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

AstraZeneca

Status

Conditions: Ovarian Cancer

Treatments: Drug: Olaparib tablets

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03079687

D0816R00014

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

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.