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.

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