Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2
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ClinicalTrials.gov Identifier: NCT05482074 |
Recruitment Status :
Withdrawn
(Principal Investigator left the institute)
First Posted : August 1, 2022
Last Update Posted : January 19, 2024
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Tracking Information | |||||||||||||
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First Submitted Date ICMJE | July 27, 2022 | ||||||||||||
First Posted Date ICMJE | August 1, 2022 | ||||||||||||
Last Update Posted Date | January 19, 2024 | ||||||||||||
Estimated Study Start Date ICMJE | October 4, 2022 | ||||||||||||
Estimated Primary Completion Date | May 1, 2026 (Final data collection date for primary outcome measure) | ||||||||||||
Current Primary Outcome Measures ICMJE |
Overall response rate (ORR) [ Time Frame: 12 weeks ] Best overall response (CR+PR) assessed by RECIST v1.1
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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 | Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2 | ||||||||||||
Official Title ICMJE | Pilot Trial of Olaparib in Patients With Unresectable or Metastatic Melanoma With Mutations in BRCA1/2 Genes | ||||||||||||
Brief Summary | The purpose of this study is to evaluate how effective Olaparib is when given as a treatment for primary or recurrent, unresectable or metastatic melanoma. This research study involves targeted therapy. -The name of the study drug involved in this study is: Olaparib (also known as Lynparza) |
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Detailed Description | A phase II, single arm, open label pilot trial in a sample size of 15 primary or recurrent, unresectable or metastatic melanoma patients that have progressed on prior checkpoint inhibitor therapy with germline or somatic mutations in BRCA1/2. The research study procedures include screening for eligibility, study treatment including evaluations, surveys, optional biopsies, and follow up visits. This research study involves targeted therapy.
It is expected that about 15 people will take part in this research study. This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. This research study is a Pilot Study, which is the first time investigators are examining this drug for treatment of melanoma. The U.S. Food and Drug Administration (FDA) has not approved Olaparib for this specific disease, but it has been approved for other uses. AstraZeneca, a pharmaceutical company, is supporting this research study by providing funding for the research study and the study drug, Olaparib. |
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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 |
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Intervention ICMJE | Drug: Olaparib
Oral, twice a day, dosage per protocol, per 28 day cycle
Other Name: LYNPARZA
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Study Arms ICMJE | Experimental: OLAPARIB
The research study procedures include screening for eligibility, study treatment including evaluations, surveys, optional biopsies, and follow up visits Olaparib- Each study treatment cycle lasts 28 days . This will continue for as long as the study treatment is providing clinical benefit Intervention: Drug: Olaparib
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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 | Withdrawn | ||||||||||||
Actual Enrollment ICMJE |
0 | ||||||||||||
Original Estimated Enrollment ICMJE |
15 | ||||||||||||
Estimated Study Completion Date ICMJE | May 1, 2027 | ||||||||||||
Estimated Primary Completion Date | May 1, 2026 (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 | Not Provided | ||||||||||||
Removed Location Countries | United States | ||||||||||||
Administrative Information | |||||||||||||
NCT Number ICMJE | NCT05482074 | ||||||||||||
Other Study ID Numbers ICMJE | 22-294 | ||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Dana-Farber Cancer Institute | ||||||||||||
Original Responsible Party | Tamara Sussman, MD, Dana-Farber Cancer Institute, Principal Investigator | ||||||||||||
Current Study Sponsor ICMJE | Dana-Farber Cancer Institute | ||||||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||||||
Collaborators ICMJE | AstraZeneca | ||||||||||||
Investigators ICMJE |
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PRS Account | Dana-Farber Cancer Institute | ||||||||||||
Verification Date | January 2024 | ||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |