Table 3.
Dose | Cycle, day | No. of patients | Cmax (ng/mL) | AUClast (min·ng/mL) | AUC0–∞ (min·ng/mL) | % AUCextrap | t1/2 (min) | Vz (mL) | CL (mL/min) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
GM | CV | GMR | GM | CV | GMR | GM | CV | GMR | GM | CV | GM | CV | GM | CV | GM | CV | |||
1 μg/kg | C1D1 | 6 | 17.5 | 33.8 | NA | 1134 | 57 | NA | 1262 | 59 | NA | 9 | 36 | 30 | 78 | 3169 | 26 | 72 | 86 |
C1D3 | 6 | 21 | 36.6 | 1.2 | 1410 | 51 | 1.24 | 1553 | 49 | 1.23 | 9 | 37 | 34 | 55 | 2917 | 21 | 59 | 82 | |
C2D1 | 2 | 11.7 | 79.9 | 0.67 | 665 | 92 | 0.59 | 836 | 79 | 0.66 | 15 | 87 | 36 | 15 | 7320 | 78 | 142 | 87 | |
2 μg/kg | C1D1 | 2 | 41.2 | 19 | NA | 2963 | 41 | NA | 3089 | 41 | NA | 4 | 9 | 38 | 26 | 1153 | 31 | 21 | 55 |
C1D3 | 2 | 41.4 | 36.1 | 1 | 3374 | 34 | 1.14 | 3531 | 33 | 1.14 | 4 | 33 | 39 | 12 | 1068 | 37 | 19 | 47 | |
1 μg/kg | All days | 6 | 17.9 | 39.4 | NA | 1154 | 56 | NA | 1300 | 55 | NA | 9.8 | 61 | 33 | 60 | 3447 | 73 | 73 | 87 |
2 μg/kg | All days | 2 | 41.3 | 23.8 | 2.31 | 3162 | 31 | 2.74 | 3303 | 31 | 2.54 | 4.2 | 21 | 38 | 16 | 1110 | 28 | 20 | 43.2 |
IL-13-PE, interleukin-13-Pseudomonas exotoxin; Cmax, maximum serum concentration; t1/2, terminal half-life; AUClast, area under the curve from time 0 to last quantifiable time point; AUC0–∞, area under the curve extrapolated from time 0 to infinity; % AUCextrap, percentage AUC extrapolation; Vz, volume of distribution; CL, clearance; CV, coefficient of variation; GMR, geometric mean ratio; NA, not applicable.