Trial Outcomes & Findings for Study of SU011248 in Patients With Advanced Kidney Cancer (NCT NCT00254540)
NCT ID: NCT00254540
Last Updated: 2010-02-23
Results Overview
Based on Extramural Review Committee's assessment. Number of subjects with objective response is defined as sum of the subjects with confirmed complete response (CR) and partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
Day 28 of Cycles 1-4
Results posted on
2010-02-23
Participant Flow
Participant milestones
| Measure |
First-line Treatment Population
SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
Pretreated Population
SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
26
|
|
Overall Study
COMPLETED
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
19
|
22
|
Reasons for withdrawal
| Measure |
First-line Treatment Population
SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
Pretreated Population
SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
7
|
|
Overall Study
Lack of Efficacy
|
13
|
13
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Laboratory Test Abnormality
|
0
|
1
|
Baseline Characteristics
Study of SU011248 in Patients With Advanced Kidney Cancer
Baseline characteristics by cohort
| Measure |
First-line Treatment Population
n=25 Participants
SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
Pretreated Population
n=26 Participants
SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
20-44 years
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Age, Customized
45-64 years
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Age, Customized
>=65 years
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
25 participants
n=5 Participants
|
26 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Score 0
|
20 participants
n=5 Participants
|
22 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Score 1
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 28 of Cycles 1-4Population: Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.
Based on Extramural Review Committee's assessment. Number of subjects with objective response is defined as sum of the subjects with confirmed complete response (CR) and partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study ≥4 weeks after initial documentation of response. CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Outcome measures
| Measure |
First-line Treatment Population
n=25 Participants
SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
Pretreated Population
n=26 Participants
SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
|---|---|---|
|
Number of Subjects With Objective Response
Total Number of Subjects with CR+PR
|
12 participants
|
12 participants
|
|
Number of Subjects With Objective Response
Complete Response (CR)
|
1 participants
|
0 participants
|
|
Number of Subjects With Objective Response
Partial Response (PR)
|
11 participants
|
12 participants
|
SECONDARY outcome
Timeframe: Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.Population: Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.
Progression-free survival (PFS) is defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD) or death.
Outcome measures
| Measure |
First-line Treatment Population
n=25 Participants
SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
Pretreated Population
n=26 Participants
SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
53.0 Weeks
Interval 3.9 to 130.0
|
46.0 Weeks
Interval 10.0 to 124.1
|
SECONDARY outcome
Timeframe: Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.Population: Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.
Time to tumor progression (TTP) is defined as the time from the date of first dose of study treatment to the date of the first documentation of progressive disease (PD).
Outcome measures
| Measure |
First-line Treatment Population
n=25 Participants
SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
Pretreated Population
n=26 Participants
SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
|---|---|---|
|
Time To Tumor Progression (TTP)
|
53.0 Weeks
Interval 3.9 to 130.0
|
46.0 Weeks
Interval 10.0 to 124.1
|
SECONDARY outcome
Timeframe: Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study. Up to 28 days after the last administration of the study drug.Population: Among Intent-To-Treat population, the number of subjects with objective tumor response based on investigator's assessment was 13 and 14 for the First-line treatment and the Pretreated populations, respectively.
Duration of response (DR) is defined as the period between the day of initial confirmation of complete response (CR) or partial response (PR) and the day of initial confirmation of progressive disease (PD) or death of any cause. For subjects who were not confirmed to have PD or death of any cause during the study (including 28 days after the completion of study treatment) or before the initiation of another antitumor therapy, DR was censored on the final confirmation of progression-free condition during the study.
Outcome measures
| Measure |
First-line Treatment Population
n=13 Participants
SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
Pretreated Population
n=14 Participants
SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
|---|---|---|
|
Duration of Response (DR)
|
111.6 Weeks
Interval 27.1 to 111.6
|
38.1 Weeks
Interval 18.7 to 102.1
|
SECONDARY outcome
Timeframe: Day 28 of Cycle 1-4, Day 28 of even cycles after Cycle 5, and at the end of the study.Population: Among Intent-To-Treat population, the number of subjects with objective tumor response based on investigator's assessment was 13 and 14 for the First-line treatment and the Pretreated populations, respectively.
