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Trial record 1 of 1 for:    NCT03079687
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Expanded Access Program for Olaparib Tablets as Maintenance Therapy in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer.

This treatment has been approved for sale to the public.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03079687
First Posted: March 14, 2017
Last Update Posted: October 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Parexel
Information provided by (Responsible Party):
AstraZeneca
March 8, 2017
March 14, 2017
October 25, 2017
 
Expanded Access Program for Olaparib Tablets as Maintenance Therapy in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
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.
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.
Expanded Access
, Treatment IND/Protocol
Drug: Olaparib tablets
Patients will receive olaparib tablets 300mg (two 150mg tablets) twice daily.
Not Provided
 
Approved for marketing
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT03079687
AstraZeneca
AstraZeneca
Parexel
Not Provided
AstraZeneca
October 2017