Table 2. Patient dosing and DLT assessment.

Pre-amendment at original planned dose of I; cycle = 6 weeks*
Dose cohort	Irinotecan (mg/m2 on d1,8,15,22)	Sorafenib (mg)	Cetuximab (mg/m2 weekly)**	N	Median no of completed cycles (range)	DLT
1	120	200 QD	400 LD/ 250MD	4	2 (1-3)	2
-1	120	200 QOD	400 LD/ 250MD	1	2 (2)	0
Post-amendment at reduced dose of I; cycle = 3 weeks*
Dose cohort	Irinotecan (mg/m2 on d1,8)	Sorafenib (mg)	Cetuximab (mg/m2 weekly)	N	Median no of completed cycles (range)	DLT
1A	100	200 QD	400 LD/ 250MD	3	2 (1-2)	0
2	100	200 BID	400 LD/ 250MD	3	1-14	0
3***	100	400 BID	400 LD/ 250MD	7	1,4 (1-12)	0

^*1^st cycle with an additional 2 week lead-in with S, C only

^**LD = Loading Dose; MD = Maintenance Dose

^***Recommended Phase II Dose