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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01334112
First received: February 14, 2011
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Hepatocellular Carcinoma
Drug: Axitinib (AG-013736)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Axitinib (AG-013736) After Prior Antiangiogenic Therapy in Advanced Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Response rate [ Time Frame: Response rate assessed by CT scan at 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Feasibility [ Time Frame: Assessed at the end of stage 1 (10 patients accrued) and at the end of trial (Stage 2, 29 patients total) ] [ Designated as safety issue: Yes ]
    The ability to administer one or more cycles of Axitinib to >70% of patients at a dose of 5mg po BID

  • Overall survival [ Time Frame: At the completion of trial, 1.5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: At trial completion, 1.5 years ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: At completion of trial, 1.5 years ] [ Designated as safety issue: No ]
    Assessed by FACT-Hep

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: At completion of trial, 1.5 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: At completion of trial, 1.5 years ] [ Designated as safety issue: Yes ]
    Adverse effects profile and rate of grade 3 and 4 toxicity will be assessed as a measure of safety


Estimated Enrollment: 29
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334112

Locations
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
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
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01334112     History of Changes
Other Study ID Numbers: WS515376
Study First Received: February 14, 2011
Last Updated: August 28, 2014
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Hepatocellular Carcinoma
Advanced Hepatocellular Carcinoma
Liver Cancer
Axitinib
AG-013736

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

ClinicalTrials.gov processed this record on October 23, 2014