Table 5.
Mean (SD) Pharmacokinetic Parameters of Ficlatuzumab (10 or 20 mg/kg) and Gefitinib (250 mg Daily)
| Ficlatuzumab dose | Cycle, Day | n | t1/2 (Days) | Cmax (μg/mL) | Tmax (h) | AUC0–last (mg·h/mL) |
|---|---|---|---|---|---|---|
| Ficlatuzumab parameters | ||||||
| 10 mg/kg | Cycle 1, day 1 | 3 | 15.2 (4.7) | 229 (8.9) | — | 39.2 (4.5) |
| 20 mg/kg | Cycle 1, day 1 | 12 | 11.3 (3.2) | 544 (141) | — | 81.3 (16.5) |
| 20 mg/kg | Cycle 4, day 1 | 6a | 17.8 (6.3)b | 1070 (220) | — | 212 (47.3) |
| Gefitinib parameters | ||||||
| 10 mg/kg | Cycle 1, day 1 | 3 | — | 250 (44.1) | 4.0 (0) | 3706 (1109) |
| 20 mg/kg | Cycle 1, day 1 | 12 | — | 245 (89.5) | 5.4 (1.9) | 3960 (1588) |
| 20 mg/kg | Cycle 4, day 1 | 6c | — | 377 (224) | 9.9 (6.7) | 6591 (4824) |
AUC0–last, area under the serum concentration–time curve from the time of dosing to the last measurable concentration; Cmax, maximal plasma concentration; SD, standard deviation; t1/2, half‐life; Tmax, time to Cmax.
a
Only 6 patients enrolled in the 20 mg/kg dosage group were treated in cycle 4.
b
Patient 6501‐000107 had a t1/2 of 74.0 days and was not included in the calculation of mean (SD) t1/2.
c
Only 6 patients enrolled in the 20 mg/kg dosage group were dosed in cycle 4.