Trial Outcomes & Findings for Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors (NCT NCT00599924)
NCT ID: NCT00599924
Last Updated: 2015-07-15
Results Overview
All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
53 participants
Primary outcome timeframe
up to 20 weeks
Results posted on
2015-07-15
Participant Flow
Participant milestones
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
9
|
5
|
12
|
9
|
6
|
8
|
|
Overall Study
COMPLETED
|
1
|
4
|
3
|
4
|
3
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
2
|
8
|
6
|
4
|
5
|
Reasons for withdrawal
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
3
|
5
|
1
|
2
|
3
|
2
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
2
|
0
|
0
|
2
|
|
Overall Study
Death
|
0
|
0
|
0
|
2
|
0
|
2
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
1
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
2
|
0
|
2
|
Baseline Characteristics
Study Of Sunitinib Plus FOLFOX In Patients With Solid Tumors
Baseline characteristics by cohort
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=9 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
n=5 Participants
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
n=12 Participants
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
n=9 Participants
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
n=6 Participants
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
n=8 Participants
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Customized
< 65 years
|
2 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
7 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=8 Participants
|
5 participants
n=8 Participants
|
37 participants
n=24 Participants
|
|
Age, Customized
> = 65 years
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
5 participants
n=4 Participants
|
3 participants
n=21 Participants
|
0 participants
n=8 Participants
|
3 participants
n=8 Participants
|
16 participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
34 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: up to 20 weeksPopulation: 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.
All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to the investigational product(s) were reported.
Outcome measures
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=9 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
n=5 Participants
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
n=12 Participants
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
n=9 Participants
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
n=6 Participants
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
n=8 Participants
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs
|
4 participants
|
9 participants
|
5 participants
|
12 participants
|
9 participants
|
6 participants
|
8 participants
|
|
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
0 participants
|
4 participants
|
0 participants
|
7 participants
|
3 participants
|
2 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 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)Population: ITT
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.
Outcome measures
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=9 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
n=5 Participants
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
n=12 Participants
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
n=9 Participants
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
n=6 Participants
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
n=8 Participants
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Objective Response (OR)
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dosePopulation: ITT population of subjects who had completed pharmacokinetic (PK) blood sampling for at least one day.
Outcome measures
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=8 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Sunitinib
Cycle 1, Day 14
|
47.13 ng/mL
Standard Deviation 13.165
|
61.36 ng/mL
Standard Deviation 14.692
|
—
|
—
|
—
|
—
|
—
|
|
Maximum Plasma Concentration (Cmax) of Sunitinib
Cycle 2, Day 1
|
44.95 ng/mL
Standard Deviation 14.272
|
60.24 ng/mL
Standard Deviation 13.830
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dosePopulation: ITT population of subjects who had completed PK blood sampling for at least one day.
Outcome measures
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=8 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Time to Cmax (Tmax) of Sunitinib
Cycle 1, Day 14
|
8.00 hours
Interval 6.0 to 10.0
|
10.00 hours
Interval 4.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
|
Time to Cmax (Tmax) of Sunitinib
Cycle 2, Day 1
|
7.00 hours
Interval 6.0 to 24.0
|
8.00 hours
Interval 4.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dosePopulation: ITT population of subjects who had completed PK blood sampling for at least one day.
Outcome measures
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=8 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Minimum Plasma Concentration (Cmin) of Sunitinib
Cycle 1, Day 14
|
34.95 ng/mL
Standard Deviation 10.618
|
38.23 ng/mL
Standard Deviation 11.629
|
—
|
—
|
—
|
—
|
—
|
|
Minimum Plasma Concentration (Cmin) of Sunitinib
Cycle 2, Day 1
|
30.28 ng/mL
Standard Deviation 10.188
|
39.47 ng/mL
Standard Deviation 16.632
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dosePopulation: ITT population of subjects who had completed PK blood sampling for at least one day.
Drug clearance (CL/F) = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.
