27
Participants
Start Date
February 28, 2010
Primary Completion Date
March 31, 2012
Study Completion Date
March 31, 2012
Tesetaxel
"Tesetaxel capsules will be administered orally once every 21 days until the patient meets a withdrawal criterion or initiates nonstudy therapy for melanoma. The duration of protocol therapy will not exceed 12 months.~In Cycle 1, a flat dose of 40 mg will be administered to patients of relatively normal weight. For patients who weigh at least 25% below their ideal body weight, a flat dose of 35 mg will be administered. For patients who weigh at least 25% above their ideal body weight, a flat dose of 45 mg will be administered. Dose escalation by 5 mg in Cycle 2 and an additional 5 mg in Cycle 3 is permitted provided protocol-specified criteria are met."
RECRUITING
The University of Texas MD Anderson Cancer Center, Houston
Lead Sponsor
Genta Incorporated
INDUSTRY