This study will evaluate the relative bioavailability of 2 oral formulations of TKI258, and the effect of food on the bioavailability of TKI258, in adult patients with advanced solid tumor.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Scottsdale Healthcare/TGen Clinical Research Service TGen Clinical Research Service
Scottsdale, Arizona, United States
Duke University Medical Center
Durham, North Carolina, United States
Sarah Cannon Research Institute Sarah Cannon Research Instit
Nashville, Tennessee, United States
University of Utah / Huntsman Cancer Institute
Salt Lake City, Utah, United States
Determine the relative bioavailability of the final market image form of TKI258 (monohydrate tablets) as compared to the clinical service form of TKI258 (anhydrate capsules)
Time frame: relative bioavailability (9 days)
Determine the effect of food on the bioavailability of TKI258
Time frame: food effect (22 days)
Characterize the safety and tolerability of TKI258, including acute and chronic toxicities.
Time frame: Up to 28 days after the last dose of study drug
Evaluate preliminary evidence of anti-tumor activity of TKI258 in patients with advanced solid tumors.
Time frame: Every 8 weeks until progression of disease
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