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

Stopped early · Phase 3

Conditions studied: Hepatocellular Carcinoma Non-resectable, Hepatocellular Carcinoma Recurrent, Carcinoma, Hepatocellular, Liver Diseases, Neoplasms by Histologic Type, Digestive System Neoplasms, Carcinoma, Liver Neoplasms, Neoplasms, Neoplasms by Site, Digestive System Diseases, Adenocarcinoma, Neoplasms, Glandular and Epithelial

In brief

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.

Key facts

Study ID

NCT01009593

Run by

Abbott

People needed

1035

Starts

2010-01-01

Expected to finish

2012-07-01

Last updated by the study team

2012-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Site Reference ID/Investigator# 23608 — LaVerne, California, United States
• Site Reference ID/Investigator# 23852 — Orange, California, United States
• Site Reference ID/Investigator# 40162 — Orange, California, United States
• Site Reference ID/Investigator# 23254 — Newark, Delaware, United States
• Site Reference ID/Investigator# 23253 — Gainesville, Georgia, United States
• Site Reference ID/Investigator# 23609 — Honolulu, Hawaii, United States
• Site Reference ID/Investigator# 24848 — Honolulu, Hawaii, United States
• Site Reference ID/Investigator# 23250 — Louisville, Kentucky, United States
• Site Reference ID/Investigator# 23257 — St Louis, Missouri, United States
• Site Reference ID/Investigator# 23603 — Las Vegas, Nevada, United States
• Site Reference ID/Investigator# 23244 — Durham, North Carolina, United States
• Site Reference ID/Investigator# 23252 — Portland, Oregon, United States
• Site Reference ID/Investigator# 35705 — Buenos Aires, Argentina
• Site Reference ID/Investigator# 35702 — Rosario, Santa Fe, Argentina
• Site Reference ID/Investigator# 23152 — Camperdown, Australia
• Site Reference ID/Investigator# 23150 — Concord, Australia
• Site Reference ID/Investigator# 27122 — Kingswood, Australia
• Site Reference ID/Investigator# 23153 — Kogarah, Australia
• Site Reference ID/Investigator# 24103 — Southport, Australia
• Site Reference ID/Investigator# 27968 — Graz, Austria
• Site Reference ID/Investigator# 27969 — Innsbruck, Austria
• Site Reference ID/Investigator# 27970 — Linz, Austria
• Site Reference ID/Investigator# 27967 — Vienna, Austria
• Site Reference ID/Investigator# 38902 — Brussels, Belgium
• Site Reference ID/Investigator# 23247 — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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