Efficacy and Tolerability of ABT-869 Versus Sorafenib in Advanced Hepatocellular Carcinoma (HCC)

Abbott

Status and phase

Terminated

Phase 3

Conditions

Hepatocellular Carcinoma Recurrent

Hepatocellular Carcinoma Non-resectable

Carcinoma, Hepatocellular

Neoplasms by Site

Neoplasms, Glandular and Epithelial

Digestive System Diseases

Carcinoma

Digestive System Neoplasms

Adenocarcinoma

Neoplasms by Histologic Type

Neoplasms

Liver Neoplasms

Liver Diseases

Treatments

Drug: ABT-869

Drug: Sorafenib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01009593

M10-963

2009-013435-38 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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

Enrollment

1,035 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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

Exclusion Criteria

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