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Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors

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ClinicalTrials.gov Identifier: NCT00599924
Recruitment Status : Completed
First Posted : January 24, 2008
Results First Posted : December 9, 2009
Last Update Posted : July 15, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Colorectal Neoplasms
Neoplasms
Intervention Drug: sunitinib + FOLFOX
Enrollment 53
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2) 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) 37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing) 25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Hide Arm/Group Description Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6. CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6. Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6 Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6 Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6. Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
Period Title: Overall Study
Started 4 9 5 12 9 6 8
Completed 1 4 3 4 3 2 3
Not Completed 3 5 2 8 6 4 5
Reason Not Completed
Lack of Efficacy             3             5             1             2             3             2             0
Adverse Event             0             0             0             2             0             0             2
Death             0             0             0             2             0             2             1
Protocol Violation             0             0             0             1             0             0             0
Withdrawal by Subject             0             0             1             0             1             0             0
Other             0             0             0             1             2             0             2
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2) 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) 37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing) 25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing) Total
Hide Arm/Group Description Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6. CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6. Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6 Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6 Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6. Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6. Total of all reporting groups
Overall Number of Baseline Participants 4 9 5 12 9 6 8 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 4 participants 9 participants 5 participants 12 participants 9 participants 6 participants 8 participants 53 participants
< 65 years 2 6 5 7 6 6 5 37
> = 65 years 2 3 0 5 3 0 3 16
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 9 participants 5 participants 12 participants 9 participants 6 participants 8 participants 53 participants
Female
1
  25.0%
4
  44.4%
2
  40.0%
6
  50.0%
1
  11.1%
2
  33.3%
3
  37.5%
19
  35.8%
Male
3
  75.0%
5
  55.6%
3
  60.0%
6
  50.0%
8
  88.9%
4
  66.7%
5
  62.5%
34
  64.2%
1.Primary Outcome
Title Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.
Time Frame up to 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) = all subjects enrolled in the study that received at least one dose of study medication. Subjects who did not complete the follow-up period for dose limiting toxicity assessment because of death from progressive disease or other non-treatment related events were replaced.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2) 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) 37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing) 25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
Overall Number of Participants Analyzed 4 9 5 12 9 6 8
Measure Type: Number
Unit of Measure: participants
AEs 4 9 5 12 9 6 8
SAEs 0 4 0 7 3 2 4
2.Secondary Outcome
Title Objective Response (OR)
Hide Description From the start of treatment until disease progression/recurrence. OR=confirmed Complete Response (CR) or confirmed Partial Response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR = disappearance of all target lesions. CR was confirmed if it persisted on repeat imaging study ≥ 4 weeks after initial documentation of response. PR = ≥ 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. PR was confirmed if it persisted on repeat imaging study ≥ 4 weeks after initial documentation of response.
Time Frame From start of treatment until Day 8 of Cycles 4 and 8 (2/2 Schedule), Day 8 of Cycles 3 and 6 (4/2 Schedule), and Day 1 of Cycles 3 and 7 (Continuous Dosing)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2) 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) 37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing) 25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
Overall Number of Participants Analyzed 4 9 5 12 9 6 8
Measure Type: Number
Unit of Measure: participants
0 2 0 0 0 0 2
3.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of Sunitinib
Hide Description [Not Specified]
Time Frame pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population of subjects who had completed pharmacokinetic (PK) blood sampling for at least one day.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 4 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1, Day 14 47.13  (13.165) 61.36  (14.692)
Cycle 2, Day 1 44.95  (14.272) 60.24  (13.830)
4.Secondary Outcome
Title Time to Cmax (Tmax) of Sunitinib
Hide Description [Not Specified]
Time Frame pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population of subjects who had completed PK blood sampling for at least one day.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 4 8
Median (Full Range)
Unit of Measure: hours
Cycle 1, Day 14
8.00
(6.00 to 10.00)
10.00
(4.00 to 10.00)
Cycle 2, Day 1
7.00
(6.00 to 24.00)
8.00
(4.00 to 10.00)
5.Secondary Outcome
Title Minimum Plasma Concentration (Cmin) of Sunitinib
Hide Description [Not Specified]
Time Frame pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population of subjects who had completed PK blood sampling for at least one day.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 4 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1, Day 14 34.95  (10.618) 38.23  (11.629)
Cycle 2, Day 1 30.28  (10.188) 39.47  (16.632)
6.Secondary Outcome
Title Clearance (CL/F) of Sunitinib
Hide Description Drug clearance (CL/F) = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.
