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

CompletadoFase 3ClinicalTrials.gov

ID: NCT00858871Tipo: INTERVENTIONALInicio: 1 de may de 2009Fin estimado: 1 de sept de 2013

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
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

Criterios de exclusión

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

Intervenciones

drug

Brivanib

Tablets, Oral, 800 mg, Once Daily, Until disease progression or unacceptable toxicity

drug

Placebo

Capsules, Oral, twice Daily, Until disease progression or unacceptable toxicity

drug

Sorafenib

Capsules, Oral, 800 mg, twice daily, Until disease progression or unacceptable toxicity

drug

Placebo

Tablets, Oral, Once Daily, Until disease progression or unacceptable toxicity

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Caba, Buenos Aires, Argentina

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Rosario, Santa Fe Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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