Study of ARQ 197 in Hepatocellular Carcinoma (HCC)

Kyowa Kirin

Status and phase: Completed; Phase 1

Conditions: Advanced Hepatocellular Carcinoma

Treatments: Drug: ARQ 197

Study type: Interventional

Funder types: Industry

Identifiers

NCT01656265

ARQ 197-008

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

ARQ 197

Experimental group

Treatment:

Drug: ARQ 197