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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02952534
Registration number
NCT02952534
Ethics application status
Date submitted
24/10/2016
Date registered
2/11/2016
Date last updated
9/06/2023
Titles & IDs
Public title
A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
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Scientific title
TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency
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Secondary ID [1]
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2016-003162-13
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Secondary ID [2]
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CO-338-052
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Universal Trial Number (UTN)
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Trial acronym
TRITON2
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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
Experimental: Rucaparib - Oral rucaparib (monotherapy)
Treatment: Drugs: Rucaparib
Rucaparib will be administered daily
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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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Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Central Independent Radiology Review (IRR)
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Assessment method [1]
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The primary efficacy endpoint is confirmed radiographic ORR by central IRR. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by mRECIST (modified Response Evaluation Criteria in Solid Tumors) v1.1/PCWG3 (Prostate Cancer Working Group 3) criteria. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation in the absence of confirmed progression in bone. CR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
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Timepoint [1]
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Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
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Secondary outcome [1]
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Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Investigator (INV)
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Assessment method [1]
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A supportive efficacy endpoint is confirmed radiographic ORR by INV. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by mRECIST (modified Response Evaluation Criteria in Solid Tumors) v1.1/PCWG3 (Prostate Cancer Working Group 3) criteria. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation in the absence of confirmed progression in bone. CR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
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Timepoint [1]
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Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
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Secondary outcome [2]
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Duration of Response (DOR) by Gene in Patients With Confirmed Response Per Central Independent Radiology Review (IRR)
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Assessment method [2]
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A secondary efficacy endpoint is DOR by central IRR. The DOR is defined as the time from the date that a confirmed response per modified RECIST Version 1.1/PCWG3 is first reported to the time that progressive disease (PD) is first documented. Progressive disease is defined using RECIST v1.1, as at least a 20% increase in the sum of the diameters of target lesions, or an unequivocal increase in non-target lesions, or the appearance of new lesions. PCWG3 criteria is used to document evidence of disease progression in bone lesions.
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Timepoint [2]
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Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
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Secondary outcome [3]
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Duration of Response (DOR) by Gene in Patients With Confirmed Response Per Investigator
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Assessment method [3]
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A secondary efficacy endpoint is DOR as assessed by the investigator. The DOR is defined as the time from the date that a confirmed response per modified RECIST Version 1.1/PCWG3 is first reported to the time that progressive disease (PD) is first documented. Progressive disease is defined using RECIST v1.1, as at least a 20% increase in the sum of the diameters of target lesions, or an unequivocal increase in non-target lesions, or the appearance of new lesions. PCWG3 criteria is used to document evidence of disease progression in bone lesions.
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Timepoint [3]
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Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
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Secondary outcome [4]
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Confirmed PSA Response (= 50% Decrease) by Gene as Assessed by Local Laboratory
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Assessment method [4]
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A secondary endpoint is confirmed PSA (prostate-specific antigen) response (= 50% reduction) as assessed by local laboratory. Confirmed PSA response is analyzed for all patients who had PSA value at baseline and is defined as the percentage of patients having 2 consecutive PSA values (at least 3 weeks apart) that are at least 50% lower than baseline and that occur prior to PSA progression. PSA progression is defined as a = 25% increase and absolute increase of = 2 ng/mL above the nadir in PSA.
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Timepoint [4]
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PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.
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Secondary outcome [5]
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Confirmed PSA Response (= 90% Decrease) by Gene as Assessed by Local Laboratory
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Assessment method [5]
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A secondary endpoint is confirmed PSA (prostate-specific antigen) response (= 90% reduction) as assessed by local laboratory. Confirmed PSA response is analyzed for all patients who had PSA value at baseline and is defined as the percentage of patients having 2 consecutive PSA values (at least 3 weeks apart) that are at least 90% lower than baseline and that occur prior to PSA progression. PSA progression is defined as a = 25% increase and absolute increase of = 2 ng/mL above the nadir in PSA.
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Timepoint [5]
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PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.
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Secondary outcome [6]
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Radiologic Progression-free Survival (rPFS) by Gene in All Patients Per Central Independent Radiology Review (IRR)
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Assessment method [6]
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A secondary efficacy endpoint is Radiologic Progression-free Survival (rPFS) assessed by IRR. rPFS is defined as the time from first dose of rucaparib to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, plus 1 day. Radiographic disease progression includes confirmed bone disease progression and soft tissue disease progression adjudicated by IRR using the PCWG3 guidelines for bone disease and modified RECIST Version 1.1 for soft tissue disease.
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Timepoint [6]
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Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
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Secondary outcome [7]
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Radiologic Progression-free Survival (rPFS) by Gene in All Patients Per Investigator
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Assessment method [7]
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A secondary efficacy endpoint is Radiologic Progression-free Survival (rPFS) assessed by Investigator. rPFS is defined as the time from first dose of rucaparib to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, plus 1 day. Radiographic disease progression includes confirmed bone disease progression and soft tissue disease progression using the PCWG3 guidelines for bone disease and modified RECIST Version 1.1 for soft tissue disease.