Time Frame pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population of subjects who had completed PK blood sampling for at least one day.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 4 8
Mean (Standard Deviation)
Unit of Measure: L/hr
Cycle 1, Day 14 41.13  (10.104) 44.29  (5.663)
Cycle 2, Day 1 42.40  (12.700) 49.44  (16.211)
7.Secondary Outcome
Title Area Under Plasma Concentration-Time Profile From Time Zero to Twenty-Four Hours Postdose (AUC24) of Sunitinib
Hide Description AUC24 = Area under the plasma concentration-time profile from time zero (pre-dose) to twenty-four hours. AUC24 was obtained by the Linear/Log trapezoidal method.
Time Frame pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population of subjects who had completed PK blood sampling for at least one day.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 4 8
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
Cycle 1, Day 14 985.43  (251.046) 1233.73  (322.353)
Cycle 2, Day 1 948.40  (284.871) 1202.50  (396.337)
8.Secondary Outcome
Title Terminal Phase Half-Life (t1/2) of Sunitinib
Hide Description t1/2 = terminal phase half-life. t1/2 was obtained by natural log of 2 (ln2) divided by the rate constant for terminal phase (kel).
Time Frame pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
T1/2 for sunitinib was not calculated due to short observation time.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Cmax of SU-012662 (Sunitinib's Metabolite)
Hide Description [Not Specified]
Time Frame pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population of subjects who had completed PK blood sampling for at least one day.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 4 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1, Day 14 18.95  (3.007) 22.80  (5.189)
Cycle 2, Day 1 18.75  (2.977) 23.44  (7.094)
10.Secondary Outcome
Title Tmax of SU-012662 (Sunitinib's Metabolite)
Hide Description [Not Specified]
Time Frame pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population of subjects who had completed PK blood sampling for at least one day.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 4 8
Median (Full Range)
Unit of Measure: hours
Cycle 1, Day 14
8.00
(6.00 to 10.00)
10.00
(0.00 to 24.00)
Cycle 2, Day 1
15.00
(0.00 to 24.00)
4.00
(2.00 to 24.00)
11.Secondary Outcome
Title Cmin of SU-012662 (Sunitinib's Metabolite)
Hide Description [Not Specified]
Time Frame pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 4 8
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1, Day 14 14.45  (3.497) 15.70  (4.365)
Cycle 2, Day 1 13.59  (4.585) 17.68  (5.599)
12.Secondary Outcome
Title AUC24 for SU-012662 (Sunitinib's Metabolite)
Hide Description AUC24 = Area under the plasma concentration-time profile from time zero (pre-dose) to twenty-four hours. AUC24 was obtained by the Linear/Log trapezoidal method.
Time Frame pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population of subjects who had completed PK blood sampling for at least one day.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 4 8
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
Cycle 1, Day 14 401.51  (63.164) 468.79  (117.108)
Cycle 2, Day 1 395.82  (66.618) 495.97  (154.314)
13.Secondary Outcome
Title CL/F of SU-012662 (Sunitinib's Metabolite)
Hide Description CL/F = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.
Time Frame pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
CL/F was not calculated for SU-012662.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title T1/2 of SU-012662 (Sunitinib's Metabolite)
Hide Description t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel.
Time Frame pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
T1/2 for SU-012662 was not calculated due to short observation time.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Cmax of Free Platinum
Hide Description Oxaliplatin was metabolized to platinum and free platinum was measured.
Time Frame pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population of subjects who had completed PK blood sampling for at least one day.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 4 11
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1, Day 1 935.25  (442.974) 634.00  (134.050)
Cycle 2, Day 1 1043.75  (381.656) 789.43  (239.650)
16.Secondary Outcome
Title Tmax of Free Platinum
Hide Description Oxaliplatin was metabolized to platinum and free platinum was measured.
Time Frame pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population of subjects who had completed PK blood sampling for at least one day.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 4 11
Median (Full Range)
Unit of Measure: hours
Cycle 1, Day 1
2.00
(1.00 to 2.00)
2.00
(1.00 to 2.00)
Cycle 2, Day 1
2.00
(2.00 to 2.00)
2.00
(1.00 to 2.00)
17.Secondary Outcome
Title Area Under the Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) for Free Platinum
Hide Description Oxaliplatin was metabolized to platinum and free platinum was measured. AUCinf = Area under the plasma concentration-time profile from time zero (pre-dose) to infinity. AUCinf was obtained by the Linear/Log trapezoidal method.
