Official Title
A Multiple Patient Expanded Access Program for Olaparib Tablets for the Maintenance Treatment Following Response (Complete Response or Partial Response) to Platinum-based Chemotherapy in Patients With Platinum-sensitive Relapsed High-grade Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
Brief Summary

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.

Detailed 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.

Approved for marketing
Treatment IND/Protocol
Ovarian Cancer

Drug: Olaparib tablets
Patients will receive olaparib tablets 300mg (two 150mg tablets) twice daily.

Eligibility 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.

Eligibility Gender
Female
Eligibility Age
Minimum: 18 Years~Maximum: 120 Years
Countries
United States
Locations

Research Site
Duarte, California, 91010

Research Site
Newport Beach, California, 92663

Research Site
Roseville, California, 95661

Research Site
Gainesville, Florida, 32608

Research Site
Scarborough, Maine, 04074

Research Site
Baltimore, Maryland, 21201

Research Site
Rochester, Minnesota, 55905

Research Site
Columbia, Missouri, 65212

Research Site
Albuquerque, New Mexico, 87106

Research Site
Durham, North Carolina, 27710

Research Site
Winston-Salem, North Carolina, 27157-1023

Research Site
Cleveland, Ohio, 44195

Research Site
Portland, Oregon, 97239

AstraZeneca
Parexel
NCT Number
Keywords
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.
MeSH Terms
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Olaparib
Intervention Name
Olaparib tablets