To assess the safety and tolerability of sunitinib when administered in combination with modified FOLFOX6 in Japanese patients with metastatic colorectal cancer in the first-line treatment setting.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2)
50 mg/day, oral, administered on an outpatient basis for 2 weeks on, 2 weeks off (Schedule 2/2)
Pfizer Investigational Site
Kashiwa, Chiba, Japan
Pfizer Investigational Site
Suntougun, Shizuoka, Japan
Pfizer Investigational Site
Chuo-ku, Tokyo, Japan
Number of Participants With Adverse Events
Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , serious adverse events, adverse events resulted in discontinuation, treatment interruption, or dose reduction.
Time frame: Up to 733 days (the last subject study discontinuation)
Plasma Concentration of Sunitinib
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.
Time frame: Cycle 1 Day 14 and Cycle 2 Day 1
Plasma Concentration of Sunitinib Active Metabolite (SU012662)
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.
Time frame: Cycle 1 Day 14 and Cycle 2 Day 1
Plasma Concentration of the Total Drug (Sunitinib Plus SU012662)
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.
Time frame: Cycle 1 Day 14 and Cycle 2 Day 1
Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST)
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.
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Time frame: Up to the last subject completed Cycle 24 or individual study discontinuation
Duration of Response (DR)
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.
Time frame: Up to 733 days (the last subject study discontinuation)
Progression-Free Survival (PFS)
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.
Time frame: Up to 733 days (the last subject study discontinuation)
Sunitinib Relative Dose Intensity in the Treatment Arm A
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.
Time frame: Up to 733 days (the last subject study discontinuation in the Treatment Arm A)
Sunitinib Relative Dose Intensity in the Treatment Arm B
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.
Time frame: Up to 384 days (the last subject study discontinuation in the Treatment Arm B)