Outcome measures
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=8 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Clearance (CL/F) of Sunitinib
Cycle 1, Day 14
|
41.13 L/hr
Standard Deviation 10.104
|
44.29 L/hr
Standard Deviation 5.663
|
—
|
—
|
—
|
—
|
—
|
|
Clearance (CL/F) of Sunitinib
Cycle 2, Day 1
|
42.40 L/hr
Standard Deviation 12.700
|
49.44 L/hr
Standard Deviation 16.211
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dosePopulation: ITT population of subjects who had completed PK blood sampling for at least one day.
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.
Outcome measures
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=8 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Area Under Plasma Concentration-Time Profile From Time Zero to Twenty-Four Hours Postdose (AUC24) of Sunitinib
Cycle 1, Day 14
|
985.43 ng*hr/mL
Standard Deviation 251.046
|
1233.73 ng*hr/mL
Standard Deviation 322.353
|
—
|
—
|
—
|
—
|
—
|
|
Area Under Plasma Concentration-Time Profile From Time Zero to Twenty-Four Hours Postdose (AUC24) of Sunitinib
Cycle 2, Day 1
|
948.40 ng*hr/mL
Standard Deviation 284.871
|
1202.50 ng*hr/mL
Standard Deviation 396.337
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dosePopulation: T1/2 for sunitinib was not calculated due to short observation time.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dosePopulation: ITT population of subjects who had completed PK blood sampling for at least one day.
Outcome measures
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=8 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Cmax of SU-012662 (Sunitinib's Metabolite)
Cycle 1, Day 14
|
18.95 ng/mL
Standard Deviation 3.007
|
22.80 ng/mL
Standard Deviation 5.189
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of SU-012662 (Sunitinib's Metabolite)
Cycle 2, Day 1
|
18.75 ng/mL
Standard Deviation 2.977
|
23.44 ng/mL
Standard Deviation 7.094
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dosePopulation: ITT population of subjects who had completed PK blood sampling for at least one day.
Outcome measures
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=8 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Tmax of SU-012662 (Sunitinib's Metabolite)
Cycle 1, Day 14
|
8.00 hours
Interval 6.0 to 10.0
|
10.00 hours
Interval 0.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
|
Tmax of SU-012662 (Sunitinib's Metabolite)
Cycle 2, Day 1
|
15.00 hours
Interval 0.0 to 24.0
|
4.00 hours
Interval 2.0 to 24.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-doseOutcome measures
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=8 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Cmin of SU-012662 (Sunitinib's Metabolite)
Cycle 2, Day 1
|
13.59 ng/mL
Standard Deviation 4.585
|
17.68 ng/mL
Standard Deviation 5.599
|
—
|
—
|
—
|
—
|
—
|
|
Cmin of SU-012662 (Sunitinib's Metabolite)
Cycle 1, Day 14
|
14.45 ng/mL
Standard Deviation 3.497
|
15.70 ng/mL
Standard Deviation 4.365
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dose.Population: ITT population of subjects who had completed PK blood sampling for at least one day.
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.
Outcome measures
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=8 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
AUC24 for SU-012662 (Sunitinib's Metabolite)
Cycle 1, Day 14
|
401.51 ng*hr/mL
Standard Deviation 63.164
|
468.79 ng*hr/mL
Standard Deviation 117.108
|
—
|
—
|
—
|
—
|
—
|
|
AUC24 for SU-012662 (Sunitinib's Metabolite)
Cycle 2, Day 1
|
395.82 ng*hr/mL
Standard Deviation 66.618
|
495.97 ng*hr/mL
Standard Deviation 154.314
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dosePopulation: CL/F was not calculated for SU-012662.
CL/F = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dosePopulation: T1/2 for SU-012662 was not calculated due to short observation time.
t1/2 = terminal phase half-life. t1/2 was obtained by ln2 divided by kel.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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-dosePopulation: ITT population of subjects who had completed PK blood sampling for at least one day.
Oxaliplatin was metabolized to platinum and free platinum was measured.
