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

Ovarian Cancer Clinical Trial

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.

Clinical Trial Details — Status: Approved for marketing

Administrative data

• NCT number: NCT03079687
• Other study ID #: D0816R00014
• Status: Approved for marketing
• Phase: N/A
• First received: March 8, 2017
• Last updated: October 23, 2017

Study information

• Verified date: October 2017
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Approved for marketing
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	Parexel

Country where clinical trial is conducted

United States,