Time to tumor response (TTR) is defined as the period between the day of initial study treatment and the day of initial confirmation of complete response (CR) or partial response (PR). CR = the disappearance of all target lesions. PR = a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Outcome measures
| Measure |
First-line Treatment Population
n=13 Participants
SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
Pretreated Population
n=14 Participants
SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
|---|---|---|
|
Time to Tumor Response (TTR)
|
10.0 Weeks
Interval 3.6 to 34.0
|
10.5 Weeks
Interval 3.7 to 38.6
|
SECONDARY outcome
Timeframe: once year. Up to 3 years after the completion of subject registration.Population: Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication.
Overall survival time is defined as the time from the date of first dose of study treatment to the date of the death due to any cause. For subjects whose death had not been confirmed, overall survival time was censored on the last date when the subject was known to be alive.
Outcome measures
| Measure |
First-line Treatment Population
n=25 Participants
SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
Pretreated Population
n=26 Participants
SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
|---|---|---|
|
Overall Survival Time
|
143.4 Weeks
Interval 13.7 to 149.3
|
141.0 Weeks
Interval 17.0 to 141.1
|
SECONDARY outcome
Timeframe: Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4Population: Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication. n=Number of subjects with analyzable data.
Change from Baseline: weighted health state index at each observation minus weighted health state index at baseline. The EQ-5D evaluates 5 dimensions of health. The subjects rates the severity of impairment for each dimensions on a 3-point scale (1 to 3). The digits for five dimensions were combined in a five-digit number describing the respondent's health state. Health states were converted into a weighted health state index (Range: 0 to 1). High score is indicating high health.
Outcome measures
| Measure |
First-line Treatment Population
n=25 Participants
SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
Pretreated Population
n=26 Participants
SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
|---|---|---|
|
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Health State Index Score
Cycle 3 Day 1 (n=17, 21)
|
0.0375 Scores on a scale
Standard Deviation 0.1509
|
0.0153 Scores on a scale
Standard Deviation 0.0911
|
|
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Health State Index Score
Cycle 2 Day 28 (n=20, 22)
|
-0.0946 Scores on a scale
Standard Deviation 0.2045
|
-0.0957 Scores on a scale
Standard Deviation 0.2127
|
|
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Health State Index Score
Cycle 1 Day 28 (n=25, 24)
|
-0.0937 Scores on a scale
Standard Deviation 0.2032
|
-0.0604 Scores on a scale
Standard Deviation 0.1753
|
|
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Health State Index Score
Cycle 2 Day 1 (n=20, 23)
|
-0.0067 Scores on a scale
Standard Deviation 0.1556
|
0.0513 Scores on a scale
Standard Deviation 0.0906
|
|
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Health State Index Score
Cycle 3 Day 28 (n=17, 21)
|
-0.1058 Scores on a scale
Standard Deviation 0.2058
|
-0.0735 Scores on a scale
Standard Deviation 0.2245
|
|
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Health State Index Score
Cycle 4 Day 1 (n=14, 19)
|
-0.0079 Scores on a scale
Standard Deviation 0.1856
|
0.0173 Scores on a scale
Standard Deviation 0.1105
|
|
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Health State Index Score
Cycle 4 Day 28 (n=14, 21)
|
-0.1573 Scores on a scale
Standard Deviation 0.1627
|
-0.0974 Scores on a scale
Standard Deviation 0.1979
|
SECONDARY outcome
Timeframe: Day 28 of Cycle 1; Days 1 and 28 of Cycles 2-4Population: Intent-to-Treat (ITT) population defined as all subjects enrolled in study that receive at least 1 dose of study medication. n=Number of subjects with analyzable data.
