Table 4. Summary by dose level (N=31).
| Dose Level (foretinib/erlotinib in mg) |
N | Inevaluable for DLT | DLT | Action taken |
|---|---|---|---|---|
| DL1 (30/100) | 4 | 1 | None | Open DL1 |
| DL2 (30/150) | 8 | 1 | 1 gr 3 rash with dose delay, reduction | DL2 expanded, then open DL3 |
| DL3 (45/150) | 4 | 0 | None | DL3 expanded for suspected PK interaction |
| DL3 expansion cohort | 3 | 0 | None | DL2, DL1 expanded for unconfirmed PK interaction |
| DL2 expansion cohort (30/150) | 7 | 3 | 1 gr 3 mucositis, neck pain (delay, dose reduction, admission) 1 gr 3 fatigue, nausea (delay) |
DL2 declared RP2D |
| DL1 expansion cohort (30/100) | 5 | 1 | None |
DL: dose level; gr: grade; PK: pharmacokinetic; RP2D: recommended phase 2 dose.