Table A4.
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.