Outcome measures
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=11 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Cmax of Free Platinum
Cycle 1, Day 1
|
935.25 ng/mL
Standard Deviation 442.974
|
634.00 ng/mL
Standard Deviation 134.050
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of Free Platinum
Cycle 2, Day 1
|
1043.75 ng/mL
Standard Deviation 381.656
|
789.43 ng/mL
Standard Deviation 239.650
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: ITT population of subjects who had completed PK blood sampling for at least one day.
Oxaliplatin was metabolized to platinum and free platinum was measured.
Outcome measures
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=11 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Tmax of Free Platinum
Cycle 1, Day 1
|
2.00 hours
Interval 1.0 to 2.0
|
2.00 hours
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
|
Tmax of Free Platinum
Cycle 2, Day 1
|
2.00 hours
Interval 2.0 to 2.0
|
2.00 hours
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: ITT population of subjects who had completed PK blood sampling for at least one day.
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.
Outcome measures
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=11 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) for Free Platinum
Cycle 1, Day 1
|
7459.28 ng*hr/mL
Standard Deviation 2892.442
|
6490.17 ng*hr/mL
Standard Deviation 1947.621
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to Infinity (AUCinf) for Free Platinum
Cycle 2, Day 1
|
7942.64 ng*hr/mL
Standard Deviation 3043.567
|
7092.65 ng*hr/mL
Standard Deviation 1906.756
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: ITT population of subjects who had completed PK blood sampling for at least one day.
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.
Outcome measures
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=11 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
T1/2 for Free Platinum
Cycle 1, Day 1
|
16.15 hours
Standard Deviation 3.077
|
15.60 hours
Standard Deviation 2.038
|
—
|
—
|
—
|
—
|
—
|
|
T1/2 for Free Platinum
Cycle 2, Day 1
|
18.55 hours
Standard Deviation 5.622
|
31.20 hours
Standard Deviation 37.925
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: ITT population of subjects who had completed PK blood sampling for at least one day.
Oxaliplatin was metabolized to platinum and total platinum was measured.
Outcome measures
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=12 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Cmax of Total Platinum
Cycle 1, Day 1
|
2490.00 ng/mL
Standard Deviation 748.465
|
2137.14 ng/mL
Standard Deviation 415.681
|
—
|
—
|
—
|
—
|
—
|
|
Cmax of Total Platinum
Cycle 2, Day 1
|
2905.00 ng/mL
Standard Deviation 636.684
|
2641.43 ng/mL
Standard Deviation 387.145
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: ITT population of subjects who had completed PK blood sampling for at least one day.
Oxaliplatin was metabolized to platinum and total platinum was measured.
Outcome measures
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=12 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Tmax of Total Platinum
Cycle 1, Day 1
|
2.00 hours
Interval 2.0 to 2.0
|
2.00 hours
Interval 1.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
|
Tmax of Total Platinum
Cycle 2, Day 1
|
2.00 hours
Interval 2.0 to 2.0
|
2.00 hours
Interval 2.0 to 2.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: ITT population of subjects who had completed PK blood sampling for at least one day.
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.
Outcome measures
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=12 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to Forty-Eight Hours (AUC48) for Total Platinum
Cycle 1, Day 1
|
47264.02 ng*hr/mL
Standard Deviation 10509.556
|
43713.95 ng*hr/mL
Standard Deviation 5590.750
|
—
|
—
|
—
|
—
|
—
|
|
Area Under the Plasma Concentration-Time Profile From Time Zero to Forty-Eight Hours (AUC48) for Total Platinum
Cycle 2, Day 1
|
56813.62 ng*hr/mL
Standard Deviation 11980.029
|
51962.03 ng*hr/mL
Standard Deviation 8118.343
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: ITT population of subjects who had completed PK blood sampling for at least one day.
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.
