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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01443481
Study type Interventional
Source Novartis
Contact
Status Completed
Phase Phase 1
Start date November 2011
Completion date October 2014

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