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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.
October 24, 2016
November 2, 2016
November 6, 2017
November 2016
October 2019   (Final data collection date for primary outcome measure)
  • 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) ]
Same as current
Complete list of historical versions of study NCT02952534 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Castration Resistant Prostate Cancer
Drug: Rucaparib
Rucaparib will be administered daily
Other Name: CO-338
Experimental: Rucaparib
Oral rucaparib (monotherapy)
Intervention: Drug: Rucaparib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
April 2020
October 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
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
Australia,   Canada,   Denmark,   France,   Ireland,   Spain,   United Kingdom,   United States
 
 
NCT02952534
CO-338-052
Yes
Not Provided
Not Provided
Clovis Oncology, Inc.
Clovis Oncology, Inc.
Foundation Medicine
Not Provided
Clovis Oncology, Inc.
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP