Table 2.
Pharmacokinetic parameters
| Parameter, mean ± SD (geometric mean) [CV %] | Cohort A (normal renal function) 25 mg/m2 n = 8 |
Cohort B (moderate renal impairment) 25 mg/m2 n = 8 |
Cohort C (severe renal impairment) |
|
|---|---|---|---|---|
| 20 mg/m2
n = 4a |
25 mg/m2
n = 4b |
|||
| Non-compartmental analysis | ||||
| C max, ng/mL | 161 ± 57.0 (152) [35] |
241 ± 207c
(193) [86] |
135 ± 45.7 (130) [34] |
244 ± 150 (215) [62] |
| Individual modeling/three-compartmental analysis | ||||
| AUC, ng*h/mL | 787 ± 177 (766) [23] |
1070 ± 733 (938) [68] |
928 ± 475 (829) [51] |
857 ± 263 (823) [31] |
| CL, L/h | 58.9 ± 14.7 (57.5) [25] |
54.1 ± 21.9 (49.1) [41] |
51.8 ± 34.4 (44.8) [66] |
63.0 ± 30.5 (58.1) [48] |
| V ss, L | 7730 ± 3280 (7160) [42] |
6730 ± 2970 (6170) [44] |
5810 ± 1360 (5690) [23] |
6470 ± 3790 (5680) [59] |
| CL/BSA, L/h/m2 | 33.5 ± 9.76 (32.5) [29] |
28.9 ± 10.7 (26.5) [37] |
27.5 ± 17.1 (24.1) [62] |
31.7 ± 11.4 (30.3) [36] |
| V ss/BSA, L/m2 | 4230 ± 1360 (4040) [32] |
3580 ± 1480 (3320) [41] |
3130 ± 730 (3060) [23] |
3380 ± 1920 (2970) [57] |
| t 1/2γ3, h | 122 ± 43.8 (116) [36] |
143 ± 102 (124) [71] |
133 ± 84.4 (113) [63] |
115 ± 49.8 (103) [43] |
a n = 4; three patients were not included in the statistical analysis for Cycle 1 (20 mg/m2) because they were analyzed at Cycle 2 (25 mg/m2)
b n = 4; one patient was excluded from statistical analyses because the cabazitaxel dose was decreased to 15 mg/m2
c n = 7; one patient was excluded from the calculation of summary statistics because of a sampling time deviation at the end of infusion
AUC Area under the plasma concentration–time curve, CL clearance, CL/BSA clearance normalized to body surface area, C max maximum plasma concentration, CV coefficient of variation, SD standard deviation, t 1/2γ3 elimination half-life, V ss volume of distribution at steady state, V ss /BSA volume of distribution at steady state normalized to body surface area