Study of ARQ 197 in Hepatocellular Carcinoma (HCC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT01656265
First received: July 20, 2012
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Advanced Hepatocellular Carcinoma
Drug: ARQ 197
Phase 1

Study Type: Interventional
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

Further study details as provided by Kyowa Hakko Kirin Company, Limited:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: July 2012
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656265

Locations
Japan
Kashiwa-city, Chiba, Japan
Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
  More Information

No publications provided

Responsible Party: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT01656265     History of Changes
Other Study ID Numbers: ARQ 197-008
Study First Received: July 20, 2012
Last Updated: April 14, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on July 23, 2014