A Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy in Newly Diagnosed BRCAwt Ovarian Cancer
NCT ID: NCT05775549
Last Updated: 2024-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
24 participants
OBSERVATIONAL
2023-07-10
2023-10-27
Brief Summary
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Detailed Description
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In this observational study, it is planned to include approximately 150 US female patients with newly diagnosed advanced ovarian cancer (AOC) who were tumor biomarker tested between first diagnosis with AOC and first prescription of 1L olaparib maintenance monotherapy as tumor breast cancer gene wild type (BRCAwt) with a known homologous recombination deficiency (HRD) status.
This retrospective cohort study will include patients with first olaparib prescription between Jan 2017 and Dec 2021. All data collection will be retrospective. Data will be collected from the date of first olaparib prescription (index date) with a follow-up period of at least 18 months post index date.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Retrospective Cohort
Patients with newly diagnosed AOC BRCAwt with known HRD status who have been prescribed 1L olaparib maintenance treatment.
None (Observational Study)
Not Applicable since observational study
Interventions
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None (Observational Study)
Not Applicable since observational study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BRCAwt AOC diagnosed with any approved BRCA test
* Has documented HRD status based on available test results
* Received 1L olaparib maintenance monotherapy following platinum chemotherapy
* Patients must have been treated with platinum-based chemotherapy at first-line
Exclusion Criteria
* Participation in an interventional clinical study
18 Years
130 Years
FEMALE
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Tampa, Florida, United States
Research Site
Shreveport, Louisiana, United States
Research Site
Annapolis, Maryland, United States
Research Site
Baltimore, Maryland, United States
Research Site
New York, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Madison, Wisconsin, United States
Countries
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Related Links
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Other Identifiers
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D0818R00008
Identifier Type: -
Identifier Source: org_study_id
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