Status:

COMPLETED

Axitinib For The Treatment Of Advanced Hepatocellular Carcinoma

Lead Sponsor:

Pfizer

Conditions:

Hepatocellular Carcinoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The study is designed to demonstrate that axitinib plus best supportive care is superior to placebo plus best supportive care in prolonging survival in patients with advanced hepatocellular carcinoma.

Eligibility Criteria

Inclusion

  • Locally advanced or metastatic HCC
  • Failure of one prior antiangiogenic therapy including sorafenib, bevacizumab and brivanib.
  • Child-Pugh Class A or B (score 7 only) disease.

Exclusion

  • Prior treatment of advanced HCC with more than one prior first-line systemic therapy.
  • Any prior local therapy within 2 weeks of starting the study treatment.
  • Presence of hepatic encephalopathy and/or clinically relevant ascites.
  • Presence of main portal vein invasion by HCC.

Key Trial Info

Start Date :

December 6 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 20 2016

Estimated Enrollment :

224 Patients enrolled

Trial Details

Trial ID

NCT01210495

Start Date

December 6 2010

End Date

December 20 2016

Last Update

January 9 2019

Active Locations (77)

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Page 1 of 20 (77 locations)

1

Alta Bates Summit Comprehensive Cancer Center

Berkeley, California, United States, 94704

2

UCSD Medical Center- La Jolla

La Jolla, California, United States, 92037

3

Moores UCSD Cancer Center

La Jolla, California, United States, 92093

4

University of California Irvine Medical Center

Orange, California, United States, 92868