drugset / Trial / NCT01140607
Safety and Pharmacokinetic Study of Cabazitaxel in Patients With Advanced Solid Tumors and Liver Impairment
Non-randomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2010-05
- Primary completion
- 2014-07
- Completion
- 2014-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cabazitaxel | Other / unclassified | 5 mg/m2 | Intravenous |
| Subject | Cabazitaxel | Other / unclassified | 10 mg/m2 | Intravenous |
| Subject | Cabazitaxel | Other / unclassified | 20 mg/m2 | Intravenous |
| Subject | Cabazitaxel | Other / unclassified | 25 mg/m2 | Intravenous |