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

Advanced Ovarian Cancer Clinical Trial

— FLAME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05775549
• Other study ID #: D0818R00008
• Status: Completed
• Start date: July 10, 2023
• Est. completion date: October 27, 2023

Study information

• Verified date: November 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 27, 2023
• Est. primary completion date: October 27, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Ovarian Cancer
• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms

Intervention

Other:
• None (Observational Study)
Not Applicable since observational study

Locations

Country	Name	City	State
United States	Research Site	Annapolis	Maryland
United States	Research Site	Baltimore	Maryland
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Madison	Wisconsin
United States	Research Site	New York	New York
United States	Research Site	Shreveport	Louisiana
United States	Research Site	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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