Trial Outcomes & Findings for Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer (NCT NCT00631410)

Last Updated: 2011-03-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

12 participants

Primary outcome timeframe

Up to 733 days (the last subject study discontinuation)

Results posted on

2011-03-16

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Arm A 37.5 mg/Day (4/2) Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). A combination chemotherapy of fluorouracil, calcium folinate and oxaliplatin (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.	Treatment Arm B 50 mg/Day (2/2) 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). A combination chemotherapy of fluorouracil, calcium folinate and oxaliplatin (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.
Overall Study STARTED	6	6
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	6	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Arm A 37.5 mg/Day (4/2) Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). A combination chemotherapy of fluorouracil, calcium folinate and oxaliplatin (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.	Treatment Arm B 50 mg/Day (2/2) 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). A combination chemotherapy of fluorouracil, calcium folinate and oxaliplatin (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.
Overall Study Adverse Event	1	3
Overall Study Objective Progression or Relapse	4	3
Overall Study Surgery	1	0

Baseline Characteristics

Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Arm A 37.5 mg/Day (4/2) n=6 Participants Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). 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.	Treatment Arm B 50 mg/Day (2/2) n=6 Participants 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 n=12 Participants Total of all reporting groups
Age, Customized 20-44 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants
Age, Customized 45-64 years	4 participants n=5 Participants	3 participants n=7 Participants	7 participants n=5 Participants
Age, Customized >=65 years	2 participants n=5 Participants	3 participants n=7 Participants	5 participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status Score 1	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 733 days (the last subject study discontinuation)

Population: All subjects who received at least 1 dose of the study drug.

Outcome measures

Outcome measures
Measure	Treatment Arm A 37.5 mg/Day (4/2) n=6 Participants Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). 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.	Treatment Arm B 50 mg/Day (2/2) n=6 Participants 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.
Number of Participants With Adverse Events Any adverse events	6 participants	6 participants
Number of Participants With Adverse Events Any serious adverse evets	2 participants	4 participants
Number of Participants With Adverse Events Any Grade-3 or -4 adverse evets	6 participants	6 participants
Number of Participants With Adverse Events Any Grade-5 adverse events (= death)	0 participants	0 participants
Number of Participants With Adverse Events Discontinuation due to adverse events	1 participants	3 participants
Number of Participants With Adverse Events Sunitinib interruption due to adverse events	6 participants	6 participants
Number of Participants With Adverse Events mFOLFOX6 interruption due to adverse events	6 participants	6 participants
Number of Participants With Adverse Events Sunitinib dose reduction due to adverse events	1 participants	1 participants
Number of Participants With Adverse Events mFOLFOX6 dose reduction due to adverse events	2 participants	4 participants

SECONDARY outcome

Timeframe: Cycle 1 Day 14 and Cycle 2 Day 1

Population: 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.

Outcome measures

Outcome measures
Measure	Treatment Arm A 37.5 mg/Day (4/2) n=4 Participants Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). 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.	Treatment Arm B 50 mg/Day (2/2) 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.
Plasma Concentration of Sunitinib Cycle 1 Day 14, 0 hour post dose	85.40 nanogram per milliliter Interval 59.7 to 102.0	—
Plasma Concentration of Sunitinib Cycle 1 Day 14, 2 hour post dose	86.15 nanogram per milliliter Interval 66.7 to 107.0	—
Plasma Concentration of Sunitinib Cycle 1 Day 14, 6 hour post dose	93.35 nanogram per milliliter Interval 86.8 to 101.0	—
Plasma Concentration of Sunitinib Cycle 1 Day 14, 8 hour post dose	98.50 nanogram per milliliter Interval 83.8 to 107.0	—
Plasma Concentration of Sunitinib Cycle 2 Day 1, 0 hour post dose	81.70 nanogram per milliliter Interval 71.3 to 97.9	—
Plasma Concentration of Sunitinib Cycle 2 Day 1, 2 hour post dose	87.05 nanogram per milliliter Interval 81.3 to 90.9	—
Plasma Concentration of Sunitinib Cycle 2 Day 1, 6 hour post dose	109.50 nanogram per milliliter Interval 102.0 to 115.0	—
Plasma Concentration of Sunitinib Cycle 2 Day 1, 8 hour post dose	102.00 nanogram per milliliter Interval 92.8 to 116.0	—
Plasma Concentration of Sunitinib Cycle 2 Day 1, 24 hour post dose	81.50 nanogram per milliliter Interval 79.3 to 96.1	—

