Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma Hepatoma HCC
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 19
Healthy volunteers: no

Brief summary:
This trial will test the safety and efficacy of CF102 in patients with advanced liver cancer. Successive groups of patients will be given higher doses of CF102 by mouth on a twice-daily basis. Treatment will be assessed for adverse effects and for effects on the tumor.

Detailed description:
This is a multicenter, open-label, non-randomized, dose-escalation study, to be conducted in 2 phases: a dose-escalation phase, to determine the MTD of CF102 and to evaluate its safety/tolerability, PK, pharmacodynamic, and preliminary clinical activity; and a dose-confirmation phase, which will be a cohort expansion at or below the MTD (ie, the RP2D) of CF102. Subjects will be treated with oral doses of CF102 in consecutive, 28-day cycles. The initial dose of CF102 will be 1 mg twice daily (BID), with subsequent escalations to 5 and 25 mg BID, unless limited by toxicity. Subjects will be evaluated weekly for the first cycle, every 2 weeks for Cycles 2 and 3, and at the end of each subsequent cycle, up to 6 cycles of CF102 treatment. Subjects will return for a follow-up visit 28 days after completion of the last dose of study drug.

Arms:
arm 1: An open-label trial in 28-day cycles. arm 2: An open-label trial in 28-day cycles. arm 3: An open-label trial in 28-day cycles.

Interventions: intervention 1: CF102
Intervention descriptions: intervention 1: CF102 capsules twice daily by mouth

Protocol document: