NCT05775549

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

FLAME - First Line olAparib Maintenance bEyond BRCA An Observational Cohort Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy Beyond BRCA Mutant Status in Newly Diagnosed Advanced Ovarian Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Advanced Ovarian Cancer

Interventions

Type	Name	Description
OTHER	None (Observational Study)	Not Applicable since observational study

Timeline

• Start date: 2023-07-10
• Primary completion: 2023-10-27
• Completion: 2023-10-27
• First posted: 2023-03-20
• Last updated: 2024-09-20

Locations

7 sites across 1 country: United States