Olaparib Real-world Utilization and Clinical Outcomes in France, Italy, and the UK
OVAL-1
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
1 other identifier
observational
342
3 countries
55
Brief Summary
This is a retrospective observational medical records review study of BRCA mutated advanced (FIGO stage III-IV) ovarian cancer patients who received first dose maintenance olaparib in 1L setting in France, Italy and the UK. Physicians who treated ovarian cancer patients with olaparib in 1L setting will be requested to recruit patients to have their clinical data abstracted from their clinical records in line with local laws
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Typical duration for all trials
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2020
CompletedFirst Posted
Study publicly available on registry
August 31, 2020
CompletedStudy Start
First participant enrolled
January 7, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2024
CompletedSeptember 23, 2025
September 1, 2025
3.7 years
August 26, 2020
September 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression
Progression-free survival (PFS)
36 months
Secondary Outcomes (1)
Overall Survival
36 months
Study Arms (1)
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
Interventions
Eligibility Criteria
• Patients with BRCA mutated advanced (FIGO stage III-IV) ovarian cancer treated with olaparib in first-line maintenance setting
You may qualify if:
- Patients with newly diagnosed, histologically confirmed, advanced (FIGO stage III - IV) epithelial ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer who have completed first line platinum-based chemotherapy, in PR/CR and treated with at least one dose of olaparib in first line maintenance setting
- Patients aged ≥18 years old
- Ability and/or willingness to provide a signed informed consent form (where required)
You may not qualify if:
- Withdrawal of informed consent (where consent required)
- Concurrent participation in any clinical study with an investigational product at the time of olaparib initiation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (55)
Research Site
Avignon, 84918, France
Research Site
Besançon, 25000, France
Research Site
Bordeaux, 33000, France
Research Site
Bourg-en-Bresse, 1012, France
Research Site
Calais, 62100, France
Research Site
Chambray-lès-Tours, 37175, France
Research Site
Epagny Metz-Tessy, 74370, France
Research Site
Grenoble, 38000, France
Research Site
Langon, 33210, France
Research Site
Lyon, 69004, France
Research Site
Nancy, 54000, France
Research Site
Paris, 75014, France
Research Site
Pierre-BĂ©nite, 69310, France
Research Site
Roubaix, 59100, France
Research Site
Saint-Cloud, 92210, France
Research Site
Saint-Grégoire, 35760, France
Research Site
Suresnes, 92150, France
Research Site
Tours, 37000, France
Research Site
Villejuif, 94800, France
Research Site
Acquaviva delle Fonti, 70021, Italy
Research Site
Aviano, 33081, Italy
Research Site
Bari, 70124, Italy
Research Site
Bologna, 40138, Italy
Research Site
Cagliari, 09121, Italy
Research Site
Catania, 95126, Italy
Research Site
Florence, 50134, Italy
Research Site
Genova, 16132, Italy
Research Site
Milan, 20133, Italy
Research Site
Milan, 20141, Italy
Research Site
Milan, 20162, Italy
Research Site
Modena, 41124, Italy
Research Site
Napoli, 80131, Italy
Research Site
Negrar, 37024, Italy
Research Site
Parma, 43126, Italy
Research Site
Roma, 00144, Italy
Research Site
Roma, 00168, Italy
Research Site
Torino, 10128, 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, EC1A7BE, United Kingdom
Research Site
London, NW12BU, United Kingdom
Research Site
London, SW36JJ, United Kingdom
Research Site
London, W120HS, 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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2020
First Posted
August 31, 2020
Study Start
January 7, 2021
Primary Completion
September 27, 2024
Study Completion
September 27, 2024
Last Updated
September 23, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF, CSR
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.