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A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Hepato Cellular Carcinoma (HCC)

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Trial Information

A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma


Inclusion Criteria:



- Histologic or cytologic confirmed diagnosis of HCC.

- Advanced HCC: disease not eligible for surgical and/or locoregional therapies OR
progressive disease after surgical and/or locoregional therapies

- Child-Pugh Class A

- ECOG performance status 0-1

- Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

- Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular
targeted agents for HCC

- History of active cardiac disease

- Thrombotic or embolic events within the past 6 months (except HCC tumor thrombus)

- Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 8 weeks except for
esophageal or gastric varices

- Inability to swallow tablets or untreated malabsorption syndrome

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment

Outcome Time Frame:

Survival will be assessed continuously

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Study ID:

CA182-033

NCT ID:

NCT00858871

Start Date:

May 2009

Completion Date:

December 2012

Related Keywords:

  • Hepato Cellular Carcinoma (HCC)
  • Carcinoma
  • Carcinoma, Hepatocellular

Name

Location

James Graham Brown Cancer CenterLouisville, Kentucky  40202
3912 Taubman CenterAnn Arbor, Michigan  48109-0362
McGuire DVAMCRichmond, Virginia  23249
Sharp Clinical Oncology ResearchSan Diego, California  92123
Karmanos Cancer InstituteDetroit, Michigan  48201
University of WisconsinMadison,, Wisconsin  53792-5666
Mayo Clinic ArizonaScottsdale, Arizona  85259
Medical Specialists Of Palm BeachesLake Worth, Florida  33467
Univ Of Ark For Med SciLittle Rock, Arkansas  72205
Agajanian Institute Of Hematology And OncologyDowney, California  90241
Va Ct Healthcare SystemWest Haven, Connecticut  06516
Pennsylvania Oncology/Hematology AssociatesPhiladelphia, Pennsylvania  19106
Thomas Jefferson Univ.Philadelphia, Pennsylvania  19107