A Study to Characterize the Outcomes of Olaparib Maintenance Monotherapy in Newly Diagnosed BRCAwt Ovarian Cancer
FLAME
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
1 other identifier
observational
24
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2023
Shorter than P25 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 8, 2023
CompletedFirst Posted
Study publicly available on registry
March 20, 2023
CompletedStudy Start
First participant enrolled
July 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 27, 2023
CompletedSeptember 20, 2024
September 1, 2024
4 months
March 8, 2023
September 19, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical and Demographics characteristics
Clinical and Demographic characteristics including disease/FIGO stage, histology and tumor grade at initial Ovarian Cancer diagnosis, cancer antigen 125 (CA-125) level, Eastern Cooperative Oncology Group (ECOG) or other performance status, number and type of chemotherapy cycles, cytoreductive/debulking surgery type and outcomes, and selected comorbidities at index date will be described. Summary statistics will be used to describe the Demographics and clinical characteristics. The outcome will be measured for HRD+ patients.
At Index date - first olaparib prescription (Jan 2017 to Dec 2021)
Secondary Outcomes (3)
Real-world time to first subsequent treatment or death (rwTFST)
Jan 2017 to Jun 2023
Real-world time to treatment discontinuation or death (rwTTD)
Jan 2017 to Jun 2023
Number of patients with clinical event of interest (CEI)
Jan 2017 to Jun 2023
Study Arms (1)
Retrospective Cohort
Patients with newly diagnosed AOC BRCAwt with known HRD status who have been prescribed 1L olaparib maintenance treatment.
Interventions
Not Applicable since observational study
Eligibility Criteria
Patients with newly diagnosed AOC BRCAwt with available HRD status who have been prescribed 1L olaparib maintenance treatment.
You may qualify if:
- 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
You may not qualify if:
- Received another poly adenosine diphosphate ribose polymerase (PARP) inhibitor or bevacizumab before or while prescribed olaparib
- Participation in an interventional clinical study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (7)
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
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2023
First Posted
March 20, 2023
Study Start
July 10, 2023
Primary Completion
October 27, 2023
Study Completion
October 27, 2023
Last Updated
September 20, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.