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
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
bioavailability (anhydrate capsules) food (monohydrae capsules)
City of Hope National Medical Center
Duarte, California, United States
University of California at Los Angeles
Los Angeles, California, United States
Duke University Medical Center Cancer Dept
Durham, North Carolina, 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 capsules) as compared to the clinical service form of TKI258 (anhydrate capsules)
Time frame: 9 days
Determine the effect of food on the bioavailability of TKI258
Time frame: 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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