Table 3.
Pharmacokinetic results for high-dose, pulsatile sorafenib
| Cohort | No. of patients | Target AUC(0–12 h) (mg/L/h) | Fixed dose week 1 (mg) | PK-guided dose week 3 (mg), mean (± SD) | Observed AUC(0–12 h) week 1 (mg/L/h), mean (± SD) | Observed AUC(0–12 h) week 3 (mg/L/h), mean (± SD) | Cmax week 1 (μg/L), mean (± SD) | Cmax week 3 (µg/L), mean (± SD) |
|---|---|---|---|---|---|---|---|---|
| 1 | 3 | 25–50 | 1000 | 533 (± 306) | 78 (± 22) | 31 (± 13) | 9089 (± 3281) | 4385 (± 1312) |
| 2 | 8 | 75–100 | 2000 | 1867 (± 993) | 125 (± 59) | 102 (± 49) | 13,696 (± 5866) | 11,098 (± 6115) |
| 3 | 3 | 100–125 | 2400 | 2333 (± 219) | 204 (± 113) | 96 (± 40) | 20,829 (± 11,234) | 13,280 (± 5310) |
| 4 | 3 | 125–150 | 2800 | NA* | 120 (± 13) | NA* | 15,200 (± 1266) | NA* |
*NA not applicable