Table 4.
Hu14.18K322A Pharmacokinetic Parameters for Course One Based on Two-Compartment Model
Dose (mg/m2 per day) | No. Of Patients | CL (L/day) |
Cmax (mg/L) |
AUC0- (mg × day/L) |
T1/2α (day) |
T1/2β (day) |
Vc (L) |
||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Median | Range | Median | Range | Median | Range | Median | Range | Median | Range | Median | Range | ||
2 | 4 | 0.87 | 0.34-1.39 | 1.37 | 0.42-2.46 | 9.37 | 4.14-16.24 | 1.41 | 1.02-1.58 | 15.11 | 5.67-23.60 | 3.52 | 1.37-6.67 |
4 | 3 | 0.50 | 0.38-0.57 | 4.39 | 2.94-7.46 | 23.77 | 17.34-35.98 | 1.74 | 1.71-1.75 | 30.60 | 29.70-36.00 | 1.38 | 1.19-1.99 |
6 | 5 | 0.83 | 0.57-1.48 | 5.42 | 4.90-7.54 | 34.71 | 30.81-50.80 | 1.45 | 1.10-1.96 | 11.50 | 4.89-17.40 | 3.00 | 2.17-5.57 |
10 | 3 | 0.75 | 0.61-0.99 | 8.94 | 6.42-9.21 | 53.77 | 43.32-57.82 | 1.67 | 0.95-2.16 | 13.50 | 13.30-68.30 | 2.36 | 2.01-4.00 |
20 | 3 | 0.82 | 0.49-0.95 | 20.09 | 14.01-20.49 | 97.17 | 95.38-129.98 | 1.70 | 1.65-1.96 | 9.52 | 6.01-128.00 | 2.34 | 2.22-3.64 |
40 | 3 | 1.23 | 0.81-2.20 | 25.28 | 23.57-27.11 | 146.91 | 127.48-150.31 | 1.91 | 1.54-2.15 | 46.70 | 36.90-112.00 | 3.66 | 2.83-7.83 |
50 | 3 | 0.70 | 0.60-0.80 | 46.53 | 33.45-53.52 | 231.92 | 190.61-268.01 | 1.85 | 1.33-2.13 | 62.60 | 34.50-79.60 | 2.35 | 1.77-2.57 |
60 | 11 | 0.72 | 0.45-1.06 | 59.15 | 25.03-74.44 | 302.10 | 168.84-428.03 | 1.85 | 1.33-2.13 | 13.50 | 6.92-201.00 | 2.08 | 1.45-4.19 |
70 | 2 | 0.74 | 0.70-0.77 | 67.63 | 61.56-73.70 | 341.00 | 326.00-356.00 | 1.75 | 1.58-1.92 | 146.05 | 21.10-271.00 | 2.18 | 1.87-2.49 |
All | 37 | 0.75 | 0.34-2.20 | 23.57 | 0.42-74.44 | 129.98 | 4.14-428.03 | 1.74 | 0.95-2.21 | 21.10 | 4.89-271.00 | 2.36 | 1.19-7.83 |
Abbreviations: AUC0-, area under the concentration-time curve from time zero to infinity; Cmax, maximum plasma concentration; CL, clearance; T1/2α, half-life alpha; T1/2β, half-life beta; Vc, volume of distribution.