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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 InstituteTampa, Florida  33612
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Alta Bates Summit Comprehensive Cancer CenterBerkeley, California  94704
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
University of California Irvine Medical CenterOrange, California  92668
UCSD Medical Center- La JollaLa Jolla, California  92037
Ship Drugs to:Orange, California  92868
UCSD Medical Center- HillcrestSan Diego, California  92103
Penn Presbyterian Medical CenterPhiladelphia, Pennsylvania  19104-2699
Florida Hospital OrlandoOrlando, Florida  32804
A. Alfred Taubman Health Care CenterAnn Arbor, Michigan  48109