Phase II study of two dose schedules of C.E.R.A. (Continuous Erythropoietin Receptor Activator) in anemic patients with advanced non-small cell lung cancer (NSCLC) receiving chemotherapy

Table 4 Pharmacokinetic values for C.E.R.A. after subcutaneous injection. Results are given as mean ± SD, apart from T_max and CL/F, which are given as median values.

C.E.R.A. dose group, μg/kg (n)	C_max (ng/mL)	T_max (h)	AUC (ng • h/mL)*	t_1/2 (h)	CL/F (mL/h/kg)
QW
0.7 (14)	6.7 ± 2.5	71	931 ± 358	171 ± 69^†	25.3
1.4 (16)	10.6 ± 4.1	74	1355 ± 548^‡	NC**	25.1
2.1 (15)	20.2 ± 8.7	70	2709 ± 1193	212 ± 200^†	23.4
Q3W
2.1 (18)	8.2 ± 3.8	120	2750 ± 1318	157 ± 38^†	34.7
4.2 (18)	16.6 ± 9.5	82	4651 ± 2569^‡	174 ± 44^†	42.8
6.3 (17)	20.9 ± 12.5	120	6547 ± 3957^‡	186 ± 78^†	49.4

AUC: area under the serum concentration-time curve.
C.E.R.A.: Continuous Erythropoietin Receptor Activator.
CL: clearance.
C_max: maximum serum concentration.
F: bioavailability.
QW: once weekly.
Q3W: once every 3 weeks.
SD: standard deviation.
T_max: time to C_max.
t_1/2: terminal half-life.
*AUC_{22–29 days} for QW group and AUC_{22–43 days} for Q3W group.
**NC, not calculated (n = 2).
^†n = 4 and 3 in 0.7 and 2.1 QW groups, respectively, and n = 11, 15, 14 in 2.1, 4.2, and 6.3 Q3W groups, respectively.
^‡n = 15, 16, and 14 for 1.4 QW. 4.2 Q3W, and 6.3 Q3W groups, respectively.

ISSN: 1745-6215