Time Frame pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population of subjects who had completed PK blood sampling for at least one day.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 4 11
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
Cycle 1, Day 1 7459.28  (2892.442) 6490.17  (1947.621)
Cycle 2, Day 1 7942.64  (3043.567) 7092.65  (1906.756)
18.Secondary Outcome
Title T1/2 for Free Platinum
Hide Description t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel. Oxaliplatin was metabolized to platinum and free platinum was measured.
Time Frame pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population of subjects who had completed PK blood sampling for at least one day.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 4 11
Mean (Standard Deviation)
Unit of Measure: hours
Cycle 1, Day 1 16.15  (3.077) 15.60  (2.038)
Cycle 2, Day 1 18.55  (5.622) 31.20  (37.925)
19.Secondary Outcome
Title Cmax of Total Platinum
Hide Description Oxaliplatin was metabolized to platinum and total platinum was measured.
Time Frame pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population of subjects who had completed PK blood sampling for at least one day.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 4 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1, Day 1 2490.00  (748.465) 2137.14  (415.681)
Cycle 2, Day 1 2905.00  (636.684) 2641.43  (387.145)
20.Secondary Outcome
Title Tmax of Total Platinum
Hide Description Oxaliplatin was metabolized to platinum and total platinum was measured.
Time Frame pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population of subjects who had completed PK blood sampling for at least one day.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 4 12
Median (Full Range)
Unit of Measure: hours
Cycle 1, Day 1
2.00
(2.00 to 2.00)
2.00
(1.00 to 2.00)
Cycle 2, Day 1
2.00
(2.00 to 2.00)
2.00
(2.00 to 2.00)
21.Secondary Outcome
Title Area Under the Plasma Concentration-Time Profile From Time Zero to Forty-Eight Hours (AUC48) for Total Platinum
Hide Description Oxaliplatin was metabolized to platinum and total platinum was measured. AUC48 = Area under the plasma concentration-time profile from time zero (pre-dose) to forty-eight hours. AUC48 was obtained by the Linear/Log trapezoidal method.
Time Frame pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population of subjects who had completed PK blood sampling for at least one day.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 4 12
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
Cycle 1, Day 1 47264.02  (10509.556) 43713.95  (5590.750)
Cycle 2, Day 1 56813.62  (11980.029) 51962.03  (8118.343)
22.Secondary Outcome
Title Steady State Concentration (Css) of Fluorouracil (5-FU)
Hide Description Steady state is reached when the amount of drug getting into the system per unit time is equal to the amount of drug cleared from the system.
Time Frame pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population of subjects who had completed PK blood sampling for at least one day.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 4 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1, Day 1 567.52  (351.207) 334.26  (89.579)
Cycle 2, Day 1 598.86  (127.635) 647.32  (284.203)
23.Secondary Outcome
Title Steady State Clearance (CLss) of 5-FU
Hide Description CLss was determined by total amount of drug received during infusion or duration of infusion (Ki) divided by Css.
Time Frame pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population of subjects who had completed PK blood sampling for at least one day.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 4 12
Mean (Standard Deviation)
Unit of Measure: L/hr
Cycle 1, Day 1 284.99  (147.808) 312.63  (93.563)
Cycle 2, Day 1 174.51  (49.445) 201.12  (103.534)
24.Secondary Outcome
Title Area Under the Curve (AUC) of 5-FU
Hide Description [Not Specified]
Time Frame pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
AUC for 5-FU was not calculated.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
25.Secondary Outcome
Title Cmax of 5-FU
Hide Description [Not Specified]
Time Frame pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Cmax of 5-FU was not calculated.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
26.Secondary Outcome
Title T1/2 of Free Platinum, Total Platinum, and 5-FU
Hide Description t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel. Oxaliplatin was metabolized to platinum and free and total platinum were measured.
Time Frame pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
T1/2 was not calculated for Free Platinum, Total Platinum, and 5-FU.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
27.Secondary Outcome
Title CL/F of Free Platinum, Total Platinum, and 5-FU
Hide Description CL/F = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.
