Expanded Access Program for Olaparib Tablets as Maintenance Therapy in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer.

This is an expanded access trial for Ovarian Cancer focused on measuring Ovarian cancer, gynaecological cancer, platinum-sensitive disease, platinum-sensitive relapsed, Olaparib, Ovarian Neoplasms, Neoplasms, Ovarian Disease, fallopean tube cancer, primary peritoneal cancer, epithelial ovarian cancer, PARP inhibitors, Poly (ADP-ribose) polymerase inhibitors. Read More

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.

Exclusion criteria:

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.