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

This study is currently recruiting participants.
Verified September 2017 by Clovis Oncology, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02975934
First Posted: November 29, 2016
Last Update Posted: September 14, 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.
November 19, 2016
November 29, 2016
September 14, 2017
January 2017
February 2022   (Final data collection date for primary outcome measure)
Radiographic Progression-free Survival (rPFS) [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
Same as current
Complete list of historical versions of study NCT02975934 on ClinicalTrials.gov Archive Site
  • Objective Response Rate (ORR) [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  • Duration of Response (DOR) [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  • Time to Prostate Specific Antigen (PSA) Progression [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  • PSA Response [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  • Change in Patient-reported Outcome (PRO) [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  • 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) ]
  • Overall Survival [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  • Trough plasma PK (Cmin) of rucaparib based on sparse sampling [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  • 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
  • Objective Response Rate (ORR) [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  • Duration of Response (DOR) [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  • Time to Prostate Specific Antigen (PSA) Progression [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  • PSA Response [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  • Change in Patient-reported Outcome (PRO) [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  • 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) ]
  • Overall Survival [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  • Trough plasma PK (Cmin) of rucaparib based on sparse sampling [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  • Composite assessment of treatment-emergent adverse events (AEs), laboratory abnormalities, vital sign abnormalities, electrocardiogram (ECG) abnormalities, physical examination abnormalities and ECOG abnormalities [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
Not Provided
Not Provided
 
A Study of Rucaparib Verses Physician's Choice of Therapy in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
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
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 verses treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Castration Resistant Prostate Cancer
  • Drug: Rucaparib
    Rucaparib will be administered daily.
    Other Name: CO-338
  • 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)
  • Experimental: Rucaparib
    Oral rucaparib (monotherapy).
    Intervention: Drug: Rucaparib
  • 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).
    Intervention: Drug: Abiraterone acetate or Enzalutamide or Docetaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
April 2022
February 2022   (Final data collection date for primary outcome measure)

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
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
Canada,   United States
 
 
NCT02975934
CO-338-063
Yes
Not Provided
Not Provided
Clovis Oncology, Inc.
Clovis Oncology, Inc.
Foundation Medicine
Not Provided
Clovis Oncology, Inc.
September 2017

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