Table 5.
Detailed day 1 pharmacokinetic parameters for sunitinib and SU12662 in 9 children and young adults treated with sunitinib.
| Dose Level | N | Sunitinib | SU12662 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Tmax (hours) | Cmax (ng/mL) | AUC0-48h (h·ng/L) | AUC0-∞ (h·ng/L) | Cl/F (L/hr/m2) | AR | Tmax (h) | Cmax (ng/mL) | AUC0-48h (h·ng/L) | AUC0-∞ (h·ng/L) | AR | |||
| 15 g/m2 | 8 | Median | 7.0 | 16.8 | 492 | 747 | 19.5 | 3.1 | 8.0 | 2.3 | 76 | 384 | 6.4 |
| Min | 2.0 | 9.5 | 247 | 298 | 6.8 | 2.2 | 4.0 | 1.5 | 38 | 202 | 3.4 | ||
| Max | 48.0 | 61.4 | 1111 | 5365 | 43.3 | 4.2 | 48.7 | 8.5 | 285 | 2605 | 11.1 | ||
| 20 mg/m2 | 1 | 8.0 | 26.3 | 698 | 879 | 19.9 | 2.00 | 8.0 | 5.3 | 206 | 522 | 4.2 | |
Calculations for sunitinib Cl/F reflect data from 6 patients. Tmax = time to maximum plasma concentration; Cmax = maximum plasma concentration; AUC0-∞ = AUC0-48h + C48h/kel, where kel (terminal elimination rate constant) was calculated by linear least squares regression of the linear terminal elimination phase of the graph of ln(plasma concentration) versus time. AR = accumulation ratio = Css/C24h.