Study of Axitinib in Patients With Unresectable Hepatocellular Carcinoma

A Phase II Trial of Axitinib (AG-013736) After Prior Antiangiogenic Therapy in Advanced Hepatocellular Carcinoma

The purpose of this study is to evaluate the potential role of Axitinib (AG-013736) in the treatment of unresectable/metastatic hepatocellular carcinoma (HCC)

This is a phase II study of an investigational drug, Axitinib following prior antiangiogenic therapy in patients with advanced hepatocellular carcinoma. Hepatocellular carcinoma (HCC) is a primary cancer of the liver. Angiogenesis is a physiological process involving the growth of new blood vessels from pre-existing vessels. A tyrosine kinase is an enzyme that can inhibit angiogenesis. In this study, patients with advanced HCC who have failed prior antiangiogenic therapy, will receive Axitinib in cycles of 4 weeks. Axitinib is an oral, potent and selective inhibitor of angiogenesis. This study will evaluate the response rate of HCC following treatment with Axitinib as well as safety, feasibility, overall survival of patients, progression-free survival, and quality of life in persons with unresectable HCC. The study also compares response determined by RECIST to response determined by Choi Criteria.

Inclusion Criteria:

• Unresectable and/or metastatic Hepatocellular Carcinoma
• Previous treatment with tyrosine kinase inhibitors or antiangiogenic drugs
• Life expectancy of ≥12 weeks
• At least one tumor lesion
• At least 2 weeks since the end of prior systemic treatment
• No evidence of pre-existing uncontrolled hypertension
• ECOG 0 or 1
• Adequate organ function
• Not appropriate for curative therapy
• Child A or B7 cirrhosis
• CLIP score ≤ 4

Exclusion Criteria:

• Received any other systemic therapy for Hepatocellular Carcinoma within 2 weeks prior to treatment
• Major surgery <4 weeks or radiation therapy <2 weeks of starting the study treatment
• Previous or concurrent cancer that is distinct in primary site or histology from Hepatocellular Carcinoma
• Severe acute or chronic medical or psychiatric condition
• Need for treatment with prohibited drugs
• Has received local therapy to all measurable lesions
• Stage B8 or higher liver cirrhosis
• Ascites refractory to diuretic therapy
• Clinically significant ECG abnormality