SECONDARY outcome

Timeframe: Cycle 1 Day 14 and Cycle 2 Day 1

Population: 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.

Outcome measures

Outcome measures
Measure	Treatment Arm A 37.5 mg/Day (4/2) n=4 Participants Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). 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.	Treatment Arm B 50 mg/Day (2/2) 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.
Plasma Concentration of Sunitinib Active Metabolite (SU012662) Cycle 1 Day 14, 0 hour post dose	41.75 nanogram per milliliter Interval 16.1 to 59.2	—
Plasma Concentration of Sunitinib Active Metabolite (SU012662) Cycle 1 Day 14, 2 hour post dose	36.90 nanogram per milliliter Interval 18.4 to 68.5	—
Plasma Concentration of Sunitinib Active Metabolite (SU012662) Cycle 1 Day 14, 6 hour post dose	43.55 nanogram per milliliter Interval 19.8 to 58.9	—
Plasma Concentration of Sunitinib Active Metabolite (SU012662) Cycle 1 Day 14, 8 hour post dose	42.35 nanogram per milliliter Interval 18.8 to 64.9	—
Plasma Concentration of Sunitinib Active Metabolite (SU012662) Cycle 2 Day 1, 0 hour post dose	42.65 nanogram per milliliter Interval 19.6 to 62.4	—
Plasma Concentration of Sunitinib Active Metabolite (SU012662) Cycle 2 Day 1, 2 hour post dose	36.10 nanogram per milliliter Interval 23.4 to 61.2	—
Plasma Concentration of Sunitinib Active Metabolite (SU012662) Cycle 2 Day 1, 6 hour post dose	46.95 nanogram per milliliter Interval 23.4 to 67.0	—
Plasma Concentration of Sunitinib Active Metabolite (SU012662) Cycle 2 Day 1, 8 hour post dose	47.10 nanogram per milliliter Interval 25.7 to 70.1	—
Plasma Concentration of Sunitinib Active Metabolite (SU012662) Cycle 2 Day 1, 24 hour post dose	44.85 nanogram per milliliter Interval 21.7 to 60.5	—

SECONDARY outcome

Timeframe: Cycle 1 Day 14 and Cycle 2 Day 1

Population: 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.

Outcome measures

Outcome measures
Measure	Treatment Arm A 37.5 mg/Day (4/2) n=4 Participants Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). 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.	Treatment Arm B 50 mg/Day (2/2) 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.
Plasma Concentration of the Total Drug (Sunitinib Plus SU012662) Cycle 2 Day 1, 24 hour post dose	132.15 nanogram per milliliter Interval 101.7 to 144.3	—
Plasma Concentration of the Total Drug (Sunitinib Plus SU012662) Cycle 1 Day 14, 0 hour post dose	136.25 nanogram per milliliter Interval 75.8 to 143.0	—
Plasma Concentration of the Total Drug (Sunitinib Plus SU012662) Cycle 1 Day 14, 2 hour post dose	123.05 nanogram per milliliter Interval 85.1 to 175.5	—
Plasma Concentration of the Total Drug (Sunitinib Plus SU012662) Cycle 1 Day 14, 6 hour post dose	136.75 nanogram per milliliter Interval 106.9 to 159.9	—
Plasma Concentration of the Total Drug (Sunitinib Plus SU012662) Cycle 1 Day 14, 8 hour post dose	142.35 nanogram per milliliter Interval 102.6 to 168.9	—
Plasma Concentration of the Total Drug (Sunitinib Plus SU012662) Cycle 2 Day 1, 0 hour post dose	132.85 nanogram per milliliter Interval 90.9 to 143.3	—
Plasma Concentration of the Total Drug (Sunitinib Plus SU012662) Cycle 2 Day 1, 2 hour post dose	122.15 nanogram per milliliter Interval 114.3 to 144.5	—
Plasma Concentration of the Total Drug (Sunitinib Plus SU012662) Cycle 2 Day 1, 6 hour post dose	155.45 nanogram per milliliter Interval 133.4 to 176.0	—
Plasma Concentration of the Total Drug (Sunitinib Plus SU012662) Cycle 2 Day 1, 8 hour post dose	156.60 nanogram per milliliter Interval 118.5 to 171.1	—