Outcome measures
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=12 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Steady State Concentration (Css) of Fluorouracil (5-FU)
Cycle 1, Day 1
|
567.52 ng/mL
Standard Deviation 351.207
|
334.26 ng/mL
Standard Deviation 89.579
|
—
|
—
|
—
|
—
|
—
|
|
Steady State Concentration (Css) of Fluorouracil (5-FU)
Cycle 2, Day 1
|
598.86 ng/mL
Standard Deviation 127.635
|
647.32 ng/mL
Standard Deviation 284.203
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: ITT population of subjects who had completed PK blood sampling for at least one day.
CLss was determined by total amount of drug received during infusion or duration of infusion (Ki) divided by Css.
Outcome measures
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=12 Participants
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Steady State Clearance (CLss) of 5-FU
Cycle 2, Day 1
|
174.51 L/hr
Standard Deviation 49.445
|
201.12 L/hr
Standard Deviation 103.534
|
—
|
—
|
—
|
—
|
—
|
|
Steady State Clearance (CLss) of 5-FU
Cycle 1, Day 1
|
284.99 L/hr
Standard Deviation 147.808
|
312.63 L/hr
Standard Deviation 93.563
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: AUC for 5-FU was not calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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-dosePopulation: Cmax of 5-FU was not calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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-dosePopulation: T1/2 was not calculated for Free Platinum, Total Platinum, and 5-FU.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 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-dosePopulation: CL/F was not calculated for Free Platinum, Total Platinum, and 5-FU.
CL/F = dose divided by area under the plasma concentration-time profile from time zero to twenty-four hours.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: pre-dose, 1, 2, 4, 6, 8, 10, and 24 hours post-dosePopulation: Cmin was not calculated for Free Platinum, Total Platinum, and 5-FU.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 3 (Day 1), Cycle 3 (Day 8)Population: No pharmacodynamic assessments were performed due to limited number of DCE-MRI scans collected.
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).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 3 (Day 1) and Cycle 3 (Day 8)Population: No pharmacodynamic assessments were performed due to limited number of DCE-MRI scans collected.
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.
Outcome measures
Outcome data not reported
Adverse Events
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Serious events: 7 serious events
Other events: 12 other events
Deaths: 0 deaths
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 participants at risk
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=9 participants at risk
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
n=5 participants at risk
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
n=12 participants at risk
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
n=9 participants at risk
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
n=6 participants at risk
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
n=8 participants at risk
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
8.3%
1/12
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
8.3%
1/12
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/6
|
12.5%
1/8
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
8.3%
1/12
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
8.3%
1/12
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/6
|
12.5%
1/8
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
16.7%
2/12
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
8.3%
1/12
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
8.3%
1/12
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
8.3%
1/12
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/8
|
|
General disorders
Disease progression
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
8.3%
1/12
|
0.00%
0/9
|
33.3%
2/6
|
0.00%
0/8
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
8.3%
1/12
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/8
|
|
General disorders
Pyrexia
|
0.00%
0/4
|
22.2%
2/9
|
0.00%
0/5
|
16.7%
2/12
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
8.3%
1/12
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/12
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/6
|
12.5%
1/8
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
8.3%
1/12
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
8.3%
1/12
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Infections and infestations
Infection
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/6
|
12.5%
1/8
|
|
Infections and infestations
Liver abscess
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/6
|
12.5%
1/8
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/6
|
12.5%
1/8
|
|
Infections and infestations
Sepsis
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
8.3%
1/12
|
0.00%
0/9
|
0.00%
0/6
|
25.0%
2/8
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/12
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
8.3%
1/12
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/8
|
Other adverse events
| Measure |
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=4 participants at risk
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.
