Study of Axitinib in Patients With Unresectable Hepatocellular Carcinoma (AXITINIB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01334112
Recruitment Status : Completed
First Posted : April 12, 2011
Last Update Posted : August 14, 2018
Information provided by (Responsible Party):
University Health Network, Toronto

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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 : January 2011
Actual Primary Completion Date : March 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Axitinib

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

Primary Outcome Measures :
  1. Response rate [ Time Frame: Response rate assessed by CT scan at 16 weeks ]

Secondary Outcome Measures :
  1. Feasibility [ Time Frame: 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

  2. Overall survival [ Time Frame: At the completion of trial, 1.5 years ]
  3. 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 ]
  4. Progression-free survival [ Time Frame: At trial completion, 1.5 years ]
  5. Quality of life [ Time Frame: At completion of trial, 1.5 years ]
    Assessed by FACT-Hep

  6. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 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

  7. Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01334112

Canada, Alberta
Foothills Hospital, Alberta Health Services
Calgary, Alberta, Canada
Canada, Ontario
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Jennifer Knox, MSc, FRCPC, MD University Health Network, Princess Margaret Hospital
Principal Investigator: Kelly Burak, MD, FRCPC, BSc, MSc University of Calgary

Responsible Party: University Health Network, Toronto Identifier: NCT01334112     History of Changes
Other Study ID Numbers: WS515376
First Posted: April 12, 2011    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

Keywords provided by University Health Network, Toronto:
Hepatocellular Carcinoma
Advanced Hepatocellular Carcinoma
Liver Cancer

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action