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Phase I Study of ARQ 197 in Advanced Hepatocellular Carcinoma

Phase 1
20 Years
Open (Enrolling)
Advanced Hepatocellular Carcinoma

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Trial Information

Phase I Study of ARQ 197 in Advanced Hepatocellular Carcinoma

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

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with dose-limiting toxicity (DLT), as a measure of safety and tolerability

Outcome Description:

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.

Outcome Time Frame:

DLT observation period will be the first 28 days after the start of ARQ 197 treatment.

Safety Issue:



Japan: Ministry of Health, Labor and Welfare

Study ID:

ARQ 197-008



Start Date:

July 2012

Completion Date:

Related Keywords:

  • Advanced Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular