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, Platinum Sensitive Relapsed Ovarian Cancer, Patients with gBRCA mutated metastatic pancreatic cancer, prostate cancer, endometrium cancer; MedDRA version: 27.0Level: LLTClassification code: 10033605Term: Pancreatic cancer metastatic Class: 10029104; MedDRA version: 21.0Level: PTClassification code: 10014733Term: Endometrial cancer Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10006187Term: Breast cancer Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10060862Term: Prostate cancer Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10016180Term: Fallopian tube cancer Class: 100000004864; MedDRA version: 20.0Level: PTClassification code: 10033128Term: Ovarian cancer Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-512982-15-00
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-16
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 147

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.

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 (increase in the severity of the disease under study and/or increases in the symptoms of a patient's condition attributable to the disease, as assessed and documented by the Investigator. Physician-defined progression can be radiological [eg, RECIST] progression or clinical progression)., 5 Local access to commercially-available drug at no cost to the patient, as permitted by local/country regulation.

Study & Design

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