Time Frame pre-dose, 1h, 2h, 2 h 5 min, 2h 15 min, 2h 30 min, 2h 45 min, 4h, 6h, 8h, 10h, 24h, and 48h post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
CL/F was not calculated for Free Platinum, Total Platinum, and 5-FU.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
28.Secondary Outcome
Title Cmin of Free Platinum, Total Platinum, and 5-FU
Hide Description [Not Specified]
Time Frame pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Cmin was not calculated for Free Platinum, Total Platinum, and 5-FU.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
29.Secondary Outcome
Title Volume Endothelial Transfer Constant (Ktrans) of Tumors in a Selected Group of Subjects Assessed by Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI)
Hide Description Volume endothelial Ktrans was estimated by fitting the tissue contrast agent time course to the Kety equation (Tofts model for analysis of DCE-MRI data).
Time Frame Cycle 3 (Day 1), Cycle 3 (Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
No pharmacodynamic assessments were performed due to limited number of DCE-MRI scans collected.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2) 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
30.Secondary Outcome
Title Initial Area Dnder the Contrast Agent Concentration-Time Curve (IAUC) of Tumors in a Selected Group of Subjects Assessed by DCE-MRI
Hide Description IAUC: The initial area under the curve was estimated by integrating the area under the contrast agent concentration time course for the first 90 seconds after bolus arrival in the tumor.
Time Frame Cycle 3 (Day 1) and Cycle 3 (Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
No pharmacodynamic assessments were performed due to limited number of DCE-MRI scans collected.
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2) 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Hide Arm/Group Description:
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
Overall Number of Participants Analyzed 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2) 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) 37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing) 25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Hide Arm/Group Description Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6. CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6. Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6 Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6 Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6. Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
All-Cause Mortality
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2) 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) 37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing) 25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2) 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) 37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing) 25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   4/9 (44.44%)   0/5 (0.00%)   7/12 (58.33%)   3/9 (33.33%)   2/6 (33.33%)   4/8 (50.00%) 
Blood and lymphatic system disorders               
Disseminated intravascular coagulation  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Febrile neutropenia  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  1/12 (8.33%)  1/9 (11.11%)  0/6 (0.00%)  0/8 (0.00%) 
Neutropenia  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Thrombocytopenia  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Gastrointestinal disorders               
Abdominal pain  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  2/12 (16.67%)  0/9 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Nausea  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Oral pain  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Small intestinal obstruction  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Vomiting  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
General disorders               
