drugset / Trial / NCT01087021

Effect of Cabazitaxel on the QTc Interval in Cancer Patients

NCT01087021

Phase 1 Completed 45 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

Summary

Primary Objective: * To assess the potential effect on QTcF interval (QTc Fridericia) of cabazitaxel in cancer patients Secondary Objectives: * To assess the effects of cabazitaxel on heart rate (HR), QT, QTcB (Bazett's correction), and QTcN (population specific correction) intervals * To assess the clinical safety of cabazitaxel * To assess cabazitaxel plasma concentrations at Cycle 1 at early timepoints (during infusion and up to 5h post end of infusion)

Timeline

Start
2010-03
Primary completion
2011-04
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Cabazitaxel Other / unclassified 25 mg/m2 Intravenous

Indications