Table III.
Satraplatin day 1 pharmacokinetic parameters
| Dose level (mg/m2) |
Patient No. |
Age (years) |
BSA (m2) |
Actual dose (mg) |
Actual dose/m2 (mg/m2) |
Deviation (%)# |
Tmax (hr) |
Cmax (mcg/ml) |
AUC0–24h (mcg/ml*h) |
AUC0–inf (mcg/ml*h) |
T1/2 (h) |
Cl F (ml/min/m2) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 60 | 1 | 17 | 1.47 | 90 | 61.22 | 2.04 | 2 | 0.12 | 0.83 | 1.03 | 13.2 | 990.0 |
| 60 | 2 | 13 | 1.22 | 70 | 57.38 | −4.37 | 2 | 0.27 | 1.85 | 3.02 | 23.9 | 317.0 |
| 60 | 3 | 19 | 1.73 | 100 | 57.80 | −3.66 | 0.5 | 0.13 | 0.97 | 1.18 | 10.7 | 819.0 |
| 60 | 8 | 18 | 1.55 | 90 | 58.06 | −3.23 | 1 | 0.12 | 0.98 | 1.34 | 15.4 | 720.0 |
| Mean | 1.4 | 0.16 | 1.16 | 1.64 | 15.8 | 711.5 | ||||||
| SD | 0.8 | 0.07 | 0.47 | 0.93 | 5.7 | 285.7 | ||||||
| Median | 1.5 | 0.13 | 0.98 | 1.26 | 14.3 | 769.5 | ||||||
| 80 | 5 | 8 | 0.94 | 80 | 85.11 | 6.38 | 3 | 0.11 | 0.81 | 0.92 | 10.0 | 1,549.0 |
| 80 | 6* | 19 | 1.67 | 130 | 77.84 | −2.69 | 2 | 0.21 | 1.53 | 1.91 | 12.5 | 680.0 |
| 80 | 7* | 12 | 1.23 | 100 | 81.30 | 1.63 | 1 | 0.17 | 0.71 | 0.93 | 17.1 | 1,461.0 |
| Mean | 2.0 | 0.16 | 1.02 | 1.25 | 13.2 | 1,230.0 | ||||||
| SD | 1.0 | 0.05 | 0.45 | 0.57 | 3.6 | 478.3 | ||||||
| Median | 2.0 | 0.17 | 0.81 | 0.93 | 12.5 | 1,461.0 | ||||||
Abbreviations: BSA=body surface area, Tmax=time to peak concentration, Cmax=peak concentration, AUC0–24h= area under the concentration × times curve 0–24 hours, AUC0–inf = area under the concentration × times curve extrapolated to infinity, T1/2= terminal half life, Cl F= apparent clearance, SD=standard deviation.
#
Deviation of actual dose/m2 from dose level.
*
Patients with DLTs