Table 4.
Summary of plasma PK parameters of PEV in combination with IV/SC AZA: MTD expansion
| MTD expansion | IV cohort (N = 26) | SC cohort (N = 28)* |
|---|---|---|
| Cycle 1, day 1 | ||
| Tmax, h | 1.01 (0.65-2.03) | 1.00 (0.88-3.00) |
| Cmax, ng/mL | 155 (41.2) | 152 (32.3) |
| AUC24, ng/h per mL | 861 (26.7) | 890 (29.3) |
| AUC48, ng/h per mL | 976 (24.6)† | 1000 (23.7)‡ |
| t1/2, h | 7.45 (1.85) | 7.30 (1.76) |
| Cycle 1, day 5 | ||
| Tmax, h | 1.00 (0.92-2.00) | 0.98 (0.83-2.00) |
| Cmax, ng/mL | 164 (41.3) | 148 (40.6) |
| AUC24, ng/h per mL | 921 (23.8) | 926 (25.5) |
| AUC48, ng/h per mL | 1100 (22.5)§ | 1100 (21.4)|| |
| t1/2, h | 8.07 (2.14) | 7.89 (1.76) |
Parameters are presented as geometric mean (% coefficient of variation) unless specified otherwise; Tmax (median and range); t1/2 (mean and standard deviation).
*
One patient is not PK evaluable due to insufficient concentration–time data collected during cycle 1 for analysis.
†
n = 12.
‡
n = 11.
§
n = 13.
||
n = 18.