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Completed

NCT Number: NCT01656265

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.

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Key information

Conditions

Advanced Hepatocellular Carcinoma

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kashiwa, Chiba, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARQ 197

Drug

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 names: Tivantinib

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Kyowa Kirin Co., Ltd.

Industry

Registry information

Official study title

Phase I Study of ARQ 197 in Advanced Hepatocellular Carcinoma

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 2, 2012
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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