Change from Baseline: weighted health state VAS score at each observation minus weighted health state VAS score at baseline. The VAS is a self-completed scale designed to rate the subject's current health state from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Outcome measures
| Measure |
First-line Treatment Population
n=25 Participants
SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
Pretreated Population
n=26 Participants
SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
|---|---|---|
|
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Visual Analog Scale (VAS)
Cycle 1 Day 28 (n=25, 24)
|
-11.12 Scores on a scale
Standard Deviation 16.29
|
-10.54 Scores on a scale
Standard Deviation 15.97
|
|
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Visual Analog Scale (VAS)
Cycle 2 Day 1 (n=20, 23)
|
-2.10 Scores on a scale
Standard Deviation 13.49
|
4.17 Scores on a scale
Standard Deviation 13.12
|
|
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Visual Analog Scale (VAS)
Cycle 2 Day 28 (n=20, 22)
|
-7.85 Scores on a scale
Standard Deviation 18.31
|
-11.82 Scores on a scale
Standard Deviation 24.36
|
|
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Visual Analog Scale (VAS)
Cycle 3 Day 1 (n=17, 21)
|
2.71 Scores on a scale
Standard Deviation 12.88
|
1.10 Scores on a scale
Standard Deviation 9.14
|
|
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Visual Analog Scale (VAS)
Cycle 3 Day 28 (n=17, 21)
|
-12.35 Scores on a scale
Standard Deviation 23.69
|
-7.67 Scores on a scale
Standard Deviation 18.53
|
|
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Visual Analog Scale (VAS)
Cycle 4 Day 1 (n=14, 19)
|
-1.86 Scores on a scale
Standard Deviation 17.81
|
-0.79 Scores on a scale
Standard Deviation 19.81
|
|
Change From Baseline of European Quality of Life Questionnaire- 5 Dimensions(EQ-5D) Questionnaires Visual Analog Scale (VAS)
Cycle 4 Day 28 (n=14, 21)
|
-11.43 Scores on a scale
Standard Deviation 19.70
|
-6.43 Scores on a scale
Standard Deviation 19.48
|
SECONDARY outcome
Timeframe: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3Population: All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis. n=Number of subjects with analyzable data.
Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration
Outcome measures
| Measure |
First-line Treatment Population
n=25 Participants
SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
Pretreated Population
SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
|---|---|---|
|
Trough Plasma Concentration (Ctrough) of SU-011248 in First-line Treatment Population
Cycle 1 Day 14 (n=24)
|
81.60 ng/mL
Full Range 28.03 • Interval 34.3 to 163.0
|
—
|
|
Trough Plasma Concentration (Ctrough) of SU-011248 in First-line Treatment Population
Cycle 1 Day 28 (n=9)
|
71.00 ng/mL
Full Range 34.23 • Interval 43.3 to 130.0
|
—
|
|
Trough Plasma Concentration (Ctrough) of SU-011248 in First-line Treatment Population
Cycle 2 Day 1 (n=6)
|
1.24 ng/mL
Full Range 1.98 • Interval 0.2 to 3.85
|
—
|
|
Trough Plasma Concentration (Ctrough) of SU-011248 in First-line Treatment Population
Cycle 2 Day 28 (n=4)
|
61.45 ng/mL
Full Range 17.65 • Interval 55.3 to 102.0
|
—
|
|
Trough Plasma Concentration (Ctrough) of SU-011248 in First-line Treatment Population
Cycle 3 Day 28 (n=4)
|
71.30 ng/mL
Full Range 22.97 • Interval 49.7 to 84.3
|
—
|
SECONDARY outcome
Timeframe: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3Population: All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis. n=Number of subjects with analyzable data. Descriptive statistics on "Cycle 2 Day 1" and "Cycle 3 Day 28" were not calculated because number of subjects with analyzable data was less than 3.
Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration.
Outcome measures
| Measure |
First-line Treatment Population
n=26 Participants
SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
Pretreated Population
SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
|---|---|---|
|
Trough Plasma Concentration (Ctrough) of SU-011248 in Pretreated Population
Cycle 1 Day 14 (n=13)
|
85.90 ng/mL
Interval 69.9 to 119.0
|
—
|
|
Trough Plasma Concentration (Ctrough) of SU-011248 in Pretreated Population
Cycle 1 Day 28 (n=4)
|
75.00 ng/mL
Interval 56.6 to 151.0
|
—
|
|
Trough Plasma Concentration (Ctrough) of SU-011248 in Pretreated Population
Cycle 2 Day 28 (n=3)
|
57.70 ng/mL
Interval 47.0 to 61.3
|
—
|
SECONDARY outcome
Timeframe: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3Population: All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis. n=Number of subjects with analyzable data.
SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration
Outcome measures
| Measure |
First-line Treatment Population
n=25 Participants
SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
Pretreated Population
SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
|---|---|---|
|
Trough Plasma Concentration (Ctrough) of SU-012662 in First-line Treatment Population
Cycle 1 Day 14 (n=24)
|
36.10 ng/mL
Full Range 20.65 • Interval 12.4 to 96.4
|
—
|
|
Trough Plasma Concentration (Ctrough) of SU-012662 in First-line Treatment Population
Cycle 1 Day 28 (n=9)
|
50.50 ng/mL
Full Range 19.65 • Interval 12.7 to 66.2
|
—
|
|
Trough Plasma Concentration (Ctrough) of SU-012662 in First-line Treatment Population
Cycle 2 Day 1 (n=6)
|
2.14 ng/mL
Full Range 1.21 • Interval 0.66 to 3.91
|
—
|
|
Trough Plasma Concentration (Ctrough) of SU-012662 in First-line Treatment Population
Cycle 2 Day 28 (n=4)
|
35.15 ng/mL
Full Range 7.17 • Interval 21.0 to 35.7
|
—
|
|
Trough Plasma Concentration (Ctrough) of SU-012662 in First-line Treatment Population
Cycle 3 Day 28 (n=4)
|
33.55 ng/mL
Full Range 13.81 • Interval 20.4 to 53.0
|
—
|
SECONDARY outcome
Timeframe: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3Population: All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis. Descriptive statistics on "Cycle 2 Day 1" and "Cycle 3 Day 28" were not calculated because number of subjects with analyzable data was less than 3. n=Number of subjects with analyzable data.
SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration
Outcome measures
| Measure |
First-line Treatment Population
n=26 Participants
SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
Pretreated Population
SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
|---|---|---|
|
Trough Plasma Concentration (Ctrough) of SU-012662 in Pretreated Population
Cycle 1 Day 14 (n=13)
|
31.60 ng/mL
Interval 21.1 to 57.3
|
—
|
|
Trough Plasma Concentration (Ctrough) of SU-012662 in Pretreated Population
Cycle 1 Day 28 (n=4)
|
25.70 ng/mL
Interval 16.1 to 39.3
|
—
|
|
Trough Plasma Concentration (Ctrough) of SU-012662 in Pretreated Population
Cycle 2 Day 28 (n=3)
|
17.50 ng/mL
Interval 13.9 to 29.3
|
—
|
SECONDARY outcome
Timeframe: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3Population: All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis. n=Number of subjects with analyzable data.
SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration. The Ctrough for total drug (SU-011248+SU-012662) was calculated as the mean of the Ctrough of total drug from each individual subject.
Outcome measures
| Measure |
First-line Treatment Population
n=25 Participants
SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
Pretreated Population
SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
|---|---|---|
|
Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in First-line Treatment Population
Cycle 1 Day 14 (n=24)
|
130.30 ng/mL
Full Range 45.31 • Interval 50.3 to 259.4
|
—
|
|
Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in First-line Treatment Population
Cycle 1 Day 28 (n=9)
|
137.20 ng/mL
Full Range 48.85 • Interval 63.4 to 180.5
|
—
|
|
Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in First-line Treatment Population
Cycle 2 Day 1 (n=6)
|
3.67 ng/mL
Full Range 2.31 • Interval 0.86 to 7.76
|
—
|
|
Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in First-line Treatment Population
Cycle 2 Day 28 (n=4)
|
93.95 ng/mL
Full Range 24.17 • Interval 82.4 to 136.9
|
—
|
|
Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in First-line Treatment Population
Cycle 3 Day 28 (n=4)
|
114.70 ng/mL
Full Range 22.83 • Interval 70.1 to 117.6
|
—
|
SECONDARY outcome
Timeframe: Days 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3Population: All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacokinetic analysis. Descriptive statistics on "Cycle 2 Day 1" and "Cycle 3 Day 28" were not calculated because number of subjects with analyzable data was less than 3. n=Number of subjects with analyzable data.
