Table A4.

Dose-Corrected Trough Plasma Concentrations for Sunitinib, SU12662, and Sunitinib plus SU12662 at the MTDs

Schedule/Cycle	No. of Patients	Trough Plasma Concentration (ng/mL)
		Sunitinib		SU12662		Sunitinib + SU12662
		Median	Range	Median	Range	Median	Range
Schedule 4/2
C1 D29	6	35.0	10.9-63.8	11.8	10.1-17.4	46.5	23.0-80.7
C2 D28	4	40.0	0.7-40.5	11.3	1.0-21.4	43.8	1.7-58.9
C3 D28	1	62.9	62.9-62.9	15.7	15.7-15.7	78.6	78.6-78.6
Schedule 2/1
C4 D14	2	31.9	3.4-60.4	9.1	2.6-15.6	41.0	5.9-76.0
C10 D14	1	4.1	4.1-4.1	2.6	2.6-2.6	6.7	6.7-6.7
Continuous daily dosing schedule
C1 D1	17	0	0-5.7	0	0-2.3	0	0-7.9
C2 D1	9	45.3	20.0-81.9	10.1	6.4-45.6	54.6	27.4-125.4
C3 D1	5	29.5	4.8-52.7	10.4	7.9-18.6	37.9	15.2-71.3
C4 D1	4	27.4	1.9-42.7	7.8	1.9-12.3	35.1	3.9-55.0
C5 D1	3	34.1	28.4-66.3	12.1	6.2-20.9	40.4	40.3-87.2

NOTE. Schedule 4/2, 4 weeks on treatment, 2 weeks off treatment; Schedule 2/1, 2 weeks on treatment, 1 week off treatment. Schedule 4/2 maximum-tolerated dose (MTD): sunitinib 37.5 mg + capecitabine 1,000 mg/m². Schedule 2/1 MTD: sunitinib 50 mg + capecitabine 1,000 mg/m². Continuous daily dosing schedule MTD: sunitinib 37.5 mg + capecitabine 1,000 mg/m².

Abbreviations: SU12662, active metabolite of sunitinib; C, cycle; D, day.