A Phase II Trial of Axitinib (AG-013736) After Prior Antiangiogenic Therapy in Advanced Hepatocellular Carcinoma
18 Years
N/A
Both
Hepatocellular Carcinoma
Trial Information
A Phase II Trial of Axitinib (AG-013736) After Prior Antiangiogenic Therapy in Advanced Hepatocellular Carcinoma
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Time Frame:
Response rate assessed by CT scan at 16 weeks
Safety Issue:
No
Principal Investigator
Jennifer Knox, MSc, FRCPC, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Health Network, Princess Margaret Hospital
Authority:
Canada: Health Canada
Study ID:
WS515376
NCT ID:
NCT01334112
Start Date:
January 2011
Completion Date:
December 2013
Related Keywords:
- Hepatocellular Carcinoma
- Hepatocellular Carcinoma
- Advanced Hepatocellular Carcinoma
- Liver Cancer
- Axitinib
- AG-013736
- Carcinoma
- Carcinoma, Hepatocellular
Name | Location |
|---|