SU-012662 is a metabolite of SU-011248. Trough Plasma Concentration (Ctrough) means the concentration prior to study drug administration. The Ctrough for total drug (SU011248+SU012662) was calculated as the mean of the Ctrough of total drug from each individual subject.
Outcome measures
| Measure |
First-line Treatment Population
n=26 Participants
SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
Pretreated Population
SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
|---|---|---|
|
Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in Pretreated Population
Cycle 1 Day 14 (n=13)
|
115.10 ng/mL
Interval 96.7 to 176.3
|
—
|
|
Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in Pretreated Population
Cycle 1 Day 28 (n=4)
|
100.70 ng/mL
Interval 72.7 to 190.3
|
—
|
|
Trough Plasma Concentration (Ctrough) of SU-011248+SU-012662 in Pretreated Population
Cycle 2 Day 28 (n=3)
|
75.20 ng/mL
Interval 60.9 to 90.6
|
—
|
SECONDARY outcome
Timeframe: Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3Population: All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacodynamic analysis. n=Number of subjects with analyzable data.
Plasma concentrations of potential pharmacodynamic markers; Vascular Endothelial Growth Factor (VEGF)
Outcome measures
| Measure |
First-line Treatment Population
n=51 Participants
SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
Pretreated Population
SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
|---|---|---|
|
Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)
Cycle 1 Day 1 (n=51)
|
54.90 pg/mL
Full Range 84.99 • Interval 19.7 to 396.5
|
—
|
|
Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)
Cycle 1 Day 14 (n=42)
|
186.60 pg/mL
Full Range 267.19 • Interval 60.7 to 1100.5
|
—
|
|
Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)
Cycle 1 Day 28 (n=16)
|
259.90 pg/mL
Full Range 263.44 • Interval 101.0 to 977.5
|
—
|
|
Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)
Cycle 2 Day 1 (n=18)
|
57.35 pg/mL
Full Range 94.18 • Interval 21.8 to 335.8
|
—
|
|
Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)
Cycle 2 Day 28 (n=8)
|
264.75 pg/mL
Full Range 115.19 • Interval 120.5 to 474.9
|
—
|
|
Plasma Concentrations of Vascular Endothelial Growth Factor (VEGF)
Cycle 3 Day 28 (n=6)
|
194.15 pg/mL
Full Range 111.20 • Interval 94.1 to 503.0
|
—
|
SECONDARY outcome
Timeframe: Days 1, 14 and 28 of Cycle 1; Days 1 and 28 of Cycle 2; Day 28 of Cycle 3Population: All enrolled subjects who received at least 1 dose of study medication and who had at least 1 plasma concentration data for Pharmacodynamic analysis. n=Number of subjects with analyzable data.
Plasma concentrations of potential pharmacodynamic markers; Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)
Outcome measures
| Measure |
First-line Treatment Population
n=51 Participants
SU-011248 capsule:
Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
Pretreated Population
SU-011248 capsule:
Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria.
