Dose Escalation of Sorafenib in Patients With Advanced Hepatocellular Carcinoma (HCC)

Summary

The aim of the study is to evaluate, after radiological progression, efficacy in patients treated with Sorafenib at a dose of 600 mg bid compared to that in patients treated with best supportive care. Primary efficacy objective is progression free survival from randomization.

Timeline

Start

2007-04

Primary completion

2008-06

Completion

—

Outcome

Missed primary endpoint

paper The study did not meet its primary end point. PMID 23580239 ↗

paper The difference in PFS between the sorafenib arm (3.91 months) and the best supportive care arm (2.69 months) did not reach statistical significance (p = 0.086). PMID 23580239 ↗

Publications

• Background Abou-Alfa GK, Schwartz L, Ricci S, Amadori D, Santoro A, Figer A, De Greve J, Douillard JY, Lathia C, Schwartz B, Taylor I, Moscovici M, Saltz LB. Phase II study of sorafenib in patients with advanced hepatocellular carcinoma. J Clin Oncol. 2006 Sep 10;24(26):4293-300. doi: 10.1200/JCO.2005.01.3441. Epub 2006 Aug 14.
• Rimassa L, Pressiani T, Boni C, Carnaghi C, Rota Caremoli E, Fagiuoli S, Foa P, Salvagni S, Cortesi E, Chiara Tronconi M, Personeni N, Bozzarelli S, Chiara Banzi M, Fanello S, Romano Lutman F, Giordano L, Santoro A. A phase II randomized dose escalation trial of sorafenib in patients with advanced hepatocellular carcinoma. Oncologist. 2013;18(4):379-80. doi: 10.1634/theoncologist.2012-0221. Epub 2013 Apr 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sorafenib	Small molecule	600 mg	—

Indications