Table 3.
Summary of plasma PK parameters of PEV in combination with IV/SC AZA: dose escalation
| 20-mg/m2 IV cohort (n = 6) | 30-mg/m2 SC cohort (n = 3) | |
|---|---|---|
| Cycle 1, day 1 | ||
| Tmax, h | 1.06 (0.97-2.27) | 0.98 (0.97-1.00) |
| Cmax, ng/mL | 158 (51.4) | 299 (29.9) |
| AUC24, ng/h per mL | 990 (28.0) | 1640 (26.4) |
| AUC48, ng/h per mL | 1110 (30.6) | 1770 (25.8) |
| t1/2, h | 7.80 (1.13) | 7.39 (0.699) |
| Cycle 1, day 5 | ||
| Tmax, h | 0.99 (0.97-1.48) | —* |
| Cmax, ng/mL | 165 (48.4) | — |
| AUC24, ng/h per mL | 986 (38.4) | — |
| AUC48, ng/h per mL | 1090 (35.6) | — |
| t1/2, h | 7.98 (0.818) | — |
All patients on the dose-escalation cohorts received IV PEV (20 mg/m2 cohort, n = 6; 30 mg/m2 cohort, n = 3). Parameters are presented as geometric mean (% coefficient of variation) unless specified otherwise; Tmax (median and range); t1/2 (mean and standard deviation).
*
Not reported; only 1 patient was evaluable on cycle 1, day 5, as dosing was halted due to AEs.