An Open-label, Randomized Phase 3 Study of the Efficacy and Tolerability of Linifanib (ABT-869) Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma (HCC)

TerminadoFase 3ClinicalTrials.gov

ID: NCT01009593Tipo: INTERVENTIONALInicio: 1 de ene de 2010Fin estimado: 1 de jul de 2012

Traducción no disponible, mostrando original

Resumen

The primary objective of this study is to assess the overall survival (OS) of oral linifanib given as monotherapy once daily (QD) compared to sorafenib given twice daily (BID) per standard of care in subjects with advanced or metastatic HCC.

Descripción detallada

The IDMC recommended discontinuation of the study, and, the protocol was amended to end study treatment.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologic or cytologic diagnosis with unresectable or metastatic HCC
Child Pugh Class A
ECOG performance status 0-1
Adequate hematologic, hepatic, and renal function

Criterios de exclusión

Prior systemic (administered intravenously or orally rather than locoregionally) treatment for HCC
Prior local therapy (including liver-directed therapy) within 4 weeks from entry
Untreated brain or meningeal metastases
Current treatment on another clinical trial
Pregnancy or breastfeeding

Intervenciones

drug

ABT-869

Tablets, Oral, 17.5 mg, Once Daily, Until disease progression or unacceptable toxicity

drug

Sorafenib

Tablets, Oral, 400 mg, Twice Daily, Until disease progression or unacceptable toxicity.

Ubicaciones

Site Reference ID/Investigator# 35705

Buenos Aires, Argentina

Site Reference ID/Investigator# 35702

Rosario, Santa Fe, Argentina

Patrocinadores

PrincipalAbbott

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