Table 4.
Parameter | Citarinostat dose, cycle 1 day 1 | Citarinostat dose, cycle 1 day 15 | ||||
---|---|---|---|---|---|---|
180 mg | 360 mg | 480 mg | 180 mg | 360 mg | 480 mg | |
n = 3 | n = 10 | n = 6 | n = 3 | n = 10 | n = 5 b | |
Pharmacokinetics for citarinostat | ||||||
Cmax, mean (SD), ng/mL | 1614 (851) | 3047 (1644) | 3235 (1138) | 3067 (1980) | 3807 (2867) | 2998 (1501) |
Tmax, median (min–max), h | 2.00 (2.00–2.00) | 1.50 (1.00–4.00) | 1.50 (1.00–4.00) | 1.00 (1.00–1.00) | 1.00 (1.00–6.00) | 1.00 (1.00–4.00) |
t1/2, mean (SD), h | 2.8 (0.11) | 2.9 (0.36) | 2.8 (0.26) c | 2.9 (0.11) | 3.3 (0.44) d | 3.4 (0.72) |
AUC0-24h, mean (SD), h•ng/mL | 5812 (2082) | 11,622 (3458) | 13,248 (1324) | 7715 (3738) | 11,526 (4661) | 13,314 (2691) |
AUC0-∞, mean (SD), h•ng/mL | 5820 (2083) | 11,650 (3464) | 13,575 (1220) c | 7725 (3741) | 12,682 (3266) d | 13,430 (2711) |
Pharmacokinetics for paclitaxel | ||||||
Cmax, mean (SD), ng/mL | 4820 (2050) | 2988 (627) | 2355 (578) | 5433 (2331) | 3597 (1199) | 2820 (1172) |
t1/2, mean (SD), h | 9.0 (0.93) | 9.5 (1.3) | 10.8 (2.2) | 9.5 (1.6) | 9.9 (2.3) | 9.8 (4.4) |
AUC0-24h, mean (SD), h•ng/mL | 5986 (1284) | 3837 (594) | 3260 (705) | 7537 (3677) | 4985 (1272) | 3183 (1044) |
AUC0-∞, mean (SD), h•ng/mL | 6612 (1363) | 4354 (696) | 3845 (867) | 8446 (3744) | 5692 (1417) | 3531 (1441) |
AUC, area under the curve; Cmax, maximum concentration; max, maximum; min, minimum; Tmax, time to maximum concentration.
Data cutoff: November 27, 2017.
n = 4 for paclitaxel pharmacokinetics.
n = 5.
n = 9.