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NCT Number: NCT05775549

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

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Key information

Conditions

Advanced Ovarian Cancer

Age range

18 year–130 year

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Tampa, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

None (Observational study)

Other

Not Applicable since observational study

Other names: Observational Study

Primary outcomes

  1. Clinical and Demographics characteristics

    Time frame: At Index date - first olaparib prescription (Jan 2017 to Dec 2021)

    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.

Secondary outcomes

  1. Real-world time to first subsequent treatment or death (rwTFST)

    Time frame: Jan 2017 to Jun 2023

    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.

  2. Real-world time to treatment discontinuation or death (rwTTD)

    Time frame: Jan 2017 to Jun 2023

    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.

  3. Number of patients with clinical event of interest (CEI)

    Time frame: Jan 2017 to Jun 2023

    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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Acronym: FLAME

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 20, 2023
Registry last updated
Sep 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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