Table 4

Pharmacokinetic parameters

a. i.v. SAHA
Dose levelnCmax (ng/ml) Mean ± SDT1/2 (min) Mean ± SDAUCinf (h × ng/ml) Mean ± SDVz liters/m2 Mean ± SDCl liters/h/m2 Mean ± SD
75 mg/m2
 Day 117702115012449
 Day 31683AbAAA
150 mg/m2
 Day 111649AAAA
 Day 3116312128622856
300 mg/m2
 Day 1112646 ± 58833 ± 274285 ± 115062 ± 5675 ± 21
 Day 3123391840273375
 Day 5124083846345965
 Day 123a2721 ± 9442145923265
 Day 1962963 ± 55937 ± 125053 ± 115957 ± 2762 ± 13
600 mg/m2
 Day 196334 ± 308658 ± 3811233 ± 6928103 ± 10166 ± 25
 Day 3141673575846779
 Day 1958628 ± 547572 ± 3016697 ± 1152385 ± 4945 ± 16
900 mg/m2
 Day 1119525 ± 161146 ± 2816611 ± 453366 ± 5060 ± 19
 Day 19614169 ± 201050 ± 2729198 ± 872342 ± 2236 ± 16
b. i.v. SAHA for solid tumor and hematological patients
Dose levelnCmax (ng/ml) Mean± SDT1/2 (h) Mean± SDAUCinf (h× ng/ml) Mean± SDVz liters/m2 Mean± SDCl liters/h/m2 Mean± SD
Solid (300 mg/m2)
 Day 182650 ± 65622 ± 44434 ± 127840 ± 2174 ± 24
 Day 1933298 ± 43828 ± 105725 ± 129835 ± 1054 ± 12
Hematologic (300 mg/m2)
 Day 142638 ± 51553 ± 394026 ± 1002101 ± 8178 ± 17
 Day 1932627 ± 50147 ± 54382 ± 56478 ± 1769 ± 9
Solid (600 mg/m2)
 Day 145674 ± 54538 ± 129341 ± 110759 ± 1765 ± 8
 Day 1925347 ± 76080 ± 2910832 ± 500107 ± 4455 ± 3
Hematologic (600 mg/m2)
 Day 156862 ± 424674 ± 4512748 ± 9414137 ± 12966 ± 34
 Day 19310815 ± 645966 ± 3620606 ± 1442670 ± 5538 ± 18
  • a Includes number of patients having pharmacokinetics studies during cycles 1 and 2.

  • bA, missing data points to adequately calculate parameters.