Clinical trial · Observational
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
NCT05775549CI-TRIAL-00080919FLAMEcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| None (Observational Study) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Retrospective Cohort
- description
- Patients with newly diagnosed AOC BRCAwt with known HRD status who have been prescribed 1L olaparib maintenance treatment.
- interventionNames
- Other: None (Observational Study)
Primary outcomes (1)
- measure
- Clinical and Demographics characteristics
- timeFrame
- At Index date - first olaparib prescription (Jan 2017 to Dec 2021)
- description
- 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 (3)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 130 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.