Correction to: Cancer Chemotherapy and Pharmacology (2020) 85:621–626 https://doi.org/10.1007/s00280-020-04037-9
In the original publication of the article the author has found few incorrect values in the Table 1. The corrected Table 1 is given below.
Table 1.
Food effect on the plasma pharmacokinetic parameters of the CC-486 300 mg Formulation B tablet
| Condition | Statistic | AUCt (ng h/mL) | AUC∞ (ng h/mL) | Cmax (ng/mL) | Tmax (h) | t1/2 (h) | CL/F (L/h) | Vz/F (L) |
|---|---|---|---|---|---|---|---|---|
| Fasted | N | 56 | 54 | 56 | 56 | 54 | 54 | 54 |
| Geometric Meana | 224.9 | 234.5 | 131.7 | NA | 0.58 | 1280 | 1074 | |
| Geometric %CV | 68.4 | 62.9 | 70.4 | NA | 31.6 | 62.9 | 76.2 | |
| Median | 240 | 243 | 141 | 1.0 | 0.55 | 1230 | 1140 | |
| Min, max | 41.5, 1050 | 65.9, 1050 | 21.4, 608 | 0.50, 4.0 | 0.35, 1.7 | 286, 4550 | 228, 6310 | |
| Fed | N | 55 | 44 | 55 | 55 | 46 | 44 | 44 |
| Geometric Meana | 233.7 | 248.9 | 105.2 | NA | 0.78 | 1205 | 1279 | |
| Geometric %CV | 58.3 | 52.0 | 76.3 | NA | 55.2 | 52.0 | 80.5 | |
| Median | 250 | 250 | 116 | 2.0 | 0.68 | 1200 | 1160 | |
| Min, Max | 61.3, 554 | 78.9, 560 | 22.7, 337 | 0.50, 6.1 | 0.40, 6.2 | 536, 3800 | 399, 9350 |
| PK parameter | Condition | N | Geometric mean† | Ratio (%) of geometric means | 90% CI of ratio (%) of geometric means | Intra-patient %CV |
|---|---|---|---|---|---|---|
| AUCt (ng h/mL) | Fasted | 56 | 227.8 | 101.7 | (92.83, 111.5) | 29.0 |
| Fed | 55 | 231.8 | ||||
| AUC∞ (ng h/mL) | Fasted | 54 | 237.5 | 108.9 | (98.48, 120.5) | 28.3 |
| Fed | 44 | 258.7 | ||||
| Cmax (ng/mL) | Fasted | 56 | 133.0 | 78.86 | (68.58, 90.68) | 45.5 |
| Fed | 55 | 104.9 |
| PK parameter | Condition | N | Median | Median difference | 90% CI of median difference (Fed–fasted) | P value |
|---|---|---|---|---|---|---|
| Tmax (h)‡ | Fasted | 56 | 1.0 | 1.0 | (0.75, 1.3) | < 0.001 |
| Fed | 55 | 2.0 |
N patients = the total number of patients for which the PK parameter could be calculated. AUC∞, t1/2, CL/F, and V/F could not be calculated in some instances, if there were not data from a sufficient number of time points after the occurrence of Cmax
Slight differences in geometric means of AUC∞ and Cmax are due to different methods of calculation
AUCt area under the plasma concentration–time curve from time 0 to time t, AUC∞ area under the plasma concentration–time curve from time 0 extrapolated to infinity, Cmax maximum plasma concentration, Tmax time to Cmax, t1/2 terminal half-life, CL/F apparent total clearance, Vz/F volume of distribution, NA not applicable
†Calculated using an analysis of variance (ANOVA) model
‡Median and median difference (Test vs. Reference), and 90% CI of the median difference, are from Hodges-Lehmann estimate. The P value is from Wilcoxon signed-rank test
aCalculated using summary statistics.
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