Olaparib Real-world Utilization and Clinical Outcomes in France, Italy, and the UK
NCT ID: NCT04532645
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
342 participants
OBSERVATIONAL
2021-01-07
2024-09-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Real-life Data of Olaparib in Relapsed Ovarian Cancers Patients
NCT04152941
Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.
NCT01844986
OSCA - Olaparib Standard of CAre Study
NCT02262273
Olaparib in Patients With Recurrent Ovarian Cancer Wild Type for Germline and Somatic BRCA 1 and 2 Genes: The MITO 31 Translational Study
NCT04091204
D9319C00001- 1L OC Mono Global RCT
NCT04884360
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. 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.
2. 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.
Secondary Objective(s)
1. To estimate overall survival (OS) in patients with BRCA-mutated advanced ovarian cancer treated with olaparib tablets in real-world first line maintenance setting.
2. 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
3. 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
4. To describe response rate (RR) to olaparib tablets in patients with BRCA-mutated ovarian cancer with partial response to real-world first line chemotherapy.
5. 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)
6. 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.
7. To describe healthcare resource utilisation in patients with BRCA-mutated advanced ovarian cancer treated with olaparib in real-world first line setting
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Olaparib
Olaparib
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Olaparib
Olaparib
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients aged ≥18 years old
* Ability and/or willingness to provide a signed informed consent form (where required)
Exclusion Criteria
* Concurrent participation in any clinical study with an investigational product at the time of olaparib initiation
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Charlie Gourley, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Edinburgh
Domenica Lorusso, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Delphine Garbay, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Bergonie, France
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Avignon, , France
Research Site
Besançon, , France
Research Site
Bordeaux, , France
Research Site
Bourg-en-Bresse, , France
Research Site
Calais, , France
Research Site
Chambray-lès-Tours, , France
Research Site
Epagny Metz-Tessy, , France
Research Site
Grenoble, , France
Research Site
Langon, , France
Research Site
Lyon, , France
Research Site
Nancy, , France
Research Site
Paris, , France
Research Site
Pierre-Bénite, , France
Research Site
Roubaix, , France
Research Site
Saint-Cloud, , France
Research Site
Saint-Grégoire, , France
Research Site
Suresnes, , France
Research Site
Tours, , France
Research Site
Villejuif, , France
Research Site
Acquaviva delle Fonti, , Italy
Research Site
Aviano, , Italy
Research Site
Bari, , Italy
Research Site
Bologna, , Italy
Research Site
Cagliari, , Italy
Research Site
Catania, , Italy
Research Site
Florence, , Italy
Research Site
Genova, , Italy
Research Site
Milan, , Italy
Research Site
Milan, , Italy
Research Site
Milan, , Italy
Research Site
Modena, , Italy
Research Site
Napoli, , Italy
Research Site
Negrar, , Italy
Research Site
Parma, , Italy
Research Site
Roma, , Italy
Research Site
Roma, , Italy
Research Site
Torino, , Italy
Research Site
Birmingham, , United Kingdom
Research Site
Cambridge, , United Kingdom
Research Site
Ediburgh, , United Kingdom
Research Site
Glasgow, , United Kingdom
Research Site
Guildford, , United Kingdom
Research Site
Leeds, , United Kingdom
Research Site
Liverpool, , United Kingdom
Research Site
London, , United Kingdom
Research Site
London, , United Kingdom
Research Site
London, , United Kingdom
Research Site
London, , United Kingdom
Research Site
Maidstone, , United Kingdom
Research Site
Manchester, , United Kingdom
Research Site
Newcastle, , United Kingdom
Research Site
Northampton, , United Kingdom
Research Site
Nottingham, , United Kingdom
Research Site
Portsmouth, , United Kingdom
Research Site
Swansea, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D0817R00019
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.