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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

NCT02975934

Description:

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.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study of Rucaparib Versus Physician's Choice of Therapy in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CO-338-063
  • NCT ID: NCT02975934

Conditions

  • Metastatic Castration Resistant Prostate Cancer

Interventions

DrugSynonymsArms
RucaparibCO-338Rucaparib
Abiraterone acetate or Enzalutamide or DocetaxelZytiga (abiraterone acetate) or Xtandi (enzalutamide) or Taxotere (docetaxel)Abiraterone acetate or Enzalutamide or Docetaxel

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 versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.

Trial Arms

NameTypeDescriptionInterventions
RucaparibExperimentalOral rucaparib (monotherapy).
  • Rucaparib
Abiraterone acetate or Enzalutamide or DocetaxelActive ComparatorOral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
  • Abiraterone acetate or Enzalutamide or Docetaxel

Eligibility 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 that is metastatic

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Radiographic Progression-free Survival (rPFS)
Time Frame:From enrollment to primary completion of study (up to approximately 5 years)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:From enrollment to primary completion of study (up to approximately 5 years)
Safety Issue:
Description:
Measure:Duration of Response (DOR)
Time Frame:From enrollment to primary completion of study (up to approximately 5 years)
Safety Issue:
Description:
Measure:Time to Prostate Specific Antigen (PSA) Progression
Time Frame:From enrollment to primary completion of study (up to approximately 5 years)
Safety Issue:
Description:
Measure:PSA Response
Time Frame:From enrollment to primary completion of study (up to approximately 5 years)
Safety Issue:
Description:
Measure:Change in Patient-reported Outcome (PRO)
Time Frame:From enrollment to primary completion of study (up to approximately 5 years)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure:Overall Survival
Time Frame:From enrollment to primary completion of study (up to approximately 5 years)
Safety Issue:
Description:
Measure:Trough plasma PK (Cmin) of rucaparib based on sparse sampling
Time Frame:From enrollment to primary completion of study (up to approximately 5 years)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:Composite assessment of treatment-emergent AEs, including laboratory abnormalities, vital sign abnormalities, electrocardiogram (ECG) abnormalities, physical examination abnormalities and ECOG abnormalities

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Clovis Oncology, Inc.

Trial Keywords

  • CRPC
  • PARP inhibitor
  • PARPi
  • BRCA
  • ATM
  • HRD
  • TRITON
  • homologous recombination
  • DNA repair
  • DNA defect
  • DNA anomaly
  • germline
  • somatic
  • mCRPC

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