27
Participants
Start Date
March 31, 2010
Primary Completion Date
September 30, 2012
Study Completion Date
October 31, 2012
Tesetaxel
"For subjects in Cohort A, a flat dose of 40 mg will be administered in Cycle 1; the dose will be adjusted based on body weight. In subsequent cycles, depending on tolerability, the Cycle 1 flat dose may be increased by 5 mg in Cycle 2, and the Cycle 2 flat dose may again be increased by 5 mg in Cycle 3.~For subjects in Cohort B, a flat dose of 50 mg will be administered in Cycle 1; the dose will be adjusted based on body weight. In subsequent cycles, depending on tolerability, the dose may be increased by 10 mg in Cycle 2.~For subjects in Cohort C, a dose of 27 mg/m2 will be administered in Cycle 1. In subsequent cycles, depending on tolerability, the dose will be increased to 35 mg/m2 in Cycle 2."
Abramson Cancer of the University of Pennsylvania at Perelman Center for Advanced Medicine, Philadelphia
Northwestern Medical Faculty Foundation, Chicago
The University of Texax MD Anderson Cancer Center, Houston
Severance Hospital, Yonsei University Health System, Seoul
Lead Sponsor
Genta Incorporated
INDUSTRY