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

AstraZeneca

Status: Active, not recruiting

Conditions: Ovary Cancer

Treatments: Drug: Olaparib

Study type: Observational

Funder types: Industry

Identifiers

NCT04532645

D0817R00019

Details and patient eligibility

About

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

Full 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

Enrollment: 350 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

350 participants in 1 patient group

Patients with BRCA mutated ovarian cancer

Description:

BRCA mutated advanced (FIGO stage III-IV) ovarian cancer patients who received first dose maintenance olaparib in 1L setting

Treatment:

Drug: Olaparib