Abstract

Methods: The objectives of this trial are to evaluate the safety and pharmacokinetic (PK) behavior of CF102 in HCC patients. Utilizing a “3+3” design, successive cohorts of patients with advanced HCC were enrolled at CF 102 doses of 1, 5, or 25 mg twice daily, given orally in continuous cycles of 28 days each. Progression to a higher-dose cohort was based on first cycle toxicity. Standard safety and PK assessments were performed; αfetoprotein (AFP) levels were obtained each cycle, and tumor imaging was obtained every other cycle.

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