Olaparib Real-world Utilization and Clinical Outcomes in France, Italy, and the UK (OVAL-1)

October 9, 2023 updated by: AstraZeneca

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Primary Objective(s)

  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

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avignon, France, 84918
        • Research Site
      • Besancon, France
        • Research Site
      • Bordeaux, France
        • Research Site
      • Bordeaux, France, 33000
        • Research Site
      • Bourg-en-Bresse, France, 01012
        • Research Site
      • Brest, France, 29200
        • Research Site
      • Calais, France, 62100
        • Research Site
      • Chalon-sur-Saone, France, 71321
        • Research Site
      • Chambray-les-Tours, France
        • Research Site
      • Dijon, France, 21000
        • Research Site
      • Epagny Metz-Tessy, France
        • Research Site
      • Grenoble, France, 38000
        • Research Site
      • Langon, France, 33210
        • Research Site
      • Le Coudray, France
        • Research Site
      • Lille, France, 59000
        • Research Site
      • Lille, France
        • Research Site
      • Limoges, France, 87000
        • Research Site
      • Lyon, France
        • Research Site
      • Marseille, France, 13009
        • Research Site
      • Nancy, France
        • Research Site
      • Paris, France
        • Research Site
      • Paris, France, 75014
        • Research Site
      • Paris, France, 75960
        • Research Site
      • Pierre-Benite, France
        • Research Site
      • Pontoise, France, 95300
        • Research Site
      • Rennes, France
        • Research Site
      • Roubaix, France
        • Research Site
      • Saint-Cloud, France
        • Research Site
      • Saint-Gregoire, France, 35760
        • Research Site
      • Sainte Clotilde - La Reunion, France
        • Research Site
      • Strasbourg, France
        • Research Site
      • Suresnes, France
        • Research Site
      • Tours, France, 37000
        • Research Site
      • Valenciennes, France, 59300
        • Research Site
      • Vandoeuvre-les-Nancy, France, 54519
        • Research Site
      • Villejuif, France
        • Research Site
    • La Réunion (oversea France)
      • Saint Pierre, La Réunion (oversea France), France, 97410
        • Research Site
  • United Kingdom
      • Edinburgh, United Kingdom
        • Research Site
      • Glasgow, United Kingdom
        • Research Site
      • Leeds, United Kingdom
        • Research Site
      • Liverpool, United Kingdom
        • Research Site
      • London, United Kingdom, SW36JJ
        • Research Site
      • London, United Kingdom, EC1A7BE
        • Research Site
      • London, United Kingdom, NW12BU
        • Research Site
      • London, United Kingdom, W120HS
        • Research Site
      • Maidstone, United Kingdom
        • Research Site
      • Manchester, United Kingdom
        • Research Site
      • Newcastle, United Kingdom
        • Research Site
      • Nottingham, United Kingdom
        • Research Site
      • Portsmouth, United Kingdom
        • Research Site
      • Surrey, United Kingdom
        • Research Site
      • Swansea, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

• Patients with BRCA mutated advanced (FIGO stage III-IV) ovarian cancer treated with olaparib in first-line maintenance setting

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Withdrawal of informed consent (where consent required)
  • Concurrent participation in any clinical study with an investigational product at the time of olaparib initiation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Drug: Olaparib
Olaparib
Other Names:
  • Lynparza

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression
Time Frame: 36 months
Progression-free survival (PFS)
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: 36 months
Overall survival over 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2020

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

August 26, 2020

First Submitted That Met QC Criteria

August 26, 2020

First Posted (Actual)

August 31, 2020

Study Record Updates

Last Update Posted (Actual)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 9, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D0817R00019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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