50 mg/day, oral, administered on an outpatient basis for 2 weeks on, 2 weeks off (Schedule 2/2)

Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.

Complete response (CR): 2 or more sequential occasions of documented objective disappearance of all target lesions at a minimum of 4 weeks apart; partial response (PR): 2 or more occasions of >=30% decrease in the sum of the longest diameter (LD) of the target lesions from baseline at a minimum of 4 weeks apart; stable disease (SD): at least 1 objective status of stable/no response at least 6 weeks after enrollment; progressive disease (PD): Objective status of progression within 12 weeks of enrollment, not qualifying as CR, PR or Stable; Indeterminate: no other response category applies.

Duration of response is defined as the duration from the date of first documentation of complete response (CR) or partial response (PR) to date of first documentation of objective progression based on the investigator's assessment.

Progression-free survival is defined as the time from date of enrolment to date of first documentation of progression based on investigator's assessment or death due to any cause.

Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 3; Period 2: Cycle 4 to 6; Period"n": Cycle (n-1)*3+1 to n*3.

Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 2; Period 2: Cycle 3 to 4, Period"n": Cycle (n-1)*2+1 to n*2.

Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).

FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.

Total of all reporting groups

Score 0: Fully active, able to carry on all pre-disease performance without restriction; Score

1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, such as light house work and office work.

Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2). FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.

Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.

Pharmacokinetic analysis population consisted of subjects with at least 1 plasma drug concentration measurement in the Treatment Arm B.

Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.

Pharmacokinetic analysis population consisted of subjects with at least 1 plasma drug concentration measurement in the Treatment Arm B.

Concentrations after administration of sunitinib alone (Day 14 of Cycle 1) and those after administration of sunitinib in combination with mFOLFOX6 (Day 1 of Cycle 2) were evaluated.

Pharmacokinetic analysis population consisted of subjects with at least 1 plasma drug concentration measurement in the Treatment Arm B.

Complete response (CR): 2 or more sequential occasions of documented objective disappearance of all target lesions at a minimum of 4 weeks apart; partial response (PR): 2 or more occasions of >=30% decrease in the sum of the longest diameter (LD) of the target lesions from baseline at a minimum of 4 weeks apart; stable disease (SD): at least 1 objective status of stable/no response at least 6 weeks after enrollment; progressive disease (PD): Objective status of progression within 12 weeks of enrollment, not qualifying as CR, PR or Stable; Indeterminate: no other response category applies.

All enrolled subjects who 1) had a diagnosis of locally-advanced or metastatic adenocarcinoma of the colon or rectum with measurable disease at baseline; 2) had received at least one dose of the investigational product; and 3) with efficacy data available after administration of the investigational product.

Duration of response is defined as the duration from the date of first documentation of complete response (CR) or partial response (PR) to date of first documentation of objective progression based on the investigator's assessment.

Summary statistics were not calculated due to a small number of subjects.

Progression-free survival is defined as the time from date of enrolment to date of first documentation of progression based on investigator's assessment or death due to any cause.

Summary statistics were not calculated due to a small number of subjects.

Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 3; Period 2: Cycle 4 to 6; Period"n": Cycle (n-1)*3+1 to n*3.

All subjects who received at least 1 dose of the study drug. n = number of subjects assessed for relative dose intensity in the given period.

Relative dose intensity is defined as percentage of total dose administered over total dose assigned through assessment period. Period 1: Cycle 1 to 2; Period 2: Cycle 3 to 4, Period"n": Cycle (n-1)*2+1 to n*2.

All subjects who received at least 1 dose of the study drug. n = number of subjects assessed for relative dose intensity in the given period.

Sunitinib was administered orally in a 2 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 50 mg/day (50 mg/day in Schedule 2/2).

FOLFOX was administered on an every-2-week cycle using the mFOLFOX6 regimen consisting of oxaliplatin 85 mg/meter^2 and l-leucovorin 200 mg/meter^2 as a 2-hour intravenous infusion followed by an intravenous bolus of fluorouracil 400 mg/meter^2 and a 46-hour intravenous infusion of fluorouracil 2,400 mg/meter^2 on Days 1 and 2 of each cycle.