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.
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
Drug | Synonyms | Arms |
---|
Rucaparib | CO-338 | Rucaparib |
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
Name | Type | Description | Interventions |
---|
Rucaparib | Experimental | Oral rucaparib (monotherapy) | |
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: | Active, not 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
Last Updated
November 27, 2020