This is a phase l study to examine Absorption, Distribution, Metabolism and Excretion of TKI258. There are 2 cohorts. Cohort 1 (4 patients) will receive single radio-labeled 500mg dose of TKI258 followed after 15 days by daily dosing of 400mg TKI258. Cohort 2 (9 patients) will receive 400mg TKI258.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Novartis Investigative Site
Amsterdam, Netherlands
Cohort1: Find out about the routes and rates of excretion of TKI258 and its metabolites
Time frame: Day 15
Cohort 2: Safety and Tolerability of TKI258
Time frame: Time to patient withdrawal due to disease progression or tolerability issues
Cohort 1: Safety and tolerability of TKI258
Time frame: Time to patient withdrawal due to disease progression or tolerability issues
Cohort 1: Preliminary anti-tumor activity of TKI258
Time frame: Time to tumor progression
Preliminary Anti-tumor activity of TKI258
Time frame: Time to tumor progression
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