Table 4.

Pharmacokinetic parameter estimates based on cycle 1 data

Dose (mg/kg)Patient (n)AUC(0-28) (days*μg/mL)Cmin (μg/mL)*Cmax (μg/mL)CL (mL/d/kg)Vz (mL/kg)t1/2 (d)
13220 ± 55.93.5 ± 1.426.1 ± 6.23.6 ± 0.973.5 ± 17.114.5 ± 2.0
43980 ± 33116.8 ± 9.699.4 ± 13.73.1 ± 1.778.8 ± 19.519.3 ± 4.9
10131500 ± 41827.7 ± 14.4210 ± 47.0§6.4 ± 2.180.1 ± 30.69.1 ± 2.8
1533310 ± 128043.9 ± 23.3330 ± 37.23.4 ± 1.874.4 ± 48.714.7 ± 8.9
2032140 ± 60551.3 ± 32.4333 ± 49.29.1 ± 4.295.1 ± 23.48.8 ± 5.7

NOTE: Cmin values are at day 28 of cycle 1. Some of patients missed their Cmin sampling; therefore, numbers of patients in 10 and 15 mg/kg groups with Cmin data are less than those for other pharmacokinetic parameters. Data expressed as mean ± SD.

Abbreviations: AUC, area under the curve from zero to day 28; Vz, volume of distribution; t1/2, terminal phase half-life.

  • *Pharmacokinetic parameters are derived from samples obtained at cycle 1 only.

  • Estimation of AUC(0-28) is based on data from 14 patients in this dose group.

  • Estimation is based on n = 4 patients.

  • §Estimation is based on n = 19 patients.

  • Estimation is based on n = 2 patients.