Pharmacokinetics (PK) of TKI258 in Cancer Patients With Normal and Impaired Hepatic Function
Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
This is a multi-center, open label study to assess pharmacokinetics (PK) of TKI258 at
single-dose and steady state in adult cancer patients either with mild, moderate or severe
hepatic impairment or with normal hepatic function. Hepatic function in study patients will
be categorized as normal, mild, moderate or severe based upon pre-dose (Day 1) total
bilirubin and AST/ALT levels. Starting dose of TKI258 will depend on total bilirubin and
ALT/AST levels at baseline. Patients will be treated until disease progression (assessed by
RECIST 1.1), unacceptable toxicity, death or discontinuation from the study treatment for any
other reason.