Table 3. Exploratory Pharmacokinetic Summary From Patients Receiving Vatalanib Alone (Day 14), Vatalanib After Everolimus Started (Day 29), and Everolimus With Vatalanib (Day 29).
Agent | Vatalanib Alone | Vatalanib + Everolimus | Everolimus |
---|---|---|---|
Mean ± SD | Mean ± SD | Mean ± SD | |
t1/2(h) | 6.32 ± 4.46 | 5.71 ± 3.06 | 14.0 ± 2.5 |
tmax(h) | 2.00 (1.08-6.08)a | 2.08 (1.00-4.08)a | 1.31 (0.73-17.7)a |
Cssmax(ng/mL) | 4825 ± 2910 | 3963 ± 1861 | 48.5 ± 14.8 |
AUC (ng·h/mL) | 26,384 ± 13,201 | 21,626 ± 9778 | 377 ±117 |
Cssavg(ng/mL) | 1099 ± 551 | 901 ± 403 | 15.7 ± 4.9 |
CLss/F (L/h) | 53.7 ± 38.7 | 53.7 ± 38.7 | 14.3 ± 3.7 |
Vz/F (L) | 488 ± 481 | 488 ± 481 | 216 ± 74 |
Abbreviations: AUC = area under the plasma concentration vs. time curve; CL/F = oral clearance; Cssavg = steady-state plasma concentration; Cssmax = value of maximum plasma concentration; t1/2 = terminal phase rate constant and half-life; tmax = time to peak concentration; Vz/F = area volume of distribution after oral dosing.
Median.