Table 4.
Summary of Cycle 1 IMC-A12 Pharmacokinetic (PK) Parameters
| IMC-A12 Dose Temsirolimus Dose |
6 mg/kg 8 mg/m2 (n=8) |
6 mg/kg 10 mg/m2 (n = 3) |
6 mg/kg 15 mg/m2 (n = 4) |
|||
|---|---|---|---|---|---|---|
| Median | Range | Median | Range | Median | Range | |
| Cmax (μg/mL) | 281 | (239–355) | 277 | (219–390) | 230 | (161–464) |
| Tmax (h) | 2.0 | (1.0–7.0) | 1.1 | (1.1–2.2) | 2.1 | (1.1–7.0) |
| t1/2 (h) | 98 | (64–161) | 122 | (88–133) | 130 | (98–446) |
| AUC0–7d (h•μg/L) | 20.6 | (11.6–29.7) | 25.6 | (20.6–28.7) | 26.4 | (14.8–34.0) |
| CL (mL/h) | 8.3 | (1.1–15.2) | 9.9 | (2.9–14.5) | 7.0 | (3.1–14.3) |
| CL (mL/h/kg) | 0.19 | (0.12–0.43) | 0.17 | (0.12–0.18) | 0.13 | (0.07–0.24) |
| Vdss (mL) | 1050 | (150–2390) | 1750 | (470–1840) | 1860 | (590–2400) |
| Vdss (mL/kg) | 25.8 | (20.8–40.3) | 22.7 | (20.7–29.4) | 31.1 | (18.6–42.3) |