Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments

• Status: Active, not recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: Female

Summary

Comparison of olaparib vs. physician's choice of single agent standard of care non-platinum based chemotherapy in patients with germline Breast Cancer susceptibility gene (gBRCA) mutated ovarian cancer who have progressed at least 6 months after the last platinum based chemotherapy. Patient should have received at least 2 prior lines of platinum based chemotherapy. The aim of the study is to assess the efficacy and safety of olaparib tablets.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Collaborators: Merck Sharp & Dohme Corp.; Myriad Genetic Laboratories, Inc.
• Treatments: Olaparib

Criteria

Inclusion Criteria:

• Patients must be ≥ 18 years of age

• Patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer. Patients are eligible to undergo BRCA testing even if they have not yet had recurrence or progression of disease >6 months (>/=183 days) after completion of their last platinum therapy.

• Documented germline mutation in Breast Cancer susceptibility genes: BRCA1 and/or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)

• At least one lesion that can be accurately assessed at baseline by CT/MRI and is suitable for repeated assessment.

• Patients must have received at least 2 prior platinum based lines of chemotherapy - Patients must be partially platinum sensitive or platinum sensitive

• Patients must be suitable to start treatment with single agent chemotherapy based on physician's choice

• Patients must have normal organ and bone marrow function measured within 28 days of randomisation,

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Patients must have a life expectancy ≥ 16 weeks

• Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing.

Exclusion Criteria:

• BRCA 1 and/or BRCA2 mutations that are considered to be non detrimental

• Exposure to any investigational product within 30 days or 5 half lives (whichever is longer) prior to randomisation

• Any previous treatment with a Polyadenosine 5'diphosphoribose polymerisation (PARP) inhibitor, including olaparib.

• Patients who have platinum resistant or refractory disease

• Patients receiving any systemic chemotherapy within 3 weeks prior to first dose of study treatment

• Previous single agent exposure to the selected chemotherapy regimen for randomisation.
• Prior malignancy in the last 5 years, unless curatively treated and recurrence free (few exceptions apply).