Clinical Trials /

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

NCT02952534

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.

Related Conditions:
  • Prostate Adenocarcinoma
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
  • 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

Clinical Trial IDs

  • ORG STUDY ID: CO-338-052
  • NCT ID: NCT02952534

Conditions

  • Metastatic Castration Resistant Prostate Cancer

Interventions

DrugSynonymsArms
RucaparibCO-338Rucaparib

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.

Trial Arms

NameTypeDescriptionInterventions
RucaparibExperimentalOral rucaparib (monotherapy)
  • Rucaparib

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

Primary Outcome Measures

Measure:Objective Response Rate (ORR)
Time Frame:From enrollment to primary completion of study (up to approximately 3 years)
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Duration of Response (DOR)
Time Frame:From enrollment to completion of study (up to approximately 3 years and 6 months)
Safety Issue:
Description:
Measure:Radiologic Progression-free Survival (rPFS)
Time Frame:From enrollment to completion of study (up to approximately 3 years and 6 months)
Safety Issue:
Description:
Measure:Overall Survival (OS)
Time Frame:From enrollment to completion of study (up to approximately 3 years and 6 months)
Safety Issue:
Description:
Measure: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)
Safety Issue:
Description:
Measure:Time to PSA Progression
Time Frame:From enrollment to primary completion of study (up to approximately 3 years)
Safety Issue:
Description:
Measure: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 Issue:
Description:
Measure: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)
Safety Issue:
Description: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

Details

Phase:Phase 2
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
  • BARD1
  • BRIP1
  • CDK12
  • CHEK2
  • FANCA
  • NBN
  • PALB2
  • RAD51
  • RAD51B
  • RAD51C
  • RAD51D
  • RAD54L
  • germline
  • somatic
  • mCRPC

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