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Table 3 Mean pharmacokinetic parameters of decitabine on day 5 of treatment—overall and by age group, pharmacokinetic analysis population

From: A multicenter, randomized study of decitabine as epigenetic priming with induction chemotherapy in children with AML

  Age group (years) Arm A Comparator Combined data from prior studies of decitabine in adults and children
Pharmacokinetic parameter 2–11 (N = 7) 12–16 (N = 4) Total (N = 11) 70-kg adult malea  
C max (ng/mL) 286 (131) 307 (36·9) 294 (104) 107 64·8–77·0
t max (h) 0·803 (0·272) 0·88 (0·243) 0·831 (0·253) NR End of infusion
t ½ (h) 0·458 (0·0777) 0·446 (0·0967) 0·453 (0·0804) 1·14 0·33–0·78
AUC0-t (ng h/mL) 211 (90·0) 218 (35·1) 214 (72·4) NR NR
AUC0-∞ (ng h/mL) 212 (90·0) 219 (35·7) 215 (72·5) 580b 152–163
CL (L/h) 110 (113) 161 (23·9) 128 (92·3) 298 125–132
Vdss (L) 40·7 (52·0) 54·1 (9·67) 45·5 (41·1) 116 36·88–52·47
  1. All values presented as mean ± SD. Standard deviation cannot be calculated where n = 2
  2. AUC area under the concentration-time curve, CL total body clearance, C max maximum concentration, NR not reported, t ½ half-life, t max time to C max, Vd ss volume of distribution at steady-state concentrations
  3. aData based on population pharmacokinetic analysis provided by Eisai Inc.
  4. bCumulative AUC value over entire 5-day dosing period. Single-day AUC value = 116 ng h/mL