Table 4:
PK Parameters by Infusion Schedule
| 4-day schedule (N=9) |
2-day schedule (N=20) |
Overall (N=29) |
Test p-value Median* | |
|---|---|---|---|---|
| BSA (m 2 ) | ||||
| Mean (SD) | 1.59 (0.331) | 1.82 (0.317) | 1.75 (0.333) | |
| Median [Min, Max] | 1.65 [0.860, 2.04] | 1.79 [1.31, 2.39] | 1.70 [0.860, 2.39] | |
| Delivered Dose (mg) | ||||
| Mean (SD) | 111 (23.2) | 120 (29.4) | 118 (27.5) | |
| Median [Min, Max] | 116 [60.0, 143] | 119 [55.0, 169] | 116 [55.0, 169] | |
| CL (L/Day/m 2 ) | ||||
| Mean (SD) | 0.746 (0.0537) | 0.852 (0.153) | 0.819 (0.139) | |
| Median [Min, Max] | 0.729 [0.693, 0.829] | 0.792 [0.666, 1.27] | 0.788 [0.666, 1.27] | 0.053 |
| V1 (L/m 2 ) | ||||
| Mean (SD) | 1.58 (0.320) | 2.43 (1.41) | 2.17 (1.24) | |
| Median [Min, Max] | 1.46 [1.27, 2.09] | 1.84 [1.13, 6.84] | 1.81 [1.13, 6.84] | 0.053 |
| T1/2 Alpha (days) | ||||
| Mean (SD) | 0.720 (0.106) | 0.946 (0.339) | 0.876 (0.304) | |
| Median [Min, Max] | 0.684 [0.615, 0.885] | 0.810 [0.566, 1.89] | 0.800 [0.566, 1.89] | 0.053 |
| T1/2 Beta (days) | ||||
| Mean (SD) | 7.62 (0.138) | 7.48 (0.162) | 7.53 (0.165) | |
| Median [Min, Max] | 7.65 [7.42, 7.76] | 7.49 [7.25, 7.86] | 7.50 [7.25, 7.86] | 0.059 |
| AUC (mg * hr/L) | ||||
| Mean (SD) | 2261 (158) | 1911 (419) | 2019 (392) | |
| Median [Min, Max] | 2304 [2027, 2440] | 2038 [904, 2514] | 2136 [904, 2514] | 0.018 |
| Cmax (mg/L) | ||||
| Mean (SD) | 14.5 (2.54) | 19.7 (5.74) | 18.1 (5.51) | |
| Median [Min, Max] | 13.6 [11.7, 19.3] | 21.3 [7.58, 26.3] | 18.4 [7.58, 26.3] | 0.010 |
*
Kruskal-Wallis test with a null hypothesis that medians by dose schedule are equal.