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Timepoint [7]
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Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
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Secondary outcome [8]
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Overall Survival (OS) by Gene
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Assessment method [8]
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A secondary efficacy endpoint is Overall Survival (OS). OS is defined as the date from first dose of rucaparib to the date of death due to any cause, +1 day.
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Timepoint [8]
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From date of first dose until event, loss to follow-up, withdrawal of consent, or study closure: an overall median of approximately 33.1 months
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Secondary outcome [9]
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Clinical Benefit Rate (CBR) by Gene Per Central Independent Radiology Review (IRR)
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Assessment method [9]
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A secondary efficacy endpoint is Clinical Benefit Rate (CBR) assessed by IRR. CBR is defined as the number of patients without radiographic progression (defined by modified RECIST Version 1.1/ PCWG3 criteria) who were continuing with study drug treatment through the given time interval divided by the number of patients who had the given amount of follow-up. Clinical benefit rates are summarized at 6 and 12 months.
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Timepoint [9]
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Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
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Secondary outcome [10]
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Clinical Benefit Rate (CBR) by Gene Per Investigator
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Assessment method [10]
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A secondary efficacy endpoint is Clinical Benefit Rate (CBR) assessed by Investigator. CBR is defined as the number of patients without radiographic progression (defined by modified RECIST Version 1.1/ PCWG3 criteria) who were continuing with study drug treatment through the given time interval divided by the number of patients who had the given amount of follow-up. Clinical benefit rates are summarized at 6 and 12 months.
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Timepoint [10]
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Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
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Secondary outcome [11]
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Time to PSA Progression by Gene
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Assessment method [11]
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A secondary efficacy endpoint is time to PSA progession. Time to PSA progression is defined as the time from first dose of rucaparib to the date that a = 25% increase and absolute increase of = 2 ng/mL above the nadir (or baseline if there was no PSA decline after baseline) in PSA was measured, plus 1 day. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later (unless the PSA progression occurred at the last recorded PSA assessment). If confirmed, the date used for time of PSA progression is the earlier of the 2 PSA dates.
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Timepoint [11]
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PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.
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Secondary outcome [12]
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Steady State Trough (Cmin) Level Rucaparib Concentrations
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Assessment method [12]
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Trough (Cmin) concentrations of rucaparib are summarized for all patients with at least one PK sample collected. The absolute values of rucaparib plasma concentration at each time point are presented by gene.
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Timepoint [12]
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Participants were assessed at Study Day 29, Day 57, Day 85 and Day 113
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
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, 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Single group
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
15/02/2017
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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
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Actual
27/07/2021
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Sample size
Target
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Accrual to date
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Final
277
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Recruitment in Australia
Recruitment state(s)
NSW,TAS,VIC
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Recruitment hospital [1]
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Northern Cancer Insitute, St. Leonards - Saint Leonards
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Royal Hobart Hospital - Hobart
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Peninsula & Southeast Oncology - Frankston
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Barwon Health, University Hospital Geelong - Geelong
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Cabrini Hospital - Malvern
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Southside Cancer Care Centre - Miranda
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Orange Health Services - Orange
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St John of God Hospital, Subiaco - Subiaco
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Recruitment hospital [9]
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Riverina Cancer Care Centre - Wagga Wagga
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Recruitment postcode(s) [1]
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2065 - Saint Leonards
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7000 - Hobart
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3199 - Frankston
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3220 - Geelong
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3144 - Malvern
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2228 - Miranda
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2800 - Orange
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6008 - Subiaco
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Recruitment postcode(s) [9]
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2650 - Wagga Wagga
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Recruitment outside Australia
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Arezzo
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Guadalajara
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Country [79]
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0
Spain
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State/province [79]
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0
Lugo
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Country [80]
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0
Spain
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State/province [80]
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Madrid
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Country [81]
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Spain
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State/province [81]
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Oviedo
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Country [82]
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0
Spain
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State/province [82]
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0
Sabadell
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Country [83]
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0
Spain
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State/province [83]
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0
Santander
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Country [84]
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0
Spain
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State/province [84]
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0
Sevilla
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Country [85]
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Spain
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State/province [85]
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Valencia
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Country [86]
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United Kingdom
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State/province [86]
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Berkshire
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Country [87]
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United Kingdom
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State/province [87]
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England
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Country [88]
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United Kingdom
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State/province [88]
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Surrey
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Country [89]
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United Kingdom
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State/province [89]
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Headington
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Country [90]
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United Kingdom
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State/province [90]
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Liverpool
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Country [91]
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United Kingdom
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State/province [91]
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London
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Country [92]
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United Kingdom
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State/province [92]
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Southampton
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Country [93]
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United Kingdom
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State/province [93]
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Taunton
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Country [94]
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United Kingdom
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State/province [94]
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Wirral
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
pharmaand GmbH
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Foundation Medicine
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Address [1]
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0
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Country [1]
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0
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02952534
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02952534
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