Study of ARQ 197 in Hepatocellular Carcinoma (HCC)
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 Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of ARQ 197 in Advanced Hepatocellular Carcinoma|
- Number of participants with dose-limiting toxicity (DLT), as a measure of safety and tolerability [ Time Frame: DLT observation period will be the first 28 days after the start of ARQ 197 treatment. ] [ Designated as safety issue: Yes ]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.
- Profiles of Pharmacokinetics [ 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. ] [ Designated as safety issue: No ]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).
- Antitumor effects according to RECIST 1.1. [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
|Experimental: ARQ 197||
Drug: ARQ 197
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.
Other Name: Tivantinib