Study of Axitinib in Patients With Unresectable Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

— AXITINIB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334112
• Other study ID #: WS515376
• Status: Completed
• Phase: Phase 2
• Start date: January 2011
• Est. completion date: March 2018

Study information

• Verified date: December 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

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

Locations

Country	Name	City	State
Canada	Foothills Hospital, Alberta Health Services	Calgary	Alberta
Canada	University Health Network, Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Pfizer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate		Response rate assessed by CT scan at 16 weeks
Secondary	Feasibility	The ability to administer one or more cycles of Axitinib to >70% of patients at a dose of 5mg po BID	Assessed at the end of stage 1 (10 patients accrued) and at the end of trial (Stage 2, 29 patients total)
Secondary	Overall survival		At the completion of trial, 1.5 years
Secondary	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
Secondary	Progression-free survival		At trial completion, 1.5 years
Secondary	Quality of life	Assessed by FACT-Hep	At completion of trial, 1.5 years
Secondary	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	At completion of trial, 1.5 years
Secondary	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	At completion of trial, 1.5 years