Trial record 1 of 2 for:
triton | Prostate Cancer
A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON2)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02952534 |
Recruitment Status :
Active, not recruiting
First Posted : November 2, 2016
Last Update Posted : November 27, 2020
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Sponsor:
Clovis Oncology, Inc.
Collaborator:
Foundation Medicine
Information provided by (Responsible Party):
Clovis Oncology, Inc.
Tracking Information | |||||
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First Submitted Date ICMJE | October 24, 2016 | ||||
First Posted Date ICMJE | November 2, 2016 | ||||
Last Update Posted Date | November 27, 2020 | ||||
Actual Study Start Date ICMJE | February 15, 2017 | ||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency | ||||
Official Title ICMJE | TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency | ||||
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. | ||||
Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Metastatic Castration Resistant Prostate Cancer | ||||
Intervention ICMJE | Drug: Rucaparib
Rucaparib will be administered daily
Other Name: CO-338
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Study Arms ICMJE | Experimental: Rucaparib
Oral rucaparib (monotherapy)
Intervention: Drug: Rucaparib
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
360 | ||||
Original Estimated Enrollment ICMJE |
160 | ||||
Estimated Study Completion Date ICMJE | June 2021 | ||||
Estimated Primary Completion Date | June 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Australia, Belgium, Canada, Denmark, France, Germany, Ireland, Israel, Italy, Spain, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02952534 | ||||
Other Study ID Numbers ICMJE | CO-338-052 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Clovis Oncology, Inc. | ||||
Study Sponsor ICMJE | Clovis Oncology, Inc. | ||||
Collaborators ICMJE | Foundation Medicine | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Clovis Oncology, Inc. | ||||
Verification Date | November 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |