Active Ingredient: RAMUCIRUMAB
Ramucirumab is a human IgG1 monoclonal antibody targeting VEGFR-2 that demonstrates no clinically or statistically significant effect on cardiac repolarization or QTc intervals. In a phase 2 study following ICH E14 guidelines in patients with advanced cancer (10 mg/kg every 21 days for 3 cycles, with moxifloxacin positive control), the upper limit of the two-sided 90% confidence interval for mean QTcF change remained strictly below 10 ms at all postdose time points. Concentration-QTcF modeling confirmed an absence of exposure-dependent repolarization delay.
https://doi.org/10.1634/theoncologist.2015-0467