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

Phase 2
18 Years
Open (Enrolling)
Hepatocellular Carcinoma

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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

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:


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:


Principal Investigator

Jennifer Knox, MSc, FRCPC, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Princess Margaret Hospital


Canada: Health Canada

Study ID:




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