Table 4.
ADC | MMAE | ||||||
---|---|---|---|---|---|---|---|
Study; Dose | Dose (mg/kg) | n | AUC (days µg/mL) |
Cmax (µg/mL) |
n | AUC (days ng/mL) | Cmax (ng/mL) |
Current Study (actual) |
1.2 | 16 | 37.97 (18) | 18.47 (14) | 16 | 24.08 (24) | 4.85 (16) |
Current Study (simulated) |
1.8 | 16 | 54.84 (18) | 28.82 (14) | 16 | 34.57 (24) | 7.29 (16) |
Fanale et al. 2012[2] |
1.2 | 12 | 40.52 (9)* | --- | 12 | 15.93 (60)* | 3.12 (60) |
Younes et al. 2010[9] |
1.2 1.8 |
4 12 |
46.14 (62) 79.41 (30) |
18.89 (27) 31.98 (29) |
4 12 |
20.29 (212) 37.03 (47) |
2.72 (272) 4.97 (43) |
Han et al. 2012 (Study 5)[15] |
1.2 1.8 |
11 11 |
52.77 (28) 89.84 (25) |
22.57 (23) 36.74 (34) |
14 14 |
26.65 (71) 40.06 (53) |
4.11 (71) 4.98 (67) |
AUC from day 0–7.