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A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON2)

This study is currently recruiting participants.
Verified November 2017 by Clovis Oncology, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02952534
First Posted: November 2, 2016
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Foundation Medicine
Information provided by (Responsible Party):
Clovis Oncology, Inc.
  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 Intervention Phase
Metastatic Castration Resistant Prostate Cancer Drug: Rucaparib Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Clovis Oncology, Inc.:

Primary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: From enrollment to primary completion of study (up to approximately 3 years) ]
  • Prostate Specific Antigen (PSA) Response [ Time Frame: From enrollment to primary completion of study (up to approximately 3 years) ]

Secondary Outcome Measures:
  • Duration of Response (DOR) [ Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months) ]
  • Radiologic Progression-free Survival (rPFS) [ Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months) ]
  • Overall Survival (OS) [ Time Frame: From enrollment to completion of study (up to approximately 3 years and 6 months) ]
  • 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) ]
  • Time to PSA Progression [ Time Frame: From enrollment to primary completion of study (up to approximately 3 years) ]
  • 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 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) ]
    This is a composite outcome. It will be assessed by incidence, type, seriousness, and severity of AEs reported; clinical laboratory investigations (hematology, serum chemistry and urinalysis); Vital signs (blood pressure, heart rate, and body temperature); 12 lead ECGs; Physical examinations; and ECOG performance status


Estimated Enrollment: 160
Study Start Date: November 2016
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rucaparib
Oral rucaparib (monotherapy)
Drug: Rucaparib
Rucaparib will be administered daily
Other Name: CO-338

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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): NCT02952534


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
Laguna Hills, California, United States
Recruiting
Los Angeles, 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, District of Columbia
Recruiting
Washington, District of Columbia, United States
United States, Florida
Recruiting
Boca Raton, Florida, United States
Recruiting
Fort Myers, Florida, United States
Recruiting
Orlando, Florida, United States
Recruiting
Tampa, Florida, United States
United States, Georgia
Recruiting
Atlanta, Georgia, United States
United States, Illinois
Recruiting
Chicago, Illinois, United States
United States, Maryland
Recruiting
Baltimore, Maryland, United States
United States, Michigan
Recruiting
Detroit, Michigan, United States
United States, Minnesota
Recruiting
Minneapolis, Minnesota, United States
United States, Missouri
Recruiting
Kansas City, Missouri, United States
United States, Nebraska
Recruiting
Omaha, Nebraska, United States
United States, Nevada
Recruiting
Las Vegas, Nevada, United States
United States, New Jersey
Recruiting
New Brunswick, New Jersey, United States
Recruiting
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
United States, North Carolina
Recruiting
Concord, North Carolina, United States
United States, Ohio
Recruiting
Cincinnati, Ohio, United States
Recruiting
Middleburg Heights, Ohio, United States
United States, Oregon
Recruiting
Portland, Oregon, 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
Norfolk, Virginia, United States
United States, Washington
Recruiting
Seattle, Washington, United States
Australia, New South Wales
Recruiting
Saint Leonards, New South Wales, Australia
Australia, Tasmania
Recruiting
Hobart, Tasmania, Australia
Australia, Victoria
Recruiting
Frankston, Victoria, Australia
Recruiting
Geelong, Victoria, Australia
Recruiting
Malvern, Victoria, Australia
Australia
Recruiting
Subiaco, Australia
Canada, Ontario
Recruiting
Hamilton, Ontario, Canada
Recruiting
London, Ontario, Canada
Recruiting
Ottawa, Ontario, Canada
Canada
Recruiting
Toronto, Canada
Denmark
Recruiting
Copenhagen, Denmark
Recruiting
Vejle, Denmark
France
Recruiting
Caen, France
Recruiting
Dijon, France
Recruiting
Nancy, France
Ireland
Recruiting
Dublin, Ireland
Spain
Recruiting
Badalona, Spain
Recruiting
Barcelona, Spain
Recruiting
Madrid, Spain
United Kingdom
Recruiting
Slough, Berkshire, United Kingdom
Recruiting
Northwood, MIddlesex, United Kingdom
Recruiting
Sutton, Surrey, United Kingdom
Recruiting
Headington, United Kingdom
Recruiting
Liverpool, United Kingdom
Recruiting
London, United Kingdom
Sponsors and Collaborators
Clovis Oncology, Inc.
Foundation Medicine
  More Information

Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02952534     History of Changes
Other Study ID Numbers: CO-338-052
First Submitted: October 24, 2016
First Posted: November 2, 2016
Last Update Posted: November 6, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Rucaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents