Table 3.
Sonidegib plasma exposure in pediatric patients at days 1 and 22 of cycle 1 by dose cohort
| Sonidegib Dose Level (Once Daily) | Cycle 1, Day 1 | Cycle 1, Day 22 | ||||
|---|---|---|---|---|---|---|
| Cmax (ng/mL) n mean (SD) |
AUC0-24h (ng*hr/mL) n mean (SD) |
Tmax (h) n median (min;max) |
Cmax (ng/mL) n mean (SD) |
AUC0-24h (ng*hr/mL) n mean (SD) |
Tmax (h) n median (min;max) |
|
| 233 mg/m2 | 11 | 11 | 11 | 9 | 9 | 9 |
| 191 (82) | 1982 (737) | 4.0 (1.1;6.8) | 769 (496) | 10,590 (4163) | 2.0 (1.0;7.0) | |
| 372 mg/m2 | 15 | 15 | 15 | 12 | 14 | 12 |
| 246 (211) | 2194 (1592) | 2.0 (1.0;7.0) | 944 (553) | 15,431 (10,433) | 2.1 (1.0;4.3) | |
| 425 mg/m2 | 10 | 11 | 10 | 9 | 9 | 9 |
| 642 (487) | 5309 (3247) | 2.9 (0.5;7.0) | 1122 (737) | 17,753 (11,552) | 2.0 (0.7;7.0) | |
| 680 mg/m2 | 17 | 19 | 17 | 15 | 15 | 15 |
| 618 (403) | 5118 (2658) | 2.1 (1.0;4.1) | 1930 (678) | 32,623 (11,671) | 2.0 (0.0;7.1) | |