Study of Axitinib in Patients With Unresectable Hepatocellular Carcinoma

• Status: Completed
• Trial end date: 2018-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Pfizer
• Treatments: Axitinib

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