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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Axitinib (AG-013736)
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma, Liver Cancer, Axitinib, AG-013736

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Foothills Hospital, Alberta Health Services
  • University Health Network, Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Axitinib

Arm Description

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

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Feasibility
The ability to administer one or more cycles of Axitinib to >70% of patients at a dose of 5mg po BID
Overall survival
Response rate comparison
Progression-free survival
Quality of life
Assessed by FACT-Hep
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
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

Full Information

First Posted
February 14, 2011
Last Updated
December 11, 2019
Sponsor
University Health Network, Toronto
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01334112
Brief Title
Study of Axitinib in Patients With Unresectable Hepatocellular Carcinoma
Acronym
AXITINIB
Official Title
A Phase II Trial of Axitinib (AG-013736) After Prior Antiangiogenic Therapy in Advanced Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular Carcinoma, Advanced Hepatocellular Carcinoma, Liver Cancer, Axitinib, AG-013736

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Axitinib
Arm Type
Experimental
Arm Description
Oral Axitinib (5mg, twice daily) will be administered to all patients
Intervention Type
Drug
Intervention Name(s)
Axitinib (AG-013736)
Intervention Description
5mg, oral, twice daily, continuous dosing. A dosing cycle is defined as 4 weeks. Treatment may continue until disease progression/relapse
Primary Outcome Measure Information:
Title
Response rate
Time Frame
Response rate assessed by CT scan at 16 weeks
Secondary Outcome Measure Information:
Title
Feasibility
Description
The ability to administer one or more cycles of Axitinib to >70% of patients at a dose of 5mg po BID
Time Frame
Assessed at the end of stage 1 (10 patients accrued) and at the end of trial (Stage 2, 29 patients total)
Title
Overall survival
Time Frame
At the completion of trial, 1.5 years
Title
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
Title
Progression-free survival
Time Frame
At trial completion, 1.5 years
Title
Quality of life
Description
Assessed by FACT-Hep
Time Frame
At completion of trial, 1.5 years
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
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
Time Frame
At completion of trial, 1.5 years
Title
Number of Participants with Adverse Events as a Measure of Safety
Description
Adverse effects profile and rate of grade 3 and 4 toxicity will be assessed as a measure of safety
Time Frame
At completion of trial, 1.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Knox, MSc, FRCPC, MD
Organizational Affiliation
University Health Network, Princess Margaret Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kelly Burak, MD, FRCPC, BSc, MSc
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foothills Hospital, Alberta Health Services
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
University Health Network, Princess Margaret Hospital
City
Toronto
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Study of Axitinib in Patients With Unresectable Hepatocellular Carcinoma

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