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

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.

Study Overview

• Status: Completed
• Conditions: Advanced Ovarian Cancer
• Intervention / Treatment: Other: None (Observational Study)

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.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with newly diagnosed AOC BRCAwt with available HRD status who have been prescribed 1L olaparib maintenance treatment.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective Cohort; Patients with newly diagnosed AOC BRCAwt with known HRD status who have been prescribed 1L olaparib maintenance treatment.	Other: None (Observational Study); Not Applicable since observational study; Other Names: Observational Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real-world time to treatment discontinuation or death (rwTTD)	rwTTD is defined as the time from the index date to the earliest of the date of death or discontinuation of olaparib. The outcome will be measured for HRD+ patients.	Jan 2017 to Jun 2023
Number of patients with clinical event of interest (CEI)	To summarize the real-world safety and tolerability profile based on pre-specified CEIs of 1L olaparib maintenance monotherapy in BRCAwt newly diagnosed AOC patients regardless of HRD status.	Jan 2017 to Jun 2023
Real-world time to first subsequent treatment or death (rwTFST)	rwTFST is defined as the time from the index date (date of the first olaparib prescription) to the earliest of the date of death or commencement of first subsequent anticancer treatment. The outcome will be measured for HRD+ patients.	Jan 2017 to Jun 2023

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• CSR Synopsis_Redacted

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2023
• Primary Completion (Actual): October 27, 2023
• Study Completion (Actual): October 27, 2023

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 20, 2023

Study Record Updates

• Last Update Posted (Actual): September 20, 2024
• Last Update Submitted That Met QC Criteria: September 19, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Homologous recombination deficiency; Real-world evidence; breast cancer gene; breast cancer gene mutated; breast cancer gene wild type
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: D0818R00008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing 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.
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No