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Number: GOG 0076HH Principal Investigator: Mutch, David
Title: A Limited Access Phase I/II Trial of Paclitaxel, Cisplatin and CTEP Supplied Agent ABT-888 (Velaparib) (IND #77840) in the Treatment of Advanced, Persistent, or Recurrent Carcinomas of Cervix
Phase: I/II Disease Site: Cervix Uteri
Participating Site(s):
 
 
Contact: 800-600-3606 or info@ccadmin.wustl.edu

Description:
The purpose of the first part of this study (called Phase I) is to test how safe ABT-888 is and to determine the appropriate dose of ABT-888 to be used in the Phase II part of the study. If you enter the study on the Phase I portion, the dose of ABT-888 you will receive will depend on when you enter the study as doses increase for each group of subjects in this part of the study. ABT-888 is given in a capsule form and is also known as Velaparib. ABT-888 will be given in combination with the drugs cisplatin and paclitaxel which are given intravenously (though a vein). The purpose of the second part of this study (Phase II) is to determine the effectiveness of ABT-888 (given at the dose determined during the Phase I portion) in combination with intravenous (through the vein, IV) cisplatin and paclitaxel. We will also be looking at the types and severity of side effects caused by treatment with this drug. ABT-888 is an experimental drug known as a PARP Inhibitor that kills cancer cells by preventing the repair of DNA or genetic damage. Cisplatin and Paclitaxel are approved for cervical cancer treatment.
 
More Information:
Internal Protocol Documents (requires Siteman administrative database password)