Study of ARQ 197 in Hepatocellular Carcinoma (HCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01656265
Recruitment Status : Completed
First Posted : August 2, 2012
Last Update Posted : March 3, 2017
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd

Brief Summary:
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.

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)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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).

  2. Antitumor effects according to RECIST 1.1. [ Time Frame: Every 6 weeks ]

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Confirmed HCC patients who are resistant to, intolerable to, or rejecting a systemic sorafenib therapy
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Child-Pugh classification A at the time of registration
  • Adequate bone marrow, liver, and renal functions within 14 days prior to registration

Exclusion Criteria:

  • Prior therapy with a c-Met inhibitor (including ARQ 197)
  • Any systemic anti-tumor treatment or investigational agent within 2 weeks prior to registration. If the treatment/agent was antibody, within 4 weeks
  • Local treatment for malignancy within 4 weeks prior to registration
  • Major surgical procedure within 4 weeks prior to registration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01656265

Kashiwa-city, Chiba, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Co., Ltd

Responsible Party: Kyowa Hakko Kirin Co., Ltd Identifier: NCT01656265     History of Changes
Other Study ID Numbers: ARQ 197-008
First Posted: August 2, 2012    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases