33
Participants
Start Date
September 30, 2010
Primary Completion Date
September 30, 2012
Study Completion Date
December 31, 2012
Tesetaxel
"Tesetaxel capsules orally once every 21 days; duration of therapy not to exceed 12 months~In Cycle 1, a dose of 27 mg/m2 will be administered. In subsequent cycles,~* the dose will be increased to 35 mg/m2 in Cycle 2 for subjects who did not have an ANC \< 1,500/mm3, a platelet count \< 100,000/mm3, or a Grade 3 (or higher grade) nonhematologic adverse event considered by the Investigator to be related to protocol therapy (excluding alopecia, nausea, and vomiting) in Cycle 1. The dose is not to exceed the dose of 35 mg/m2 in any cycle subsequent to Cycle 2.~* for all other subjects, the dose administered in Cycle 1 (27 mg/m2) will be administered in all subsequent cycles."
RECRUITING
Memorial Sloan-Kettering Cancer Center, New York
RECRUITING
Thomas Jefferson University Hospital, Philadelphia
RECRUITING
San Camillo Forlanini Hospital, Rome
Lead Sponsor
Genta Incorporated
INDUSTRY