Disease progression  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  2/6 (33.33%)  0/8 (0.00%) 
Mucosal inflammation  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Pyrexia  1  0/4 (0.00%)  2/9 (22.22%)  0/5 (0.00%)  2/12 (16.67%)  0/9 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Hepatobiliary disorders               
Cholangitis  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Cholecystitis acute  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/8 (0.00%) 
Hepatic failure  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Hyperbilirubinaemia  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Jaundice cholestatic  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Infections and infestations               
Catheter site infection  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Infection  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Liver abscess  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Pneumonia  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Sepsis  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/6 (0.00%)  2/8 (25.00%) 
Investigations               
Blood bilirubin increased  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Metabolism and nutrition disorders               
Anorexia  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/8 (0.00%) 
Dehydration  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  1/6 (16.67%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Epistaxis  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Pulmonary embolism  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  1/12 (8.33%)  1/9 (11.11%)  0/6 (0.00%)  0/8 (0.00%) 
Vascular disorders               
Deep vein thrombosis  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2) 50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2) 37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) 50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2) 37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing) 25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/4 (100.00%)   9/9 (100.00%)   5/5 (100.00%)   12/12 (100.00%)   9/9 (100.00%)   6/6 (100.00%)   8/8 (100.00%) 
Blood and lymphatic system disorders               
Anaemia  1  3/4 (75.00%)  7/9 (77.78%)  0/5 (0.00%)  3/12 (25.00%)  3/9 (33.33%)  1/6 (16.67%)  1/8 (12.50%) 
Leukopenia  1  1/4 (25.00%)  4/9 (44.44%)  1/5 (20.00%)  0/12 (0.00%)  2/9 (22.22%)  1/6 (16.67%)  0/8 (0.00%) 
Neutropenia  1  4/4 (100.00%)  9/9 (100.00%)  3/5 (60.00%)  5/12 (41.67%)  8/9 (88.89%)  4/6 (66.67%)  5/8 (62.50%) 
Thrombocytopenia  1  3/4 (75.00%)  6/9 (66.67%)  2/5 (40.00%)  2/12 (16.67%)  5/9 (55.56%)  3/6 (50.00%)  3/8 (37.50%) 
Eye disorders               
Vision blurred  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  1/6 (16.67%)  0/8 (0.00%) 
Visual impairment  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  2/6 (33.33%)  0/8 (0.00%) 
Gastrointestinal disorders               
Abdominal distension  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  1/12 (8.33%)  1/9 (11.11%)  1/6 (16.67%)  0/8 (0.00%) 
Abdominal pain  1  0/4 (0.00%)  5/9 (55.56%)  1/5 (20.00%)  2/12 (16.67%)  4/9 (44.44%)  3/6 (50.00%)  3/8 (37.50%) 
Abdominal pain upper  1  0/4 (0.00%)  3/9 (33.33%)  0/5 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Constipation  1  2/4 (50.00%)  5/9 (55.56%)  1/5 (20.00%)  4/12 (33.33%)  2/9 (22.22%)  1/6 (16.67%)  1/8 (12.50%) 
Diarrhoea  1  1/4 (25.00%)  4/9 (44.44%)  4/5 (80.00%)  4/12 (33.33%)  5/9 (55.56%)  2/6 (33.33%)  3/8 (37.50%) 
Dyspepsia  1  1/4 (25.00%)  3/9 (33.33%)  2/5 (40.00%)  4/12 (33.33%)  2/9 (22.22%)  2/6 (33.33%)  0/8 (0.00%) 
Dysphagia  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  3/9 (33.33%)  0/6 (0.00%)  0/8 (0.00%) 
Flatulence  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  0/12 (0.00%)  3/9 (33.33%)  0/6 (0.00%)  0/8 (0.00%) 
Haemorrhoids  1  1/4 (25.00%)  0/9 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Nausea  1  1/4 (25.00%)  5/9 (55.56%)  4/5 (80.00%)  7/12 (58.33%)  5/9 (55.56%)  4/6 (66.67%)  5/8 (62.50%) 
