Effect of Cabazitaxel on the QTc Interval in Cancer Patients

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi

Criteria

Inclusion criteria:

• Histologically or cytologically confirmed solid malignancy that is metastatic or unresectable, and for which standard curative measures do not exist, and a treatment with a novel taxane agent is considered.

Exclusion criteria:

• Conditions with screening ECG repolarization difficult to interpret, or showing significant abnormalities. This includes, but is not limited to: high degree AV block, pace-maker, atrial fibrillation or flutter

• QTcF >480 msec on screening Electrocardiogram (ECG)

• Significant hypokalemia at screening (serum potassium <3.5 mMol/L)

• Significant hypomagnesemia at screening (serum magnesium <0.7 mMol/L) (Note: Patient may be enrolled after correction of these laboratory abnormalities)

• Patient receives (and cannot discontinue), or is scheduled to receive a QT-prolonging drug

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.