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)
n=9 participants at risk
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.
|
50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)
n=5 participants at risk
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.
|
37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
n=12 participants at risk
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)
n=9 participants at risk
Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
|
37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
n=6 participants at risk
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)
n=8 participants at risk
Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
0.00%
0/12
|
11.1%
1/9
|
33.3%
2/6
|
25.0%
2/8
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4
|
55.6%
5/9
|
80.0%
4/5
|
41.7%
5/12
|
55.6%
5/9
|
83.3%
5/6
|
37.5%
3/8
|
|
General disorders
Chest pain
|
0.00%
0/4
|
44.4%
4/9
|
0.00%
0/5
|
8.3%
1/12
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/8
|
|
General disorders
Chills
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
8.3%
1/12
|
33.3%
3/9
|
16.7%
1/6
|
12.5%
1/8
|
|
General disorders
Fatigue
|
50.0%
2/4
|
66.7%
6/9
|
40.0%
2/5
|
50.0%
6/12
|
77.8%
7/9
|
83.3%
5/6
|
50.0%
4/8
|
|
General disorders
Mucosal inflammation
|
50.0%
2/4
|
11.1%
1/9
|
60.0%
3/5
|
25.0%
3/12
|
44.4%
4/9
|
33.3%
2/6
|
12.5%
1/8
|
|
General disorders
Oedema peripheral
|
0.00%
0/4
|
22.2%
2/9
|
0.00%
0/5
|
16.7%
2/12
|
33.3%
3/9
|
33.3%
2/6
|
0.00%
0/8
|
|
General disorders
Pyrexia
|
25.0%
1/4
|
11.1%
1/9
|
0.00%
0/5
|
33.3%
4/12
|
44.4%
4/9
|
0.00%
0/6
|
37.5%
3/8
|
|
General disorders
Temperature intolerance
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/12
|
0.00%
0/9
|
16.7%
1/6
|
25.0%
2/8
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/4
|
22.2%
2/9
|
20.0%
1/5
|
16.7%
2/12
|
11.1%
1/9
|
16.7%
1/6
|
12.5%
1/8
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
8.3%
1/12
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/8
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4
|
22.2%
2/9
|
40.0%
2/5
|
0.00%
0/12
|
11.1%
1/9
|
16.7%
1/6
|
0.00%
0/8
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
16.7%
2/12
|
11.1%
1/9
|
0.00%
0/6
|
12.5%
1/8
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
16.7%
2/12
|
0.00%
0/9
|
0.00%
0/6
|
12.5%
1/8
|
|
Investigations
Aspartate aminotransferase
|
0.00%
0/4
|
22.2%
2/9
|
0.00%
0/5
|
0.00%
0/12
|
11.1%
1/9
|
16.7%
1/6
|
0.00%
0/8
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
8.3%
1/12
|
11.1%
1/9
|
0.00%
0/6
|
12.5%
1/8
|
|
Investigations
Blood alkaline phosphatase
|
0.00%
0/4
|
22.2%
2/9
|
0.00%
0/5
|
0.00%
0/12
|
0.00%
0/9
|
16.7%
1/6
|
0.00%
0/8
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4
|
11.1%
1/9
|
20.0%
1/5
|
16.7%
2/12
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4
|
11.1%
1/9
|
0.00%
0/5
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/6
|
12.5%
1/8
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/6
|
37.5%
3/8
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
25.0%
3/12
|
0.00%
0/9
|
0.00%
0/6
|
37.5%
3/8
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4
|
0.00%
0/9
|
20.0%
1/5
|
25.0%
3/12
|
0.00%
0/9
|
0.00%
0/6
|
50.0%
4/8
|
|
Investigations
