Olaparib Real-world Utilization and Clinical Outcomes in France, Italy, and the UK (OVAL-1)
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|ClinicalTrials.gov Identifier: NCT04532645|
Recruitment Status : Recruiting
First Posted : August 31, 2020
Last Update Posted : June 13, 2022
|Condition or disease||Intervention/treatment|
|Ovary Cancer||Drug: Olaparib|
- To estimate progression-free survival (PFS) in patients with BRCA-mutated advanced ovarian cancer treated with olaparib tablets in real-world first line maintenance setting.
- To describe olaparib treatment patterns (dosage; frequency of: dosage changes, dose interruptions, treatment cessation) in patients with BRCA-mutated advanced ovarian cancer treated in real-world first line maintenance setting.
- To estimate overall survival (OS) in patients with BRCA-mutated advanced ovarian cancer treated with olaparib tablets in real-world first line maintenance setting.
- To describe reasons for olaparib dosage changes, dose interruptions and treatment cessation in patients with BRCA-mutated advanced ovarian cancer treated in real-world first line maintenance setting
- To describe surgical and chemotherapy outcomes (PR/CR) in patients with BRCA-mutated advanced ovarian cancer before initiation of real-world first line maintenance olaparib tablets
- To describe response rate (RR) to olaparib tablets in patients with BRCA-mutated ovarian cancer with partial response to real-world first line chemotherapy.
- To describe treatment patterns and clinical outcomes in patients with BRCA-mutated advanced ovarian cancer who progressed during olaparib real-world first line maintenance therapy (including frequency of treatment interruptions, dosage reductions and treatment discontinuations and reasons associated with patterns)
- To estimate second progression-free survival (PFS2) in patients with BRCA-mutated ovarian cancer who progress while on olaparib real-world first line maintenance therapy.
- To describe healthcare resource utilisation in patients with BRCA-mutated advanced ovarian cancer treated with olaparib in real-world first line setting.
|Study Type :||Observational|
|Estimated Enrollment :||350 participants|
|Official Title:||A Pan-European Non-interventional, Retrospective Observational Cohort Study of Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Treated With Olaparib Tablets in the First-line Maintenance Setting|
|Actual Study Start Date :||December 11, 2020|
|Estimated Primary Completion Date :||December 31, 2024|
|Estimated Study Completion Date :||December 31, 2024|
Patients with BRCA mutated ovarian cancer
BRCA mutated advanced (FIGO stage III-IV) ovarian cancer patients who received first dose maintenance olaparib in 1L setting
Other Name: Lynparza
- Progression [ Time Frame: 36 months ]Progression-free survival (PFS)
- Overall Survival [ Time Frame: 36 months ]Overall survival over 36 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04532645
|Contact: Sanjoy Ketan Paul, Professoremail@example.com|
|Contact: Angela Whittlefirstname.lastname@example.org|
|Principal Investigator:||Charlie Gourley, MD, PhD||University of Edinburgh|
|Principal Investigator:||Domenica Lorusso, MD||Fondazione Policlinico Universitario Agostino Gemelli IRCCS|
|Principal Investigator:||Delphine Garbay, MD||Institut Bergonie, France|