Expanded Access Program for Olaparib Tablets as Maintenance Therapy in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
Sponsor: AstraZeneca
ClinicalTrials ID:NCT03079687
This open-label, single-arm program provides olaparib tablets (300 mg twice daily) to patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer in response to platinum-based chemotherapy. Eligibility requires informed consent, normal organ function, and non-childbearing status. Exclusions include hypersensitivity to olaparib and certain drug interactions.
Patient Parameters
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Program Overview
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.
Description
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.
Eligibility Criteria
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.
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