Ovary CancerOVAL-1NCT04532645
Olaparib Real-world Utilization and Clinical Outcomes in France, Italy, and the UK
An observational study of Ovary Cancer, run by AstraZeneca at 55 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovary Cancer
- What is being tested?
- Olaparib
- Type of treatment
- Injection or infusion
- How many people
- 342 participants
- Where
- 55 sitesin 3 countries
- Study dates
- 7 Jan 2021to 27 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: • Patients with BRCA mutated advanced (FIGO stage III-IV) ovarian cancer treated with olaparib in first-line maintenance setting
Who may be able to join
- 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)
Who cannot join
- Withdrawal of informed consent (where consent required)
- Concurrent participation in any clinical study with an investigational product at the time of olaparib initiation
Trial locations and contacts
55 sites in 3 countries.
55 sites in 3 countries
France19 sites
Research Site
Avignon, 84918
Research Site
Besançon, 25000
Research Site
Bordeaux, 33000
Research Site
Bourg-en-Bresse, 1012
Research Site
Calais, 62100
Research Site
Chambray-lès-Tours, 37175
Research Site
Epagny Metz-Tessy, 74370
Research Site
Grenoble, 38000
Research Site
Langon, 33210
Research Site
Lyon, 69004
Research Site
Nancy, 54000
Research Site
Paris, 75014
Research Site
Pierre-Bénite, 69310
Research Site
Roubaix, 59100
Research Site
Saint-Cloud, 92210
Research Site
Saint-Grégoire, 35760
Research Site
Suresnes, 92150
Research Site
Tours, 37000
Research Site
Villejuif, 94800
Italy18 sites
Research Site
Acquaviva delle Fonti, 70021
Research Site
Aviano, 33081
Research Site
Bari, 70124
Research Site
Bologna, 40138
Research Site
Cagliari, 09121
Research Site
Catania, 95126
Research Site
Florence, 50134
Research Site
Genova, 16132
Research Site
Milan, 20133
Research Site
Milan, 20141
Research Site
Milan, 20162
Research Site
Modena, 41124
Research Site
Naples, 80131
Research Site
Negrar, 37024
Research Site
Parma, 43126
Research Site
Roma, 00144
Research Site
Roma, 00168
Research Site
Torino, 10128
United Kingdom18 sites
Research Site
Birmingham
Research Site
Cambridge
Research Site
Ediburgh
Research Site
Glasgow
Research Site
Guildford
Research Site
Leeds
Research Site
Liverpool
Research Site
London, EC1A7BE
Research Site
London, NW12BU
Research Site
London, SW36JJ
Research Site
London, W120HS
Research Site
Maidstone
Research Site
Manchester
Research Site
Newcastle
Research Site
Northampton
Research Site
Nottingham
Research Site
Portsmouth
Research Site
Swansea
About this study
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
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
Read the detailed description
Primary Objective(s)
- 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.
Secondary Objective(s)
- 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
- Conditions
- Ovary Cancer
- Being tested
- Olaparib
- Keywords
- Ovary cancer, Ovarian neoplasm, BRCA mutated advanced (FIGO stage III-IV) ovarian cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OlaparibDrug
Also called Lynparza
Olaparib
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Olaparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression
Progression-free survival (PFS)
Measured: 36 months
Secondary outcomes (1)
Overall Survival
Overall survival over 36 months
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start7 Jan 2021
- Primary completion27 Sep 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovary CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charlie Gourley, MD, PhD, Principal investigator, University of EdinburghDomenica Lorusso, MD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCSDelphine Garbay, MD, Principal investigator, Institut Bergonie, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532645
- Sponsor's protocol ID
- D0817R00019
- Acronym
- OVAL-1
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2020
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04532645
- Acronym / sponsor ID
- OVAL-1 / D0817R00019
- Conditions
- Ovary Cancer
- Keywords
- Ovary cancer, Ovarian neoplasm, BRCA mutated advanced (FIGO stage III-IV) ovarian cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Primary Objective(s)
- 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.
Secondary Objective(s)
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with BRCA mutated ovarian cancer | – | Drug: OlaparibBRCA mutated advanced (FIGO stage III-IV) ovarian cancer patients who received first dose maintenance olaparib in 1L setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- • Patients with BRCA mutated advanced (FIGO stage III-IV) ovarian cancer treated with olaparib in first-line maintenance setting
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Withdrawal of informed consent (where consent required)
- Concurrent participation in any clinical study with an investigational product at the time of olaparib initiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OlaparibAlso: LynparzaOlaparib | Drug | Patients with BRCA mutated ovarian cancer |
Primary outcome
Progression
Time frame: 36 months
Progression-free survival (PFS)
1 secondary outcome
Overall Survival
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- CSR synopsis redactedLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlie Gourley, MD, PhD principal investigator
University of Edinburgh
Domenica Lorusso, MD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Delphine Garbay, MD principal investigator
Institut Bergonie, France
55 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovary Cancer, run by AstraZeneca at 55 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in France, Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.