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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

July 20, 2012
April 14, 2014
July 2012
March 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01656265 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of ARQ 197 in Hepatocellular Carcinoma (HCC)
Phase I Study of ARQ 197 in Advanced Hepatocellular Carcinoma

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Hepatocellular Carcinoma
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
Experimental: ARQ 197
Intervention: Drug: ARQ 197
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
24
Not Provided
March 2014   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01656265
ARQ 197-008
No
Kyowa Hakko Kirin Company, Limited
Kyowa Hakko Kirin Company, Limited
Not Provided
Not Provided
Kyowa Hakko Kirin Company, Limited
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP