Table 4.

Flavopiridol pharmacokinetic parameters for patients with evaluable PK profiles

Dose level (mg/m2)	n	PK	Mean AUC0-∞ ± SD Median [range], hr*µM	Mean CL ± SD Median [range], L/hr	Mean Cmax ± SD Median [range], µM	Mean Vz ± SD Median [range], L	Mean T1/2 ± SD Median [range], hr	Mean Tmax ± SD Median [range], hr
30 + 30	5	Day 1: 5	7.78 ± 2.75	39.97 ± 20.87	1.85 ± 0.80	367.9 ± 210.1	6.87 ± 3.24	0.52 ± 0.03
		Day 22: 2	7.64 [3.69–11.59]	35.11 [20.22–80.18]	1.83 [1.01–3.09]	265.1 [211.6–764.0]	6.44 [3.03–13.36]	0.50 [0.50–0.57]
30+50	3	Day 1: 3	4.75 ± 1.06	77.05 ± 12.31	1.09 ± 0.43	417.2 ± 242.2	3.65 ± 1.75	1.18 ± 1.22
		Day 22: 1	4.92 [3.39–5.77]	77.23 [64.81–88.91]	0.92 [0.80–1.72]	346.7 [209.6–765.5]	3.16 [2.13–6.15]	0.61 [0.50–3.00]
50+50	7	Day 1: 6	14.18 ± 5.34	38.56 ± 14.26	2.41 ± 0.74	316.6 ± 254.9	5.35 ± 2.83	1.40 ± 1.67
		Day 22: 4	13.82 [7.10–22.56]	35.31 [22.08–59.96]	2.55 [1.31–3.62]	214.4 [100.8–886.5]	4.24 [3.00–12.06]	0.58 [0.50–4.63]

Summary of non-compartmental PK parameter estimates by dose levels for cycle 1 day 1 and cycle 1 day 22 combined. N is the number of treated patients per dose level while PK is the number of evaluable PK profiles by day included in the mean and standard deviation (SD) calculations. Data is presented as mean ± SD (1st line) and median [range] (2nd line). Abbreviations: AUC _0-∞, estimated area under the flavopiridol concentration vs. time curve from zero to infinity; CL, total body clearance; C_max, maximum observed concentration; Vz, apparent volume of distribution based on terminal phase; T_1/2, terminal phase elimination half-life; T_max, time corresponding to C_max; SD, standard deviation.