Table 2.
Dose escalation schema and frequency of dose limiting toxicities
| Dose level | Total n of patients | Selumetinib, oral dose | Cetuximab, IV load/week | N of courses | N of unevaluable patientsa | N of patients with DLTs | DLT description |
|---|---|---|---|---|---|---|---|
| 1 | 7 | 50mg Daily | 400mg/250mg | 16 | 1 | 1 | Hypomagnesemia |
| 2 | 4 | 50mg BID | 400mg/250mg | 12 | 1 | 0 | |
| 3b | 22 | 75mg BID | 400mg/250mg | 34 | 7 | 1c | Acneiform rash |
a
Patients were unevaluable due to not receiving at least 75% scheduled of selumetinib and cetuximab during cycle 1.
b
Includes patients at dose level 3 and the dose expansion cohort
c
This DLT was observed in the KRAS mutant CRC dose expansion cohort.