Platelet count decreased
|
0.00%
0/4
|
0.00%
0/9
|
20.0%
1/5
|
41.7%
5/12
|
11.1%
1/9
|
0.00%
0/6
|
25.0%
2/8
|
|
Investigations
Weight decreased
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
16.7%
2/12
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Investigations
White blood cell count decreased
|
0.00%
0/4
|
0.00%
0/9
|
20.0%
1/5
|
33.3%
4/12
|
0.00%
0/9
|
0.00%
0/6
|
37.5%
3/8
|
|
Blood and lymphatic system disorders
Anaemia
|
75.0%
3/4
|
77.8%
7/9
|
0.00%
0/5
|
25.0%
3/12
|
33.3%
3/9
|
16.7%
1/6
|
12.5%
1/8
|
|
Blood and lymphatic system disorders
Leukopenia
|
25.0%
1/4
|
44.4%
4/9
|
20.0%
1/5
|
0.00%
0/12
|
22.2%
2/9
|
16.7%
1/6
|
0.00%
0/8
|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
4/4
|
100.0%
9/9
|
60.0%
3/5
|
41.7%
5/12
|
88.9%
8/9
|
66.7%
4/6
|
62.5%
5/8
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
75.0%
3/4
|
66.7%
6/9
|
40.0%
2/5
|
16.7%
2/12
|
55.6%
5/9
|
50.0%
3/6
|
37.5%
3/8
|
|
Eye disorders
Vision blurred
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
0.00%
0/12
|
11.1%
1/9
|
16.7%
1/6
|
0.00%
0/8
|
|
Eye disorders
Visual impairment
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
8.3%
1/12
|
0.00%
0/9
|
33.3%
2/6
|
0.00%
0/8
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
8.3%
1/12
|
11.1%
1/9
|
16.7%
1/6
|
0.00%
0/8
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4
|
55.6%
5/9
|
20.0%
1/5
|
16.7%
2/12
|
44.4%
4/9
|
50.0%
3/6
|
37.5%
3/8
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4
|
33.3%
3/9
|
0.00%
0/5
|
0.00%
0/12
|
0.00%
0/9
|
0.00%
0/6
|
12.5%
1/8
|
|
Gastrointestinal disorders
Constipation
|
50.0%
2/4
|
55.6%
5/9
|
20.0%
1/5
|
33.3%
4/12
|
22.2%
2/9
|
16.7%
1/6
|
12.5%
1/8
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4
|
44.4%
4/9
|
80.0%
4/5
|
33.3%
4/12
|
55.6%
5/9
|
33.3%
2/6
|
37.5%
3/8
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4
|
33.3%
3/9
|
40.0%
2/5
|
33.3%
4/12
|
22.2%
2/9
|
33.3%
2/6
|
0.00%
0/8
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/12
|
33.3%
3/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
0.00%
0/12
|
33.3%
3/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Gastrointestinal disorders
Haemorrhoids
|
25.0%
1/4
|
0.00%
0/9
|
0.00%
0/5
|
8.3%
1/12
|
0.00%
0/9
|
0.00%
0/6
|
12.5%
1/8
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4
|
55.6%
5/9
|
80.0%
4/5
|
58.3%
7/12
|
55.6%
5/9
|
66.7%
4/6
|
62.5%
5/8
|
|
Gastrointestinal disorders
Oral pain
|
25.0%
1/4
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/12
|
11.1%
1/9
|
16.7%
1/6
|
0.00%
0/8
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
0.00%
0/12
|
33.3%
3/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Anorexia
|
25.0%
1/4
|
33.3%
3/9
|
40.0%
2/5
|
8.3%
1/12
|
44.4%
4/9
|
50.0%
3/6
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
1/4
|
33.3%
3/9
|
20.0%
1/5
|
0.00%
0/12
|
11.1%
1/9
|
0.00%
0/6
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
16.7%
2/12
|
11.1%
1/9
|
16.7%
1/6
|
0.00%
0/8
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
16.7%
2/12
|
11.1%
1/9
|
16.7%
1/6
|
25.0%
2/8
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
8.3%
1/12
|
11.1%
1/9
|
0.00%
0/6
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
25.0%
1/4
|
33.3%
3/9
|
40.0%
2/5
|
33.3%
4/12
|
22.2%
2/9
|
0.00%
0/6
|
