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

Summary

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.

Timeline

Start

2010-01

Primary completion

2012-07

Completion

2012-07

Outcome

Missed primary endpoint

Stopped: “See termination reason in detailed description”

paper Predefined superiority and noninferiority OS boundaries were not met for linifanib and the study failed to meet the primary end point. PMID 25488963 ↗

Publications

• Kolamunnage-Dona R, Berhane S, Potts H, Williams EH, Tanner J, Janowitz T, Hoare M, Johnson P. Sorafenib is associated with a reduced rate of tumour growth and liver function deterioration in HCV-induced hepatocellular carcinoma. J Hepatol. 2021 Oct;75(4):879-887. doi: 10.1016/j.jhep.2021.05.015. Epub 2021 May 27.
• Cainap C, Qin S, Huang WT, Chung IJ, Pan H, Cheng Y, Kudo M, Kang YK, Chen PJ, Toh HC, Gorbunova V, Eskens FA, Qian J, McKee MD, Ricker JL, Carlson DM, El-Nowiem S. Linifanib versus Sorafenib in patients with advanced hepatocellular carcinoma: results of a randomized phase III trial. J Clin Oncol. 2015 Jan 10;33(2):172-9. doi: 10.1200/JCO.2013.54.3298. Epub 2014 Dec 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ABT-869	Unknown	17.5 mg	Oral
Comparator	Sorafenib	Small molecule	400 mg	Oral

Indications