Study of Axitinib in Patients With Unresectable Hepatocellular Carcinoma

University Health Network, Toronto30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

Axitinib (AG-013736)DRUG

5mg, oral, twice daily, continuous dosing. A dosing cycle is defined as 4 weeks. Treatment may continue until disease progression/relapse

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Foothills Hospital, Alberta Health Services

Calgary, Alberta, Canada

University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Response rate

Time frame: Response rate assessed by CT scan at 16 weeks

Secondary Outcomes

Feasibility

The ability to administer one or more cycles of Axitinib to \>70% of patients at a dose of 5mg po BID

Time frame: Assessed at the end of stage 1 (10 patients accrued) and at the end of trial (Stage 2, 29 patients total)

Overall survival

Time frame: At the completion of trial, 1.5 years

Response rate comparison

Time frame: Comparison of outcomes with RECIST criteria to Choi criteria and changes to perfusion on DCE ultrasound will occur at the end of stage 1 (after accrual of 10 patients) and trial completion

Progression-free survival

Time frame: At trial completion, 1.5 years

Quality of life

Assessed by FACT-Hep

Time frame: At completion of trial, 1.5 years

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Efficacy and Toxicity in Asian vs non-Asian patients will be assessed by comparing the adverse effects profile and rate of grade 3 and grade 4 toxicity in these populations

Time frame: At completion of trial, 1.5 years

Number of Participants with Adverse Events as a Measure of Safety

Adverse effects profile and rate of grade 3 and 4 toxicity will be assessed as a measure of safety

Time frame: At completion of trial, 1.5 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.