Table 3.
Pharmacokinetics of Romidepsin
| Parameter | 14 mg/m2 |
18 mg/m2 |
||||
|---|---|---|---|---|---|---|
| No. of Patients* | Geometric Mean | 95% CI | No. of Patients | Geometric Mean | 95% CI | |
| Half-life, hours | 42 | 2.95† | 2.49 to 3.49 | 3 | 2.56 | 1.62 to 4.05 |
| Cmax, ng/mL‡ | 61 | 361.52 | 313.49 to 416.92 | 3 | 722.18 | 366.93 to 1,421.38 |
| AUClast, h·ng/mL | 61 | 1,214.23 | 1,044.16 to 1,412.01 | 3 | 2,571.05 | 1,258.64 to 5,251.92 |
| AUCinf, h·ng/mL | 42 | 1,456.54 | 1,250.74 to 1,696.21 | 3 | 2,582.65 | 1,263.23 to 5,280.17 |
| Vzobs, L/m2 | 42 | 40.89 | 33.40 to 50.06 | 3 | 25.75 | 13.16 to 50.36 |
| Clobs, L/h/m2§ | 42 | 9.61 | 8.25 to 11.19 | 3 | 6.97 | 3.40 to 14.27 |
Abbreviations: Cmax, maximum plasma concentration; AUClast, area under the curve from time zero to time of final quantifiable sample; AUCinf, area under the curve extrapolated to infinity; Vz obs, volume of distribution during the terminal phase; Clobs, observed clearance.
*
Pharmacokinetic analysis was not possible in seven patients, and a full analysis was not possible in 19 patients.
†
The median half-life was 2.64 hours (range, 1.0 to 10.9 hours).
‡
Cmax is reported as observed value.
§
Clearance is expressed as L/hour/m2 because of the body-surface area dosing used.