Table 2.
Summary of DLTs
| Continuous regorafenib 60 mg plus cetuximab (n = 5) | Continuous regorafenib 100 mg plus cetuximab (n = 6) | Intermittent regorafenib 120 mg plus cetuximab (n = 8) | Intermittent regorafenib 160 mg plus cetuximab (n = 23) | Total (n = 42) | |
|---|---|---|---|---|---|
| Patients evaluable for DLT1, n | 3 | 4 | 7 | 13 | 27 |
| DLT observed, n | 0 | 2 | 1 | 0 | 3 |
| Event details | – | Grade 3 hoarseness; Fatal liver failure | Grade 3 HFSR | – | – |
1
Patients valid for DLT assessment were defined as those who completed Cycle 1 and received at least 80% of the planned doses; includes escalation and expansion cohorts.
Abbreviations: DLT, dose‐limiting toxicity; HFSR, hand–foot skin reaction.