The purpose of this study is to evaluate the safety and tolerability of ARQ 197 in hepatocellular carcinoma (HCC) patients treated with daily oral ARQ 197, to determine the recommended dose of ARQ 197 in advanced HCC patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Daily repeating dose of oral ARQ 197, twice a day just after meals. Dose of ARQ 197 will be escalated according to 3+3 rule.
Unnamed facility
Kashiwa, Chiba, Japan
Number of participants with dose-limiting toxicity (DLT), as a measure of safety and tolerability
Adverse Event collection and assessment will be done for all treated subjects to assess the safety, tolerability. The grading for the severity of the adverse events will be determined according to CTCAE ver 4.0.
Time frame: DLT observation period will be the first 28 days after the start of ARQ 197 treatment.
Profiles of Pharmacokinetics
maximum concentration (Cmax), area under the curve (AUC), half-life (t1/2), apparent clearance (Cl/F), and apparent volume of distribution in the terminal elimination phase (Vz/F).
Time frame: Plasma sample correction at pre-dose 1, 2, 4, 6, 10, 12 and 24 hours on day 1; at pre-dose, 1, 2, 4, 6, 10, 12 hours on day 15; and at pre-dose on day 29.
Antitumor effects according to RECIST 1.1.
Time frame: Every 6 weeks
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