Table 3.
Mean (SD) Pharmacokinetic Parameters of Trabectedin
| Dose Cohort, mg/m2 |
||||||
|---|---|---|---|---|---|---|
| 0.4 (n = 3) |
0.6 (n = 3) |
0.75* (n = 2) |
0.9 (n = 3) |
1.1 (n = 9) |
1.3 (n = 5) |
|
| Tmax, h | 2.40 | 1.93 | 1.50, | 2.83 (0.0) | 1.71 (0.93) | 2.60 |
| (0.77) | (0.78) | 1.50 | (0.62) | |||
| Cmax, ng/mL | 2.30 | 3.47 | 4.76, | 6.24 | 7.87 (2.04) | 7.71 |
| (0.46) | (0.51) | 3.43 | (0.69) | (1.66) | ||
| AUC∞,† | 9.86 | 19.2 | 28.6, | 37.6 | 53.5 | 53.2 |
| ng•h/mL | (1.57) | (8.34) | 13.1 | (2.08) | (22.2)‡ | (10.8) |
| CL, L/h | 74.5 | 70.9 | 51.2, | 45.5 | 40.8 | 48.4 |
| (8.88) | (29.4) | 78.2 | (6.49) | (14.8)‡ | (10.7) | |
| Vss, L | 744 | 1595 | 1915, | 2395 | 2643 | 3093 |
| (453) | (1075) | 1141 | (1103) | (1219)‡ | (411) | |
| t½, h | 19.6 | 43.1 | 54.4, | 75.6 | 93.0 | 83.2 |
| (5.43) | (37.4) | 27.0 | (15.7) | (36.2)‡ | (8.25) | |
Abbreviations: SD, standard deviation; Tmax, time to peak plasma concentration; Cmax, peak plasma concentration; AUC∞, area under plasma concentration-time curve; CL, clearance; Vss, volume of distribution at steady state; t½, half-life.
*
Individual parameter values provided.
†
From 0 to infinity.
‡
N = 8.