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A Multicenter, Global, Randomized, Double-Blind Study Of Axitinib Plus Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients With Advanced Hepatocellular Carcinoma Following Failure Of One Prior Antiangiogenic Therapy


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

Thank you

Trial Information

A Multicenter, Global, Randomized, Double-Blind Study Of Axitinib Plus Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients With Advanced Hepatocellular Carcinoma Following Failure Of One Prior Antiangiogenic Therapy


Inclusion Criteria:



- 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Overall Survival

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

A4061058

NCT ID:

NCT01210495

Start Date:

December 2010

Completion Date:

January 2014

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada  89109
Methodist Estabrook Cancer Center Omaha, Nebraska  68114-4199
Moores UCSD Cancer Center La Jolla, California  92093-0658
Alta Bates Summit Comprehensive Cancer Center Berkeley, California  94704
Hospital of the University of Pennsylvania Philadelphia, Pennsylvania  19104
University of California Irvine Medical Center Orange, California  92668
UCSD Medical Center- La Jolla La Jolla, California  92037
Ship Drugs to: Orange, California  92868
UCSD Medical Center- Hillcrest San Diego, California  92103
Penn Presbyterian Medical Center Philadelphia, Pennsylvania  19104-2699
Florida Hospital Orlando Orlando, Florida  32804
A. Alfred Taubman Health Care Center Ann Arbor, Michigan  48109