Oral pain  1  1/4 (25.00%)  0/9 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  1/6 (16.67%)  0/8 (0.00%) 
Rectal haemorrhage  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  0/12 (0.00%)  3/9 (33.33%)  0/6 (0.00%)  0/8 (0.00%) 
Stomatitis  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  2/6 (33.33%)  2/8 (25.00%) 
Vomiting  1  0/4 (0.00%)  5/9 (55.56%)  4/5 (80.00%)  5/12 (41.67%)  5/9 (55.56%)  5/6 (83.33%)  3/8 (37.50%) 
General disorders               
Chest pain  1  0/4 (0.00%)  4/9 (44.44%)  0/5 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Chills  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  1/12 (8.33%)  3/9 (33.33%)  1/6 (16.67%)  1/8 (12.50%) 
Fatigue  1  2/4 (50.00%)  6/9 (66.67%)  2/5 (40.00%)  6/12 (50.00%)  7/9 (77.78%)  5/6 (83.33%)  4/8 (50.00%) 
Mucosal inflammation  1  2/4 (50.00%)  1/9 (11.11%)  3/5 (60.00%)  3/12 (25.00%)  4/9 (44.44%)  2/6 (33.33%)  1/8 (12.50%) 
Oedema peripheral  1  0/4 (0.00%)  2/9 (22.22%)  0/5 (0.00%)  2/12 (16.67%)  3/9 (33.33%)  2/6 (33.33%)  0/8 (0.00%) 
Pyrexia  1  1/4 (25.00%)  1/9 (11.11%)  0/5 (0.00%)  4/12 (33.33%)  4/9 (44.44%)  0/6 (0.00%)  3/8 (37.50%) 
Temperature intolerance  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  2/8 (25.00%) 
Hepatobiliary disorders               
Hyperbilirubinaemia  1  0/4 (0.00%)  2/9 (22.22%)  1/5 (20.00%)  2/12 (16.67%)  1/9 (11.11%)  1/6 (16.67%)  1/8 (12.50%) 
Jaundice  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  1/6 (16.67%)  0/8 (0.00%) 
Infections and infestations               
Upper respiratory tract infection  1  0/4 (0.00%)  2/9 (22.22%)  2/5 (40.00%)  0/12 (0.00%)  1/9 (11.11%)  1/6 (16.67%)  0/8 (0.00%) 
Urinary tract infection  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  2/12 (16.67%)  1/9 (11.11%)  0/6 (0.00%)  1/8 (12.50%) 
Investigations               
Alanine aminotransferase increased  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  2/12 (16.67%)  0/9 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Aspartate aminotransferase  1  0/4 (0.00%)  2/9 (22.22%)  0/5 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  1/6 (16.67%)  0/8 (0.00%) 
Aspartate aminotransferase increased  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  1/12 (8.33%)  1/9 (11.11%)  0/6 (0.00%)  1/8 (12.50%) 
Blood alkaline phosphatase  1  0/4 (0.00%)  2/9 (22.22%)  0/5 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  0/8 (0.00%) 
Blood alkaline phosphatase increased  1  0/4 (0.00%)  1/9 (11.11%)  1/5 (20.00%)  2/12 (16.67%)  0/9 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Blood bilirubin increased  1  1/4 (25.00%)  1/9 (11.11%)  0/5 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Blood creatinine increased  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  0/6 (0.00%)  3/8 (37.50%) 
Haemoglobin decreased  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  3/12 (25.00%)  0/9 (0.00%)  0/6 (0.00%)  3/8 (37.50%) 
Neutrophil count decreased  1  0/4 (0.00%)  0/9 (0.00%)  1/5 (20.00%)  3/12 (25.00%)  0/9 (0.00%)  0/6 (0.00%)  4/8 (50.00%) 
Platelet count decreased  1  0/4 (0.00%)  0/9 (0.00%)  1/5 (20.00%)  5/12 (41.67%)  1/9 (11.11%)  0/6 (0.00%)  2/8 (25.00%) 
Weight decreased  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  2/12 (16.67%)  1/9 (11.11%)  0/6 (0.00%)  0/8 (0.00%) 
White blood cell count decreased  1  0/4 (0.00%)  0/9 (0.00%)  1/5 (20.00%)  4/12 (33.33%)  0/9 (0.00%)  0/6 (0.00%)  3/8 (37.50%) 
Metabolism and nutrition disorders               
Anorexia  1  1/4 (25.00%)  3/9 (33.33%)  2/5 (40.00%)  1/12 (8.33%)  4/9 (44.44%)  3/6 (50.00%)  1/8 (12.50%) 
Dehydration  1  1/4 (25.00%)  3/9 (33.33%)  1/5 (20.00%)  0/12 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  1/8 (12.50%) 
Hyperglycaemia  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  2/12 (16.67%)  1/9 (11.11%)  1/6 (16.67%)  0/8 (0.00%) 
Hypoalbuminaemia  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  2/12 (16.67%)  1/9 (11.11%)  1/6 (16.67%)  2/8 (25.00%) 
