A Randomized, Double-blind, Multicenter Phase III Study of Brivanib Versus Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Embolization (TACE) in Patients With Unresectable Hepatocellular Carcinoma (The BRISK TA Study)

CompletadoFase 3ClinicalTrials.gov

ID: NCT00908752Tipo: INTERVENTIONALInicio: 20 de jul de 2009Fin estimado: 26 de ene de 2018

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Patients with diagnosis of hepatocellular carcinoma
Cirrhotic status of Child-Pugh Class A or B with a score of 7
ECOG performance status of 0 or 1
Adequate hematologic, hepatic, and renal function

Criterios de exclusión

Prior use of any systemic anticancer chemotherapy, immunotherapy, investigational or molecular targeted agents for HCC
History of cardiac disease
Active and untreated hepatitis B
Inability to swallow tablets or untreated malabsorption syndrome
History of human immunodeficiency virus (HIV) infection

Intervenciones

drug

Brivanib

Tablets, Oral, 200 mg, once daily, until disease progression or toxicity

other

Brivanib Placebo

Tablets, Oral, 0 mg, once daily, until disease progression or toxicity

procedure

TACE Therapy

Trans-Arterial Chemo-Embolization Therapy

Ubicaciones

Local Institution

Capital Federal, Buenos Aires, Argentina

Local Institution

Buenos Aires, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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