Active Ingredient: CABAZITAXEL
Cabazitaxel is a second-generation taxane antineoplastic agent that demonstrates no clinically significant effect on cardiac repolarization or QTc intervals. In a dedicated cardiovascular safety study of patients with advanced solid tumors treated at 25 mg/m2, the maximum upper bound of the 90% confidence interval for mean QTcF change from baseline was 7.46 ms (mean increase 4.8 ms), successfully remaining below the regulatory 10 ms threshold. Pharmacokinetic-pharmacodynamic modeling revealed a slightly negative slope (-0.012), confirming the absence of exposure-dependent repolarization delay, with no adverse effects on PR, QRS, or heart rate.
https://doi.org/10.1007/s00280-014-2460-6