SECONDARY outcome

Timeframe: Up to the last subject completed Cycle 24 or individual study discontinuation

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Treatment Arm A 37.5 mg/Day (4/2) n=6 Participants Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). 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.	Treatment Arm B 50 mg/Day (2/2) n=6 Participants 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.
Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) Complete Response (CR)	0 participants	0 participants
Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) Partial Response (PR)	4 participants	4 participants
Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) Stable Disease (SD)	1 participants	1 participants
Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) Progressive Disease (PD)	1 participants	0 participants
Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) Indeterminate	0 participants	1 participants
Best Overall Response Based on Response Evaluation Criteria in Solid Tumors (RECIST) Objective Response (CR+PR)	4 participants	4 participants

SECONDARY outcome

Timeframe: Up to 733 days (the last subject study discontinuation)

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

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 733 days (the last subject study discontinuation)

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 733 days (the last subject study discontinuation in the Treatment Arm A)

Population: 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 3; Period 2: Cycle 4 to 6; Period"n": Cycle (n-1)\*3+1 to n\*3.

Outcome measures

Outcome measures
Measure	Treatment Arm A 37.5 mg/Day (4/2) n=6 Participants Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). 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.	Treatment Arm B 50 mg/Day (2/2) 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.
Sunitinib Relative Dose Intensity in the Treatment Arm A Period 1 (n=6)	57.1 percent of total planned dose Standard Deviation 9.3	—
Sunitinib Relative Dose Intensity in the Treatment Arm A Period 2 (n=5)	72.4 percent of total planned dose Standard Deviation 18.5	—
Sunitinib Relative Dose Intensity in the Treatment Arm A Period 3 (n=5)	64.3 percent of total planned dose Standard Deviation 21.1	—
Sunitinib Relative Dose Intensity in the Treatment Arm A Period 4 (n=4)	53.6 percent of total planned dose Standard Deviation 15.4	—
Sunitinib Relative Dose Intensity in the Treatment Arm A Period 5 (n=3)	42.9 percent of total planned dose Standard Deviation 16.5	—
Sunitinib Relative Dose Intensity in the Treatment Arm A Period 6 (n=2)	50.0 percent of total planned dose Standard Deviation 0.0	—
Sunitinib Relative Dose Intensity in the Treatment Arm A Period 7 (n=2)	40.5 percent of total planned dose Standard Deviation 37.0	—
Sunitinib Relative Dose Intensity in the Treatment Arm A Period 8 (n=1)	50.0 percent of total planned dose Standard Deviation 0	—
Sunitinib Relative Dose Intensity in the Treatment Arm A Period 9 (n=1)	50.0 percent of total planned dose Standard Deviation 0	—
Sunitinib Relative Dose Intensity in the Treatment Arm A Period 10 (n=1)	23.8 percent of total planned dose Standard Deviation 0	—
Sunitinib Relative Dose Intensity in the Treatment Arm A Period 11 (n=1)	33.3 percent of total planned dose Standard Deviation 0	—
Sunitinib Relative Dose Intensity in the Treatment Arm A Period 12 (n=1)	23.8 percent of total planned dose Standard Deviation 0	—
Sunitinib Relative Dose Intensity in the Treatment Arm A Period 13 (n=1)	25.0 percent of total planned dose Standard Deviation 0	—
Sunitinib Relative Dose Intensity in the Treatment Arm A Period 14 (n=1)	33.3 percent of total planned dose Standard Deviation 0	—
Sunitinib Relative Dose Intensity in the Treatment Arm A Period 15 (n=1)	23.8 percent of total planned dose Standard Deviation 0	—
Sunitinib Relative Dose Intensity in the Treatment Arm A Period 16 (n=1)	25.0 percent of total planned dose Standard Deviation 0	—

