This trial is active, not recruiting.

Condition hepatocellular carcinoma
Treatment axitinib (ag-013736)
Phase phase 2
Sponsor University Health Network, Toronto
Collaborator Pfizer
Start date January 2011
End date December 2016
Trial size 29 participants
Trial identifier NCT01334112, WS515376


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Oral Axitinib (5mg, twice daily) will be administered to all patients
axitinib (ag-013736)
5mg, oral, twice daily, continuous dosing. A dosing cycle is defined as 4 weeks. Treatment may continue until disease progression/relapse

Primary Outcomes

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

Secondary Outcomes

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
time frame: At completion of trial, 1.5 years
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: At completion of trial, 1.5 years
Number of Participants with Adverse Events as a Measure of Safety
time frame: At completion of trial, 1.5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase II Trial of Axitinib (AG-013736) After Prior Antiangiogenic Therapy in Advanced Hepatocellular Carcinoma
Principal investigator Jennifer Knox, MSc, FRCPC, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.