Hypocalcaemia  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  1/9 (11.11%)  0/6 (0.00%)  1/8 (12.50%) 
Hypokalaemia  1  1/4 (25.00%)  3/9 (33.33%)  2/5 (40.00%)  4/12 (33.33%)  2/9 (22.22%)  0/6 (0.00%)  2/8 (25.00%) 
Hyponatraemia  1  1/4 (25.00%)  0/9 (0.00%)  0/5 (0.00%)  2/12 (16.67%)  2/9 (22.22%)  0/6 (0.00%)  1/8 (12.50%) 
Hypophosphataemia  1  0/4 (0.00%)  3/9 (33.33%)  0/5 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  1/6 (16.67%)  1/8 (12.50%) 
Musculoskeletal and connective tissue disorders               
Back pain  1  1/4 (25.00%)  2/9 (22.22%)  0/5 (0.00%)  0/12 (0.00%)  2/9 (22.22%)  0/6 (0.00%)  0/8 (0.00%) 
Myalgia  1  1/4 (25.00%)  0/9 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  1/6 (16.67%)  0/8 (0.00%) 
Pain in extremity  1  0/4 (0.00%)  2/9 (22.22%)  1/5 (20.00%)  0/12 (0.00%)  1/9 (11.11%)  1/6 (16.67%)  1/8 (12.50%) 
Nervous system disorders               
Dizziness  1  1/4 (25.00%)  1/9 (11.11%)  0/5 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/6 (0.00%)  1/8 (12.50%) 
Dysgeusia  1  0/4 (0.00%)  1/9 (11.11%)  1/5 (20.00%)  4/12 (33.33%)  2/9 (22.22%)  1/6 (16.67%)  3/8 (37.50%) 
Headache  1  0/4 (0.00%)  4/9 (44.44%)  1/5 (20.00%)  2/12 (16.67%)  1/9 (11.11%)  0/6 (0.00%)  2/8 (25.00%) 
Hyperaesthesia  1  1/4 (25.00%)  1/9 (11.11%)  1/5 (20.00%)  3/12 (25.00%)  1/9 (11.11%)  1/6 (16.67%)  1/8 (12.50%) 
Neuropathy peripheral  1  1/4 (25.00%)  1/9 (11.11%)  1/5 (20.00%)  3/12 (25.00%)  4/9 (44.44%)  1/6 (16.67%)  1/8 (12.50%) 
Paraesthesia  1  2/4 (50.00%)  1/9 (11.11%)  1/5 (20.00%)  1/12 (8.33%)  0/9 (0.00%)  0/6 (0.00%)  2/8 (25.00%) 
Peripheral sensory neuropathy  1  0/4 (0.00%)  5/9 (55.56%)  1/5 (20.00%)  1/12 (8.33%)  5/9 (55.56%)  3/6 (50.00%)  1/8 (12.50%) 
Psychiatric disorders               
Anxiety  1  0/4 (0.00%)  2/9 (22.22%)  0/5 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  0/8 (0.00%) 
Insomnia  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  0/12 (0.00%)  2/9 (22.22%)  1/6 (16.67%)  0/8 (0.00%) 
Mental status changes  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  1/12 (8.33%)  1/9 (11.11%)  1/6 (16.67%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders               
Cough  1  0/4 (0.00%)  4/9 (44.44%)  1/5 (20.00%)  0/12 (0.00%)  3/9 (33.33%)  0/6 (0.00%)  0/8 (0.00%) 
Dyspnoea  1  1/4 (25.00%)  1/9 (11.11%)  0/5 (0.00%)  0/12 (0.00%)  0/9 (0.00%)  1/6 (16.67%)  1/8 (12.50%) 
Epistaxis  1  1/4 (25.00%)  2/9 (22.22%)  1/5 (20.00%)  1/12 (8.33%)  3/9 (33.33%)  0/6 (0.00%)  3/8 (37.50%) 
Hiccups  1  1/4 (25.00%)  3/9 (33.33%)  0/5 (0.00%)  0/12 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  1/8 (12.50%) 
Oropharyngeal pain  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  2/12 (16.67%)  2/9 (22.22%)  0/6 (0.00%)  0/8 (0.00%) 
Skin and subcutaneous tissue disorders               
Alopecia  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  1/12 (8.33%)  2/9 (22.22%)  0/6 (0.00%)  1/8 (12.50%) 
Dry skin  1  2/4 (50.00%)  1/9 (11.11%)  1/5 (20.00%)  0/12 (0.00%)  1/9 (11.11%)  1/6 (16.67%)  0/8 (0.00%) 
Palmar—plantar erythrodysaesthesia syndrome  1  0/4 (0.00%)  0/9 (0.00%)  0/5 (0.00%)  0/12 (0.00%)  2/9 (22.22%)  1/6 (16.67%)  1/8 (12.50%) 
Pruritus  1  1/4 (25.00%)  1/9 (11.11%)  0/5 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/6 (0.00%)  2/8 (25.00%) 
Rash  1  0/4 (0.00%)  1/9 (11.11%)  0/5 (0.00%)  1/12 (8.33%)  2/9 (22.22%)  1/6 (16.67%)  2/8 (25.00%) 
Skin exfoliation  1  1/4 (25.00%)  1/9 (11.11%)  0/5 (0.00%)  1/12 (8.33%)  0/9 (0.00%)  0/6 (0.00%)  0/8 (0.00%) 
Vascular disorders               
Hypertension  1  0/4 (0.00%)  1/9 (11.11%)  2/5 (40.00%)  0/12 (0.00%)  1/9 (11.11%)  0/6 (0.00%)  2/8 (25.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.govCallCenter@pfizer.com
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00599924     History of Changes
Other Study ID Numbers: A6181048
First Submitted: January 11, 2008
First Posted: January 24, 2008
Results First Submitted: November 4, 2009
Results First Posted: December 9, 2009
Last Update Posted: July 15, 2015