AXITINIB: Study of Axitinib in Patients With Unresectable Hepatocellular Carcinoma

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT01334112

Collaborator

Pfizer (Industry)

Enrollment

Locations

Arm

85.9

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Drug: Axitinib (AG-013736)	Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2011

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

Mar 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Axitinib Oral Axitinib (5mg, twice daily) will be administered to all patients	Drug: Axitinib (AG-013736) 5mg, oral, twice daily, continuous dosing. A dosing cycle is defined as 4 weeks. Treatment may continue until disease progression/relapse

Arm

Intervention/Treatment

Experimental: Axitinib

Oral Axitinib (5mg, twice daily) will be administered to all patients

Drug: Axitinib (AG-013736)

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

Outcome Measures

Primary Outcome Measures

Response rate [Response rate assessed by CT scan at 16 weeks]

Secondary Outcome Measures

Feasibility [Assessed at the end of stage 1 (10 patients accrued) and at the end of trial (Stage 2, 29 patients total)]
The ability to administer one or more cycles of Axitinib to >70% of patients at a dose of 5mg po BID
Overall survival [At the completion of trial, 1.5 years]
Response rate comparison [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 [At trial completion, 1.5 years]
Quality of life [At completion of trial, 1.5 years]
Assessed by FACT-Hep
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [At completion of trial, 1.5 years]
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
Number of Participants with Adverse Events as a Measure of Safety [At completion of trial, 1.5 years]
Adverse effects profile and rate of grade 3 and 4 toxicity will be assessed as a measure of safety

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Foothills Hospital, Alberta Health Services	Calgary	Alberta	Canada
2	University Health Network, Princess Margaret Hospital	Toronto	Ontario	Canada

Sponsors and Collaborators

University Health Network, Toronto
Pfizer

Investigators

Principal Investigator: Jennifer Knox, MSc, FRCPC, MD, University Health Network, Princess Margaret Hospital
Principal Investigator: Kelly Burak, MD, FRCPC, BSc, MSc, University of Calgary