Table 4.
Pharmacokinetic parameters for LJM716 (Cycle 1; Cycle 3)
| AUC0–last (h·μg/mL) | C min (μg/mL) | C max (μg/mL) | T max (h) | |
|---|---|---|---|---|
| Cycle 1 | Mean (SD) | Median (range) | ||
| 10 mg/kg (n = 3) |
18,700 (7100) |
65.8 (27.3) |
195 (53.9) |
4.38 (2.83‒9.57) |
| 20 mg/kg (n = 3) |
33,700 (5120) |
137 (27.8) |
362 (53.4) |
4.63 (2.07‒9.65) |
| 40 mg/kg (n = 6) |
59,000 (21,500) |
243 (100) |
628 (136) |
3.75 (2.02‒9.65) |
| Cycle 3 a | Individual data | |||
| 10 mg/kg (n = 2) |
35,300; 62,400 | 185; 280 | 268; 615 | 9.50; 9.53 |
| 40 mg/kg (n = 1) |
243,000 | 1210 | 2130 | 4.73 |
AUC 0–last area under the curve from time zero to the time of the last quantifiable concentration, C max maximum observed serum concentration after drug administration, C min minimum drug serum concentration, SD standard deviation, T max time to reach C max
aThe number of available patients was limited in Cycle 3