other Name: 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 Name: Zytiga (abiraterone acetate) or Xtandi (enzalutamide) or Taxotere (docetaxel)




Primary Outcome Measures :
  1. Radiographic Progression-free Survival (rPFS) [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]

Secondary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  2. Duration of Response (DOR) [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  3. Time to Prostate Specific Antigen (PSA) Progression [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  4. PSA Response [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  5. Change in Patient-reported Outcome (PRO) [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  6. 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) ]
  7. Overall Survival [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  8. Trough plasma PK (Cmin) of rucaparib based on sparse sampling [ Time Frame: 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 [ Time Frame: 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



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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 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)
  • 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

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): NCT02975934


Contacts
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

  Hide Study Locations
Locations
United States, Alabama
Recruiting
Birmingham, Alabama, United States
United States, Arizona
Recruiting
Phoenix, Arizona, United States
United States, California
Recruiting
Beverly Hills, California, United States
Recruiting
Laguna Hills, California, United States
Recruiting
San Bernardino, California, United States
Recruiting
San Diego, California, United States
Recruiting
San Francisco, California, United States
Recruiting
Santa Rosa, California, United States
United States, Colorado
Recruiting
Aurora, Colorado, United States
United States, Connecticut
Recruiting
New Haven, Connecticut, United States
United States, Florida
Recruiting
Boca Raton, Florida, United States
Recruiting
Orlando, Florida, United States
United States, Georgia
Completed
Atlanta, Georgia, United States
United States, Hawaii
Recruiting
Honolulu, Hawaii, United States
United States, Louisiana
Recruiting
New Orleans, Louisiana, United States
United States, Maryland
Recruiting
Baltimore, Maryland, United States
Recruiting
Bethesda, Maryland, United States
United States, Michigan
Recruiting
Detroit, Michigan, United States
United States, Minnesota
Recruiting
Minneapolis, Minnesota, United States
United States, Nebraska
Recruiting
Omaha, Nebraska, United States
United States, Nevada
Recruiting
Las Vegas, Nevada, United States
United States, New Jersey
Completed
Township, New Jersey, United States
United States, New York
Recruiting
Buffalo, New York, United States
Recruiting
New York, New York, United States
Recruiting
Poughkeepsie, New York, United States
Recruiting
Rochester, New York, United States
Recruiting
Syracuse, New York, United States
United States, North Carolina
Completed
Concord, North Carolina, United States
United States, Ohio
Recruiting
Cincinnati, Ohio, United States
Recruiting
Middleburg Heights, Ohio, United States
United States, Tennessee
Recruiting
Nashville, Tennessee, United States
United States, Texas
Recruiting
Dallas, Texas, United States
Recruiting
Houston, Texas, United States
United States, Virginia
Recruiting
Virginia Beach, Virginia, United States
United States, Washington
Recruiting
Tacoma, Washington, United States
Australia, New South Wales
Recruiting
Saint Leonards, New South Wales, Australia
Australia
Recruiting
Frankston, Australia
Recruiting
Geelong, Australia
Recruiting
Hobart, Australia
Recruiting
Subiaco, Australia
Belgium
Recruiting
Antwerp, Belgium
Recruiting
Kortrijk, Belgium
Recruiting
Liège, Belgium
Recruiting
Namur, Belgium
Canada, Manitoba
Recruiting
Winnipeg, Manitoba, Canada
Canada, New Brunswick
Recruiting
Moncton, New Brunswick, Canada
Canada, Ontario
Recruiting
London, Ontario, Canada
Recruiting
Ottawa, Ontario, Canada
Recruiting
Toronto, Ontario, Canada
Denmark
Recruiting
Copenhagen, Denmark
Recruiting
Herlev, Denmark
Recruiting
Vejle, Denmark
France
Recruiting
Dijon, France
Recruiting
Le Mans, France
Recruiting
Lille, France
Recruiting
Nancy, France
Recruiting
Paris, France
Recruiting
Rennes, France
Recruiting
Villejuif, France
Germany
Recruiting
Tuebingen, Germany
Ireland
Recruiting
Cork, Ireland
Recruiting
Dublin, Ireland
Italy
Recruiting
Roma, Italy
Spain
Recruiting
Barcelona, Spain
Recruiting
Madrid, Spain
Recruiting
Málaga, Spain
Recruiting
Oviedo, Spain
Recruiting
Sabadell, Spain
Recruiting
Valencia, Spain
United Kingdom
Recruiting
London, England, United Kingdom
Recruiting
Oxford, England, United Kingdom
Recruiting
Preston, England, United Kingdom
Recruiting
Slough, England, United Kingdom
Recruiting
Cardiff, United Kingdom
Recruiting
Taunton, United Kingdom
Recruiting
Wirral, United Kingdom
Sponsors and Collaborators
Clovis Oncology, Inc.
Foundation Medicine

Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02975934     History of Changes
Other Study ID Numbers: CO-338-063
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

Keywords provided by Clovis Oncology, Inc.:
CRPC
PARP inhibitor
PARPi
BRCA
ATM
HRD
TRITON
homologous recombination
DNA repair
DNA defect
DNA anomaly
germline
somatic

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Rucaparib
Abiraterone Acetate
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 Enzyme Inhibitors
Poly(ADP-ribose) Polymerase Inhibitors