Neoplasms, Malignant Clinical Trial
Official title:
QT-Cab: An Open-Label Study to Investigate the Effect of Cabazitaxel on the QTc Interval in Cancer Patients
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)
The main period of the study consists of a maximum of 21-day screening phase, then first 2
treatment cycles with cabazitaxel. End of main period will be Cycle 3 or 30 days after last
dose if patient discontinues study after 1 or 2 treatment cycles. The duration for a patient
for the main period of the study will be about 9 to 10 weeks (screening, 2 cycles).
After Cycle 2, patients will have the option to continue to receive cabazitaxel and should
be followed for safety reporting until 30 days after the last dose of cabazitaxel.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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