28
Participants
Start Date
June 30, 2011
Primary Completion Date
October 31, 2015
Study Completion Date
October 31, 2015
TH-302 preoperative
TH-302 single dose at 575 mg/m2 administered preoperatively, followed by postoperative combination therapy bevacizumab at 10mg/kg every 2 weeks and TH-302 at 240 - 480 mg/m2 every 2 weeks (4 week cycle) until disease progression. Subjects will be randomized (2:1) to receive pre-operative dose of TH-302.
Placebo
Placebo administered preoperatively, followed by postoperative combination therapy bevacizumab at 10mg/kg every 2 weeks and TH-302 at 240 - 480 mg/m2 every 2 weeks (4 week cycle) until disease progression. Subjects will be randomized (2:1) to receive pre-operative dose of TH-302.
TH-302 (escalating) with bevacizumab 10mg/kg
Combination of 10mg/m2 of bevacizumab with an escalating dose of TH-302 from 240 to 670 mg/m2
Cancer Therapy & Research Center at UTHSCSA, San Antonio
The University of Texas Health Science Center at San Antonio
OTHER