Olaparib Maintenance Treatment Versus Placebo in Patients With PSR Ovarian Cancer Who Are in CR or PR to Platinum-based Chemotherapy and Whose Tumours Carry sBRCAm or HRR-associated Genes Mutations

Exclusion Criteria

• •Documented germline mutation in BRCA1 and/or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).
• •Patients who have had drainage of their ascites from the final 2 cycles of their last chemotherapy regimen prior to randomisation on the study
• •Participation in another clinical study with an investigational product during the chemotherapy course immediately prior to randomisation
• •Any previous treatment with a PARP inhibitor, including olaparib
• •Patients with a known hypersensitivity to olaparib or any of the excipients of the product
• •Prior malignancy in the last 5 years, unless curatively treated and recurrence free (few exceptions apply)
• •Patients receiving any systemic chemotherapy (including chemotherapy received as the most recent anticancer therapy) or radiotherapy (except for palliative reasons) within 3 weeks prior to study randomised treatment
• •Persistent toxicities (\>Common Terminology Criteria for Adverse Event (CTCAE) CTCAE grade 2) caused by previous cancer therapy, excluding CTCAE grade 2 peripheral neuropathy
• •Patients with myelodysplastic syndrome/acute myeloid leukaemia (t-AML) or with features suggestive of MDS/AML
• •Patients with symptomatic uncontrolled brain metastases
• •Major surgery within 2 weeks of starting study randomised treatment and patients must have recovered from any effects of any major surgery
• •Patients considered a poor medical risk