SECONDARY outcome

Timeframe: Up to 384 days (the last subject study discontinuation in the Treatment Arm B)

Population: 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.

Outcome measures

Outcome measures
Measure	Treatment Arm A 37.5 mg/Day (4/2) n=6 Participants Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). 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.	Treatment Arm B 50 mg/Day (2/2) 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.
Sunitinib Relative Dose Intensity in the Treatment Arm B Period 1 (n=6)	100.0 percent of total planned dose Standard Deviation 0	—
Sunitinib Relative Dose Intensity in the Treatment Arm B Period 2 (n=5)	97.1 percent of total planned dose Standard Deviation 3.9	—
Sunitinib Relative Dose Intensity in the Treatment Arm B Period 3 (n=5)	78.6 percent of total planned dose Standard Deviation 23.6	—
Sunitinib Relative Dose Intensity in the Treatment Arm B Period 4 (n=5)	90.0 percent of total planned dose Standard Deviation 13.7	—
Sunitinib Relative Dose Intensity in the Treatment Arm B Period 5 (n=5)	82.1 percent of total planned dose Standard Deviation 11.0	—
Sunitinib Relative Dose Intensity in the Treatment Arm B Period 6 (n=3)	73.8 percent of total planned dose Standard Deviation 26.8	—
Sunitinib Relative Dose Intensity in the Treatment Arm B Period 7 (n=3)	75.0 percent of total planned dose Standard Deviation 25.0	—
Sunitinib Relative Dose Intensity in the Treatment Arm B Period 8 (n=3)	75.0 percent of total planned dose Standard Deviation 25.0	—
Sunitinib Relative Dose Intensity in the Treatment Arm B Period 9 (n=3)	73.8 percent of total planned dose Standard Deviation 26.8	—
Sunitinib Relative Dose Intensity in the Treatment Arm B Period 10 (n=3)	73.8 percent of total planned dose Standard Deviation 26.8	—
Sunitinib Relative Dose Intensity in the Treatment Arm B Period 11 (n=1)	100.0 percent of total planned dose Standard Deviation 0	—
Sunitinib Relative Dose Intensity in the Treatment Arm B Period 12 (n=1)	35.7 percent of total planned dose Standard Deviation 0	—

Adverse Events

Treatment Arm A 37.5 mg/Day (4/2)

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Treatment Arm B 50 mg/Day (2/2)

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Arm A 37.5 mg/Day (4/2) n=6 participants at risk Sunitinib was administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen, at a starting dose of 37.5 mg/day (37.5 mg/day in Schedule 4/2). 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.	Treatment Arm B 50 mg/Day (2/2) n=6 participants at risk 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.
Gastrointestinal disorders Nausea	0.00% 0/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Oesophagitis	0.00% 0/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	0.00% 0/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Fatigue	16.7% 1/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Neutrophil count decreased	0.00% 0/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations Platelet count decreased	0.00% 0/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Investigations White blood cell count decreased	0.00% 0/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Anorexia	16.7% 1/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	33.3% 2/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	16.7% 1/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Cerebral infarction	0.00% 0/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	16.7% 1/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Hiccups	16.7% 1/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/6 • Up to 733 days (the last subject study discontinuation) The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER