TABLE 4.
Dosing regimens evaluated in the dose fractionation study (in terms of total weekly dose)a
| Dosing frequency | Regimen used to achieve a total weekly dose (mg/kg) of: |
|||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 20 | 40 | 60 | 80 | 100 | 120 | 200 | 300 | 400 | 500 | 600 | 1,000 | 1,200 | 2,000 | 3,000 | 4,000 | |
| Study 1 | ||||||||||||||||
| 5× per wk (M–F) twice | 10 BID | 20 BID | 50 BID | 100 BID | 200 BID | 300 BID | 400 BID | |||||||||
| 5× per wk (M–F) | 20 QD | 40 QD | 100 QD | 200 QD | 400 QD | |||||||||||
| 3× per wk (M, W, F) | 20 TIW | 40 TIW | 100 TIW | 200 TIW | 400 TIW | |||||||||||
| 2× per wk (M, R) | 20 BIW | 40 BIW | 100 BIW | 200 BIW | ||||||||||||
| 1× per wk (M) | 20 QW | 40 QW | 100 QW | |||||||||||||
| Study 2 | ||||||||||||||||
| 5× per wk (M–F) twice | 50 BID | 200 BID | ||||||||||||||
| 5× per wk (M–F) | 100 QD | |||||||||||||||
| 3× per wk (M, W, F) | 166 TIW | 333 TIW | ||||||||||||||
a
Individual dose per kilogram of body weight administered per dosing occasion and dosing frequency. For comparison with regard to dose fractionation, equal weekly doses are given. Abbreviations: M, Monday; T, Tuesday; W, Wednesday; R, Thursday; F, Friday; BID, twice daily; QD, once daily; TIW, three times weekly; BIW, twice weekly; QW, once weekly.