Sorafenib PK in Patients With Advanced HCC and Child-Pugh B
Status:
Terminated
Trial end date:
2017-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)