Ovarian Cancer Clinical Trial

A Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy in Newly Diagnosed BRCAwt Ovarian Cancer

Summary

This study will collect the data from existing patient medical records at US cancer centers. The study will include patients with BRCAwt ovarian cancer who have been prescribed first line (1L) olaparib maintenance treatment.

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Full Description

This is a United States (US) based multicenter, retrospective, observational cohort study with data abstracted from patient medical records.

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Female adult, age ≥ 18 years
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:

Received another poly adenosine diphosphate ribose polymerase (PARP) inhibitor or bevacizumab before or while prescribed olaparib
Participation in an interventional clinical study

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

24

Study ID:

NCT05775549

Recruitment Status:

Completed

Sponsor:

AstraZeneca

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There are 7 Locations for this study

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Research Site
Tampa Florida, 33606, United States
Research Site
Shreveport Louisiana, 71103, United States
Research Site
Annapolis Maryland, 21401, United States
Research Site
Baltimore Maryland, 21287, United States
Research Site
New York New York, 10032, United States
Research Site
Charlotte North Carolina, 28204, United States
Research Site
Madison Wisconsin, 53792, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

24

Study ID:

NCT05775549

Recruitment Status:

Completed

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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