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Br J Cancer. 2013 Jan 15;108(1):21-4. doi: 10.1038/bjc.2012.556. Epub 2013 Jan 3.

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

Author information

1
Medical Oncology and Hematology Unit, Humanitas Cancer Center, Istituto Clinico Humanitas IRCCS, Via Manzoni 56, 20089 Rozzano (Milan), Italy.

Abstract

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.

PMID:
23287988
PMCID:
PMC3553536
DOI:
10.1038/bjc.2012.556
[Indexed for MEDLINE]
Free PMC Article

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