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

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Conditions studied: Ovarian Cancer

In brief

This is an open-label, single-arm, international, multicenter Multiple Patient Expanded Access Program (MPEAP). The program is designed to provide treatment access to olaparib tablets for patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer without other treatment options or eligible for an olaparib clinical trials.

Key facts

Study ID

NCT03079687

Run by

AstraZeneca

Last updated by the study team

2017-10-25

Who can join

Age: 18 and older, up to 120. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Duarte, California, United States
• Research Site — Newport Beach, California, United States
• Research Site — Roseville, California, United States
• Research Site — Gainesville, Florida, United States
• Research Site — Scarborough, Maine, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Rochester, Minnesota, United States
• Research Site — Columbia, Missouri, United States
• Research Site — Albuquerque, New Mexico, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Winston-Salem, North Carolina, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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