Expanded Access Program for Olaparib Tablets as Maintenance Therapy in Patients With Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
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|ClinicalTrials.gov Identifier: NCT03079687|
Expanded Access Status : Approved for marketing
First Posted : March 14, 2017
Last Update Posted : October 25, 2017
Information provided by (Responsible Party):
|First Submitted Date||March 8, 2017|
|First Posted Date||March 14, 2017|
|Last Update Posted Date||October 25, 2017|
|Brief Title||Expanded Access Program for Olaparib Tablets as Maintenance Therapy in Patients With 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.|
|Study Type||Expanded Access|
|Expanded Access Type||Treatment IND/Protocol|
|Intervention||Drug: Olaparib tablets
Patients will receive olaparib tablets 300mg (two 150mg tablets) twice daily.
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Expanded Access Status||Approved for marketing|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Verification Date||October 2017|