A Study of Olaparib and Durvalumab in Prostate Cancer
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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: NCT03810105 |
Recruitment Status :
Active, not recruiting
First Posted : January 18, 2019
Last Update Posted : March 31, 2022
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Sponsor:
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Tracking Information | |||||||||
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First Submitted Date ICMJE | January 17, 2019 | ||||||||
First Posted Date ICMJE | January 18, 2019 | ||||||||
Last Update Posted Date | March 31, 2022 | ||||||||
Actual Study Start Date ICMJE | March 7, 2019 | ||||||||
Estimated Primary Completion Date | February 2023 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Therapeutic efficacy as defined by number of participants with an undetectable PSA [ Time Frame: 1 year ] To assess the therapeutic efficacy as defined by an undetectable PSA (<0.05 or PSA <0.10 for institutions where this is the lower limit of detection) with non-castrate levels of testosterone using the combination olaparib (PARP inhibition) with durvalumab (PDL1 inhibition) at 24 months (cycle 24) in biochemically recurrent prostate cancer
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Original Primary Outcome Measures ICMJE |
Therapeutic efficacy as defined by an undetectable PSA [ Time Frame: 1 year ] To assess the therapeutic efficacy as defined by an undetectable PSA (<0.05 or PSA <0.10 for institutions where this is the lower limit of detection) with non-castrate levels of testosterone using the combination olaparib (PARP inhibition) with durvalumab (PDL1 inhibition) at 24 months (cycle 24) in biochemically recurrent prostate cancer
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A Study of Olaparib and Durvalumab in Prostate Cancer | ||||||||
Official Title ICMJE | A Phase II Study of Olaparib and Durvalumab in Men With Castration Sensitive Biochemically Recurrent Non-Metastatic Prostate Cancer Harboring Mutations in DNA Damage Repair | ||||||||
Brief Summary | The purpose of this study is to determine if the combination of olaparib and durvalumab are better than the standard of care for treating prostate cancer. | ||||||||
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 | Prostate Cancer | ||||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Castration Sensitive Biochemically Recurrent Prostate Cancer
Castration Sensitive Biochemically Recurrent Non-Metastatic Prostate Cancer
Interventions:
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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 | ||||||||
Actual Enrollment ICMJE |
5 | ||||||||
Original Estimated Enrollment ICMJE |
32 | ||||||||
Estimated Study Completion Date ICMJE | February 2023 | ||||||||
Estimated Primary Completion Date | February 2023 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
NOTE: HIPAA authorization may be either included in the informed consent or obtained separately.
Exclusion Criteria:
intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection); Systemic corticosteroids at physiologic doses not to exceed 10 mg/day ofprednisone or its equivalent; Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
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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 | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03810105 | ||||||||
Other Study ID Numbers ICMJE | 18-480 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Memorial Sloan Kettering Cancer Center | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Memorial Sloan Kettering Cancer Center | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Memorial Sloan Kettering Cancer Center | ||||||||
Verification Date | March 2022 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |