Table 2. Dose combinations for determination of the MTD.

	Bosutinib, mg per day
Capecitabine, mg m−2 twice daily	200, n	300, n	400, n
1000	4	9a,b	2c
750	4d	4	2c
625	2	5d,e

Abbreviations: DLT=dose-limiting toxicity in patients who experienced a DLT within the first 21 days of treatment, regardless of the number of treatment doses received, or in patients who received ⩾14 doses of bosutinib and ⩾10 days of capecitabine in the first 21 days of treatment; MTD=maximum tolerated dose (shaded in table); n=total number of patients enrolled at each dose combination.

^aBased on the DLTs, the MTD was determined to be bosutinib 300 mg per day plus capecitabine 1000 mg m⁻² (which is shaded in the table). No DLTs were observed at the MTD dose level.

^bTwo patients were initially enrolled at the MTD level, for a total of 24 patients included in the initial DLT evaluation; an additional seven patients were subsequently enrolled at this dose level to allow further evaluation and confirmation of the MTD.

^cDLTs were observed in 1 (50%) patient in the bosutinib 400 mg per day plus capecitabine 1000 mg m⁻² group (grade 3 alanine aminotransferase and pruritus/rash) and 1 (50%) patient in the bosutinib 400 mg per day plus capecitabine 750 mg m⁻² group (grade 3 neurologic pain).

^dInitial dose cohorts investigated.

^eOne of the five patients treated at this dose level was excluded from the DLT evaluation because of no DLT and failure to receive ⩾14 doses of bosutinib or ⩾10 doses of capecitabine.