NCT01443481

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumors
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Dovitinib	Starting dose to be determined based on the study outcome of the mild and moderate hepatic impairment groups

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2011-09-29
• Last updated: 2020-12-21

Locations

12 sites across 6 countries: United States, Belgium, Germany, Italy, Netherlands, Singapore