Expanded Access Program for olaparib tablets as maintenance therapy in patients with ovarian, fallopian tube or primary peritoneal cancer.

Exclusion Criteria

• Inclusion criteria
• For inclusion in the program patients must fulfill the following criteria:
• • Provision of informed consent prior to any program specific procedures
• • Female patients ≥ 18 years of age and has platinum-sensitive relapsed high grade epithelial ovarian, primary peritoneal or fallopian tube cancer
• • Patient is in response (complete response or partial response) following platinum-based chemotherapy.
• • Patients must have normal organ and bone marrow function measured within 28 days prior to administration of program treatment.
• • Postmenopausal or evidence of non-childbearing status for women of childbearing potential.
• Patients should not enter the program if any of the following exclusion criteria are fulfilled:
• • Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
• • Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors.
• • Concomitant use of known strong or moderate CYP3A inducers. The required washout period prior to starting olaparib is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents.
• • Patient with moderate or severe hepatic impairment.
• • Breast feeding women.