13
Participants
Start Date
June 30, 2009
Primary Completion Date
August 31, 2010
Study Completion Date
August 31, 2010
KW-2450
Dose escalation may proceed once \>= 3 subjects have completed the Day 29 blood sample to evaluate glucose. The safety of each dose level will be established prior to enrollment of subjects in the next dose level. Dose escalation will proceed sequentially with accelerated escalation. Once the criteria for completing the accelerated titration are reached, dose escalation will follow a modified Fibonacci schedule. Up to 6 subjects will be enrolled at each dose level. Enrollment will proceed until the maximum tolerated dose (MTD) has been established or the highest dose level (800 mg/day) has been reached. The Sponsor will enroll up to 12 additional subjects, in an expanded safety cohort.
Memorial Sloan Kettering, New York
Karmanos Cancer Institute, Detroit
University of Maryland Greenbaum Cancer Center, Baltimore
Collaborators (1)
Kyowa Hakko Kirin Pharma, Inc.
INDUSTRY
Kyowa Kirin Co., Ltd.
INDUSTRY