Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment
Status:
Completed
Trial end date:
2014-07-01
Target enrollment:
Participant gender:
Summary
Primary Objectives:
- To determine the maximum tolerated dose (MTD) and safety of Cabazitaxel when
administered to advanced solid tumor patients with varying degrees of hepatic impairment
- To determine the pharmacokinetics (PKs) of Cabazitaxel in patients with varying degrees
of hepatic impairment
- To correlate PK variables with pharmacodynamic (PD) safety parameters in order to guide
prescribers with regard to dosing in this patient population
- To assess the effect of cabazitaxel at recommended dose of 25mg/m^2 on CYP3A enzyme
activity using midazolam as probe in an additional cohort of cancer patients with normal
hepatic function.