A Phase-1b study of tivantinib (ARQ 197) in adult patients with hepatocellular carcinoma and cirrhosis

A. Santoro, M. Simonelli, C. Rodriguez-Lope, P. Zucali, L. H. Camacho, A. Granito, N. Senzer, L. Rimassa, G. Abbadessa, B. Schwartz, M. Lamar, R. E. Savage, J. Bruix

Research output: Contribution to journalArticlepeer-review


Background:The mesenchymal-epithelial transition factor (MET) receptor is dysregulated in hepatocellular carcinoma (HCC), and tivantinib (ARQ 197) is an oral, selective, MET inhibitor.Methods:This Phase-1b study assessed tivantinib safety as primary objective in patients with previously treated HCC and Child-Pugh A or B liver cirrhosis. Patients received oral tivantinib 360 mg twice daily until disease progression or unacceptable toxicity.Results:Among 21 HCC patients, common drug-related adverse events (AEs) were neutropaenia, anaemia, asthenia, leucopaenia, anorexia, diarrhoea, and fatigue. No drug-related worsening of liver function or performance status occurred, but one Child-Pugh B patient experienced drug-related bilirubin increase. Four patients had drug-related serious AEs, including one neutropaenia-related death. Haematologic toxicities were more frequent than in previous tivantinib studies but were manageable with prompt therapy. Best response was stable disease (median, 5.3 months) in 9 of 16 evaluable patients (56%). Median time to progression was 3.3 months.Conclusion:Tivantinib demonstrated a manageable safety profile and preliminary antitumour activity in patients with HCC and Child-Pugh A or B cirrhosis.

Original languageEnglish
Pages (from-to)21-24
Number of pages4
JournalBritish Journal of Cancer
Issue number1
Publication statusPublished - Jan 15 2013


  • Hepatocellular carcinoma
  • liver cirrhosis
  • liver function
  • MET inhibitor
  • tivantinib

ASJC Scopus subject areas

  • Cancer Research
  • Oncology


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