25.0%
2/8
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4
|
0.00%
0/9
|
0.00%
0/5
|
16.7%
2/12
|
22.2%
2/9
|
0.00%
0/6
|
12.5%
1/8
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/4
|
33.3%
3/9
|
0.00%
0/5
|
0.00%
0/12
|
11.1%
1/9
|
16.7%
1/6
|
12.5%
1/8
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
1/4
|
22.2%
2/9
|
0.00%
0/5
|
0.00%
0/12
|
22.2%
2/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/12
|
11.1%
1/9
|
16.7%
1/6
|
0.00%
0/8
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4
|
22.2%
2/9
|
20.0%
1/5
|
0.00%
0/12
|
11.1%
1/9
|
16.7%
1/6
|
12.5%
1/8
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4
|
11.1%
1/9
|
0.00%
0/5
|
8.3%
1/12
|
0.00%
0/9
|
0.00%
0/6
|
12.5%
1/8
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4
|
11.1%
1/9
|
20.0%
1/5
|
33.3%
4/12
|
22.2%
2/9
|
16.7%
1/6
|
37.5%
3/8
|
|
Nervous system disorders
Headache
|
0.00%
0/4
|
44.4%
4/9
|
20.0%
1/5
|
16.7%
2/12
|
11.1%
1/9
|
0.00%
0/6
|
25.0%
2/8
|
|
Nervous system disorders
Hyperaesthesia
|
25.0%
1/4
|
11.1%
1/9
|
20.0%
1/5
|
25.0%
3/12
|
11.1%
1/9
|
16.7%
1/6
|
12.5%
1/8
|
|
Nervous system disorders
Neuropathy peripheral
|
25.0%
1/4
|
11.1%
1/9
|
20.0%
1/5
|
25.0%
3/12
|
44.4%
4/9
|
16.7%
1/6
|
12.5%
1/8
|
|
Nervous system disorders
Paraesthesia
|
50.0%
2/4
|
11.1%
1/9
|
20.0%
1/5
|
8.3%
1/12
|
0.00%
0/9
|
0.00%
0/6
|
25.0%
2/8
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4
|
55.6%
5/9
|
20.0%
1/5
|
8.3%
1/12
|
55.6%
5/9
|
50.0%
3/6
|
12.5%
1/8
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4
|
22.2%
2/9
|
0.00%
0/5
|
0.00%
0/12
|
11.1%
1/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
0.00%
0/12
|
22.2%
2/9
|
16.7%
1/6
|
0.00%
0/8
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
8.3%
1/12
|
11.1%
1/9
|
16.7%
1/6
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4
|
44.4%
4/9
|
20.0%
1/5
|
0.00%
0/12
|
33.3%
3/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4
|
11.1%
1/9
|
0.00%
0/5
|
0.00%
0/12
|
0.00%
0/9
|
16.7%
1/6
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
25.0%
1/4
|
22.2%
2/9
|
20.0%
1/5
|
8.3%
1/12
|
33.3%
3/9
|
0.00%
0/6
|
37.5%
3/8
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
25.0%
1/4
|
33.3%
3/9
|
0.00%
0/5
|
0.00%
0/12
|
11.1%
1/9
|
0.00%
0/6
|
12.5%
1/8
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
16.7%
2/12
|
22.2%
2/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
8.3%
1/12
|
22.2%
2/9
|
0.00%
0/6
|
12.5%
1/8
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
50.0%
2/4
|
11.1%
1/9
|
20.0%
1/5
|
0.00%
0/12
|
11.1%
1/9
|
16.7%
1/6
|
0.00%
0/8
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/4
|
0.00%
0/9
|
0.00%
0/5
|
0.00%
0/12
|
22.2%
2/9
|
16.7%
1/6
|
12.5%
1/8
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4
|
11.1%
1/9
|
0.00%
0/5
|
8.3%
1/12
|
0.00%
0/9
|
0.00%
0/6
|
25.0%
2/8
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4
|
11.1%
1/9
|
0.00%
0/5
|
8.3%
1/12
|
22.2%
2/9
|
16.7%
1/6
|
25.0%
2/8
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
25.0%
1/4
|
11.1%
1/9
|
0.00%
0/5
|
8.3%
1/12
|
0.00%
0/9
|
0.00%
0/6
|
0.00%
0/8
|
|
Vascular disorders
Hypertension
|
0.00%
0/4
|
11.1%
1/9
|
40.0%
2/5
|
0.00%
0/12
|
11.1%
1/9
|
0.00%
0/6
|
25.0%
2/8
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER