Table 2.
Dose escalation scheme for weekly WX-UK1 infusions given in combination with a fixed dose (2000 mg/m2/d) of capecitabine
| Dose level | Dose (mg/kg) | % Difference from prior dose | Dose ratea (mg/kg/min) | Solution concentrationb (mg/ml) | Total amount of WX-UK(mg)b | No. of infusions per course |
|---|---|---|---|---|---|---|
| 1 | 0.3 | NA | 0.0025 | 0.024 | 24 | 3 |
| 2 | 0.6 | 100 | 0.0050 | 0.048 | 48 | 3 |
| 3 | 1.0 | 67 | 0.0083 | 0.080 | 80 | 3 |
| 4 | 1.5 | 50 | 0.0125 | 0.120 | 120 | 3 |
| 5 | 2.1 | 40 | 0.0175 | 0.168 | 168 | 3 |
| 6 | 2.8 | 33 | 0.0233 | 0.224 | 224 | 3 |
| 7 | 3.5 | 25 | 0.0292 | 0.280 | 280 | 3 |
a
Intravenous infusions were given via a central or peripheral catheter. The total volume of 1000 ml was given over 2 h at a rate of 500 ml/h by means of an infusion pump.
b
For an 80-kg subject.