Spots Global Cancer Trial Database for Pharmacokinetics (PK) of TKI258 in Cancer Patients With Normal and Impaired Hepatic Function

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Trial Identification

Brief Title: Pharmacokinetics (PK) of TKI258 in Cancer Patients With Normal and Impaired Hepatic Function

Official Title: A Multi-center, Open Label Study to Assess Pharmacokinetics of TKI258 in Adult Cancer Patients With Normal and Impaired Hepatic Function

Study ID: NCT01443481

Conditions

Solid Tumors

Hepatic Impairment

Interventions

Dovitinib

Study Description

Brief 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.

Detailed Description: