Table 6.
Summary pharmacokinetics parameters of selumetinib on day 1 of cycle 1
| Dose level 1 and 2 combined (N=10) | Dose level 3 (N=22a) | p-value | |
|---|---|---|---|
| Cmax (ng/mL) | 1212 (CV 0.24) | 1504 (CV 0.40) | 0.08 |
| AUC 0-∞ (ng/mL × hr) | 3448 (CV 0.17) | 5200 (CV 0.58) | 0.01 |
| Log (Cmax (ng/mL) – dose normalized | 3.19 ± 0.23 | 3.00 ± 0.43 | 0.20 |
| Log(AUC 0-∞ (ng/mL × hr) – dose normalized | 4.23 ± 0.17 | 4.24 ± 0.54 | 0.97 |
Data are shown as geometric mean and coefficient of variation (CV) for Cmax and AUC, and as mean ± standard deviation for log-transformed, dose normalized Cmax and AUC.
a
Includes patients at dose level 3 and the dose expansion cohort