Sorafenib PK in Patients With Advanced HCC and Child-Pugh B

Summary

Sorafenib has proven efficacy in advanced hepatocellular carcinoma (HCC). Most patients with HCC have impaired liver function due to underlying liver cirrhosis. The severity of liver cirrhosis might have implications on sorafenib metabolism. To date, no data showing unequivocal activity and tolerability of sorafenib in patients with moderate cirrhosis (Child-Pugh (CP)-B) have been published. To specifically address this issue, this study aims to explore population pharmacokinetics of sorafenib and to explore the relationship between sorafenib exposure and its efficacy and toxicity in CP-B patients with irresectable HCC.

Timeline

Start

2014-05

Primary completion

2017-03

Completion

2017-03

Outcome

Outcome not reported

Stopped (Enrollment): “Slow accrual.”

Drugs

Indications