Roll Over Study for Patients Who Have Completed a Previous Oncology Study with Olaparib

Phase 1

• Conditions: BRCA Mutated Ovarian Cancer Patients, Epithelian ovarian cancer, Metastatic Breast Cancer; MedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10033128Term: Ovarian cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-003777-26-SI
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-22
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 204

Inclusion Criteria

1 Provision of signed and dated, written ICF.
2 Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment in an AZ parent study using an AstraZeneca (AZ) compound that has met its endpoints or has otherwise stopped.
3 Patient participating in a prior oncology study with an AZ compound in which they received olaparib and are continuing to receive clinical benefit from treatment; the prior study can be an open-label or blinded study, with unblinding at study close.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 97
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 107

Exclusion Criteria

1 Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
2 Currently receiving treatment with any prohibited medication(s).
3 Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
4 Permanent discontinuation from the parent study due to toxicity or disease progression.
5 Local access to commercially-available drug at no cost to the patient is permitted by local regulation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified