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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/show/NCT02975934
Registration number
NCT02975934
Ethics application status
Date submitted
19/11/2016
Date registered
29/11/2016
Date last updated
24/12/2020
Titles & IDs
Public title
A Study of Rucaparib Versus Physician's Choice of Therapy in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
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Scientific 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
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Secondary ID [1]
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CO-338-063
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Universal Trial Number (UTN)
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Trial acronym
TRITON3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration Resistant Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rucaparib
Treatment: Drugs - Abiraterone acetate or Enzalutamide or Docetaxel
Experimental: Rucaparib - Oral rucaparib (monotherapy).
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).
Treatment: Drugs: Rucaparib
Rucaparib will be administered daily.
Treatment: Drugs: Abiraterone acetate or Enzalutamide or Docetaxel
Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Radiographic Progression-free Survival (rPFS)
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Timepoint [1]
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From enrollment to primary completion of study (up to approximately 5 years)
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Secondary outcome [1]
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Objective Response Rate (ORR)
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Timepoint [1]
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From enrollment to primary completion of study (up to approximately 5 years)
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Secondary outcome [2]
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Duration of Response (DOR)
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Timepoint [2]
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From enrollment to primary completion of study (up to approximately 5 years)
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Secondary outcome [3]
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Time to Prostate Specific Antigen (PSA) Progression
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Timepoint [3]
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From enrollment to primary completion of study (up to approximately 5 years)
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Secondary outcome [4]
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PSA Response
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Timepoint [4]
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From enrollment to primary completion of study (up to approximately 5 years)
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Secondary outcome [5]
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Change in Patient-reported Outcome (PRO)
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Timepoint [5]
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From enrollment to primary completion of study (up to approximately 5 years)
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Secondary outcome [6]
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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
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Timepoint [6]
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Secondary outcome [7]
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Overall Survival
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Timepoint [7]
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Secondary outcome [8]
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Trough plasma PK (Cmin) of rucaparib based on sparse sampling
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Timepoint [8]
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From enrollment to primary completion of study (up to approximately 5 years)
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Secondary outcome [9]
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Number of participants with Adverse Events (AEs) as a measure of safety and tolerability - Composite assessment of treatment-emergent AEs, including laboratory abnormalities, vital sign abnormalities, electrocardiogram (ECG) abnormalities, physical examination abnormalities and ECOG abnormalities
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Timepoint [9]
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From enrollment to primary completion of study (up to approximately 5 years)
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Eligibility
Key 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
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Minimum age
18
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Maximum age
No limit
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Gender
Males
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/06/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2022
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Actual
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Sample size
Target
400
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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Southside Cancer Care Centre - Miranda
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Orange Health Service - Orange
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Northern Cancer Insitute, St. Leonards - Saint Leonards
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St John of God Hospital, Subiaco - Subiaco
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Peninsula & Southeast Oncology - Frankston
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Barwon Health, University Hospital Geelong - Geelong
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Royal Hobart Hospital - Hobart
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Riverina Cancer Care Centre - Wagga Wagga
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2228 - Miranda
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2800 - Orange
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2065 - Saint Leonards
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6008 - Subiaco
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3199 - Frankston
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3220 - Geelong
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7000 - Hobart
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2650 - Wagga Wagga
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Clovis Oncology, Inc.
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Foundation Medicine
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Ethics approval
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/show/NCT02975934
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Contacts
Principal investigator
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Clovis Oncology For North America, Latin America and Asia Pacific inquires:
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1-415-409-7220; 1-844-258-7662
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medinfo@clovisoncology.com
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Contact person for scientific queries
Summary results
For IPD and results data, please see
https://clinicaltrials.gov/show/NCT02975934
Download to PDF