Study of ARQ 197 in Hepatocellular Carcinoma (HCC)
|ClinicalTrials.gov Identifier: NCT01656265|
Recruitment Status : Completed
First Posted : August 2, 2012
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Advanced Hepatocellular Carcinoma||Drug: ARQ 197||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of ARQ 197 in Advanced Hepatocellular Carcinoma|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
|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
- 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. ]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. ]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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656265
|Kashiwa-city, Chiba, Japan|