Table 4.
Safingol pharmacokinetic parameters by cohort
| Day 1 | Day 1 | Day 8 | Day 8 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cohort | Safingol (mg/m2) |
Cisplatin (mg/m2) |
N | mean Cmax (µM) |
SD | mean AUC (µM*hr) |
SD | N | mean Cmax (µM) |
SD | mean AUC (µM*hr) |
SD |
| 1 | 60 | 75 | 4 | 1.7 | 0.7 | 11.2 | 4.3 | 4 | 1.6 | 0.6 | 16.5 | 12.9 |
| 2 | 120 | 75 | 3 | 3.4 | 1.8 | 21.2 | 8.4 | 3 | 5.6 | 2.6 | 35.1 | 17.5 |
| 3 | 240 | 75 | 3 | 7.5 | 6.2 | 40.9 | 19.6 | 3 | 8.8 | 3.6 | 54.5 | 13.7 |
| 4 | 240 | 60 | 5 | 7.4 | 3.1 | 56.8 | 17.3 | 5 | 5.8 | 1.3 | 42.8 | 15.8 |
| 5 | 360 | 60 | 3 | 16.1 | 4.8 | 76.0 | 10.4 | 3 | 18.1 | 5.2 | 80.7 | 18.0 |
| 6 | 480 | 60 | 3 | 15.2 | 1.6 | 82.7 | 24.4 | 3 | 15.4 | 3.7 | 94.2 | 18.6 |
| 7 | 600 | 60 | 3 | 23.9 | 9.6 | 105.8 | 49.5 | 2 | 23.3 | 11.9 | 128.3 | 39.8 |
| 8 | 750 | 60 | 6 | 26.8 | 2.9 | 101.9 | 7.7 | 0 | ND | ND | ND | ND |
| 9 | 930 | 60 | 6 | 25.6 | 2.2 | 104.9 | 18.3 | 0 | ND | ND | ND | ND |
| 10 | 840 | 60 | 3 | 23.5 | 6.5 | 109.9 | 16.1 | 0 | ND | ND | ND | ND |
For patients in Cohorts 8–10, samples were only obtained on Day 1, when safingol was given alone.