Table 2.

Dose-escalation and DLT experience

Dose level	EKB-569 Dose (mg/d)	Capecitabine dose (mg/m2/twice daily)	No. of patients	No. of cycles	No. of patients with DLT
1	25	750	6	131	1 with grade 3 diarrhea
2	50	750	7*	42	1 with grade 3 diarrhea, hypotension, and dehydration
3	50	1,000	20	86	1 with grade 3 diarrhea
4	75	1,000	4	6	1 with grade 3 diarrhea
					1 with grade 2 diarrhea and rash
Total			37

^*One patient was removed from the study on cycle 1, day 4 to receive palliative radiation and was not considered evaluable for dose escalation.