Table 1. . Full pharmacokinetics schedule.
Cycle # Day # | Time point | N | Comment |
---|---|---|---|
Cycle 1, Day 1 | 0 h ± 15 min (predose) 0.25 h ± 15 min 0.5 h ± 15 min 1 h ± 15 min 2 h ± 15 min 2.5 h ± 15 min 3 h ± 15 min 4 h ± 15 min 8 h ± 15 min 24 h ± 15 min |
24 patients in Arm 1 (CPI-613 + mFFX) |
Pre-infusion Day 2 |
Cycle 1, Day 3 | 0 h ± 15 min (predose) 0.25 h ± 15 min 0.5 h ± 15 min 1 h ± 15 min 2 h ± 15 min 2.5 h ± 15 min 3 h ± 15 min 4 h ± 15 min 8 h ± 15 min 24 h ± 15 min 48 h ± 15 min |
24 patients above | Pre-infusion Day 4 Day 5 |
Cycle 2, Day 1 | 0 h ± 15 min (predose) 0.25 h ± 15 min 0.5 h ± 15 min |
24 patients above | Pre-infusion |
Cycle 2–12, Day 3 | 0 h ± 15 min (predose) 0.25 h ± 15 min 0.5 h ± 15 min |
24 patients above | Pre-infusion |
mFFX: Modified FOLFIRINOX; N: Number.