Olaparib Real-world Utilization and Clinical Outcomes in France, Italy, and the UK

Ovary Cancer Clinical Trial

— OVAL-1  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04532645
• Other study ID #: D0817R00019
• Status: Active, not recruiting
• Start date: December 11, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2023
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 350
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Neoplasms
• Ovary Cancer

Intervention

Drug:
• Olaparib
Olaparib

Locations

Country	Name	City	State
France	Research Site	Avignon
France	Research Site	Besancon
France	Research Site	Bordeaux
France	Research Site	Bordeaux
France	Research Site	Bourg-en-Bresse
France	Research Site	Brest
France	Research Site	Calais
France	Research Site	Chalon-sur-Saone
France	Research Site	Chambray-les-Tours
France	Research Site	Dijon
France	Research Site	Epagny Metz-Tessy
France	Research Site	Grenoble
France	Research Site	Langon
France	Research Site	Le Coudray
France	Research Site	Lille
France	Research Site	Lille
France	Research Site	Limoges
France	Research Site	Lyon
France	Research Site	Marseille
France	Research Site	Nancy
France	Research Site	Paris
France	Research Site	Paris
France	Research Site	Paris
France	Research Site	Pierre-Benite
France	Research Site	Pontoise
France	Research Site	Rennes
France	Research Site	Roubaix
France	Research Site	Saint Pierre	La Réunion (oversea France)
France	Research Site	Saint-Cloud
France	Research Site	Saint-Gregoire
France	Research Site	Sainte Clotilde - La Reunion
France	Research Site	Strasbourg
France	Research Site	Suresnes
France	Research Site	Tours
France	Research Site	Valenciennes
France	Research Site	Vandoeuvre-les-Nancy
France	Research Site	Villejuif
United Kingdom	Research Site	Edinburgh
United Kingdom	Research Site	Glasgow
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	Nottingham
United Kingdom	Research Site	Portsmouth
United Kingdom	Research Site	Surrey
United Kingdom	Research Site	Swansea

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

France,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression	Progression-free survival (PFS)	36 months
Secondary	Overall Survival	Overall survival over 36 months	36 months