24
Participants
Start Date
October 31, 2003
Primary Completion Date
October 31, 2004
Study Completion Date
February 28, 2006
clofarabine (oral formulation)
Cohorts of 3 patients each were to receive oral clofarabine administered daily for 5 days followed by 23 days of rest (1 cycle) and repeated every 28 days depending on toxicity and response. The starting dose of clofarabine was to be 1 mg/m2/day with subsequent dose escalation to occur in increments of 50% for the first 5 dose levels (1.5, 2.25, 3.5, and 5.0 mg/m2/day) and in increments of 25% thereafter until the MTD/RP2D was determined.
Mary Crowley Medical Research Center, Dallas
Tyler Cancer Institute, Tyler
Cancer Care Northwest, Spokane
Genzyme, a Sanofi Company
INDUSTRY