The Multiple Patient Expanded Access 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 who are in response (complete response or partial response) following platinum-based chemotherapy. The dose of olaparib tablets is 300 mg (two 150 mg tablets) taken twice daily, equivalent to a total daily dose of 600 mg. The 100 mg tablet is available for dose reduction. Treatment may continue until disease progression, unacceptable toxicity or withdrawal of patient consent. The program will collect observational data only.
Drug: Olaparib tablets
Patients will receive olaparib tablets 300mg (two 150mg tablets) twice daily.
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
- 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.
Duarte, California, 91010
Newport Beach, California, 92663
Roseville, California, 95661
Gainesville, Florida, 32608
Scarborough, Maine, 04074
Baltimore, Maryland, 21201
Rochester, Minnesota, 55905
Columbia, Missouri, 65212
Albuquerque, New Mexico, 87106
Durham, North Carolina, 27710
Winston-Salem, North Carolina, 27157-1023
Cleveland, Ohio, 44195
Portland, Oregon, 97239
Expanded Access program information for companies listed in the Expanded Access Company Directory is pulled daily from ClinicalTrials.gov, a resource provided by the National Institutes of Health in cooperation with the U.S. Food and Drug Administration. Click here for more information about ClinicalTrials.gov.