Table 4.
Dose Level | Day 7 | Day 14 | Day 21 | Day 28 | Css | ||
---|---|---|---|---|---|---|---|
15 mg/m2 | |||||||
N = 14 | N = 14 | N = 13 | N = 11 | ||||
Sunitinib | Median | 27.8 | 29.7 | 37.7 | 22.5 | 28.0 | |
Min | 13.4 | 11.9 | 8.9 | 16.1 | 13.2 | ||
Max | 50.4 | 61.9 | 64.2 | 69.7 | 57.9 | ||
Total Drug | Median | 36.9 | 42.5 | 43.7 | 34.9 | 38.8 | |
Min | 22.0 | 19.5 | 10.1 | 15.6 | 21.0 | ||
Max | 69.7 | 94.2 | 90.5 | 90.5 | 83.8 | ||
Number with total drug concentration > 50 ng/mL | 6 | 5 | 6 | 4 | 5 | ||
20 mg/m2 | N = 9 | N = 8 | N = 8 | N = 7 | |||
Sunitinib | Median | 35.9 | 31.0 | 37.4 | 46.7 | 36.5 | |
Min | 23.1 | 26.9 | 24.2 | 23.4 | 28.2 | ||
Max | 55.1 | 58.6 | 62.9 | 86.2 | 65.0 | ||
Total Drug | Median | 48.2 | 45.4 | 49.3 | 66 | 50.6 | |
Min | 32.8 | 39.2 | 41.1 | 34.5 | 43.2 | ||
Max | 83.2 | 90.5 | 104.7 | 147.3 | 106.4 | ||
Number with total drug concentration > 50 ng/mL | 4 | 2 | 4 | 6 | 5 |
Absolute doses received per assigned dose level: 15 mg/m2 dose level - 12.5 mg (n = 4), 25 mg (n = 10); 20 mg/m2 dose level - 12.5 mg (n = 1), 25 mg (n = 7), 37.5 mg (n = 1).