Table III.

Overview of Dose Levels and Dose-Limiting Toxicities (DLTs)*

Dose level	Capecitabine (mg/m2) at 9:00 h / 24:00 h	Number of patients	Patients experiencing DLT
1	375 / 625	3	None
2	475 / 800	3	None
3	600 / 1000	3	None
4	750 / 1250	8	None
5	950 / 1600	5	2

*DLT was defined as any of the following events occurring in the first 3 weeks of treatment considered to be at least possibly, probably or definitely related to study treatment: ≥ grade 3 non-hematologic toxicity (other than alopecia, inadequately treated nausea, vomiting or diarrhoea), thrombocytopenia grade 4 or grade 3 associated with bleeding events, grade 4 neutropenia, grade 3 febrile neutropenia, ≥ grade 3 anaemia, and/or a dose interruption of more than 7 days due to toxicity

§ A total of 22 patients out of the 25 enrolled were evaluable for safety. One patient in dose level 5 was not evaluable for DLT, due intake of an incorrect capecitabine dose during the first 7 days of treatment. Two patients only received one treatment cycle due to symptomatic deterioration related to quick disease progression