Skip to main content

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
Back to article page

Clinical Epigenetics

ISSN: 1868-7083

Contact us