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Trial record 1 of 1 for:    triton3
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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 December 2017 by Clovis Oncology, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02975934
First Posted: November 29, 2016
Last Update Posted: December 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 verses treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

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

Secondary Outcome Measures:
  • 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


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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 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
  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): 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

  Show 42 Study Locations
Sponsors and Collaborators
Clovis Oncology, Inc.
Foundation Medicine
  More Information

Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT02975934     History of Changes
Other Study ID Numbers: CO-338-063
First Submitted: November 19, 2016
First Posted: November 29, 2016
Last Update Posted: December 6, 2017
Last Verified: December 2017

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