|
|---|---|---|
|
Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)
Cycle 1 Day 1 (n=51)
|
9311.00 pg/mL
Full Range 1630.73 • Interval 5544.0 to 11975.0
|
—
|
|
Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)
Cycle 1 Day 14 (n=42)
|
4673.50 pg/mL
Full Range 1402.34 • Interval 2647.0 to 8610.0
|
—
|
|
Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)
Cycle 1 Day 28 (n=16)
|
3650.00 pg/mL
Full Range 1442.21 • Interval 2573.0 to 6959.0
|
—
|
|
Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)
Cycle 2 Day 1 (n=18)
|
7276.50 pg/mL
Full Range 1756.36 • Interval 4226.0 to 9253.0
|
—
|
|
Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)
Cycle 2 Day 28 (n=8)
|
3535.00 pg/mL
Full Range 927.90 • Interval 3093.0 to 5337.0
|
—
|
|
Plasma Concentrations of Soluble Vascular Endothelial Growth Factor Type 2 Receptors (sVEGFR2)
Cycle 3 Day 28 (n=6)
|
3312.50 pg/mL
Full Range 831.61 • Interval 1952.0 to 4742.0
|
—
|
Adverse Events
Overall
Serious events: 28 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Overall
n=51 participants at risk
SU-011248 Capsule:First-line Treatment population plus Pretreated population
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.9%
2/51
|
|
Cardiac disorders
Atrial fibrillation
|
3.9%
2/51
|
|
Cardiac disorders
Myocardial infarction
|
2.0%
1/51
|
|
Cardiac disorders
Sick sinus syndrome
|
2.0%
1/51
|
|
Endocrine disorders
Hypothyroidism
|
3.9%
2/51
|
|
Endocrine disorders
Thyroiditis
|
2.0%
1/51
|
|
Gastrointestinal disorders
Anal fistula
|
2.0%
1/51
|
|
Gastrointestinal disorders
Anal ulcer
|
2.0%
1/51
|
|
Gastrointestinal disorders
Ascites
|
2.0%
1/51
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/51
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
2.0%
1/51
|
|
Gastrointestinal disorders
Melaena
|
2.0%
1/51
|
|
Gastrointestinal disorders
Nausea
|
7.8%
4/51
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.0%
1/51
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
3/51
|
|
General disorders
Fatigue
|
5.9%
3/51
|
|
General disorders
Malaise
|
3.9%
2/51
|
|
General disorders
Pyrexia
|
2.0%
1/51
|
|
Hepatobiliary disorders
Bile duct stone
|
2.0%
1/51
|
|
Hepatobiliary disorders
Cholecystitis
|
2.0%
1/51
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
2.0%
1/51
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.0%
1/51
|
|
Infections and infestations
Sepsis
|
2.0%
1/51
|
|
Investigations
Alanine aminotransferase increased
|
3.9%
2/51
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
3/51
|
|
Investigations
Blood alkaline phosphatase increased
|
3.9%
2/51
|
|
Investigations
Blood bilirubin increased
|
2.0%
1/51
|
|
Investigations
Ejection fraction decreased
|
2.0%
1/51
|
|
Investigations
Neutrophil count decreased
|
3.9%
2/51
|
|
Investigations
Platelet count decreased
|
9.8%
5/51
|
|
Investigations
White blood cell count decreased
|
3.9%
2/51
|
|
Metabolism and nutrition disorders
Anorexia
|
7.8%
4/51
|
|
Metabolism and nutrition disorders
Dehydration
|
9.8%
5/51
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
2.0%
1/51
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.0%
1/51
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.0%
1/51
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.0%
1/51
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
2.0%
1/51
|
|
Nervous system disorders
Headache
|
2.0%
1/51
|
|
Renal and urinary disorders
Proteinuria
|
2.0%
1/51
|
|
Renal and urinary disorders
Renal failure acute
|
2.0%
1/51
|
|
Renal and urinary disorders
Renal impairment
|
2.0%
1/51
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
1/51
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
1/51
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
2.0%
1/51
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/51
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.0%
1/51
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/51
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
2.0%
1/51
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
2.0%
1/51
|
|
Vascular disorders
Hypertension
|
2.0%
1/51
|
Other adverse events
| Measure |
Overall
n=51 participants at risk
SU-011248 Capsule:First-line Treatment population plus Pretreated population
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
29.4%
15/51
|
|
Cardiac disorders
Palpitations
|
9.8%
5/51
|
|
Endocrine disorders
Hypothyroidism
|
45.1%
23/51
|
|
Eye disorders
Conjunctivitis
|
7.8%
4/51
|
|
Eye disorders
Erythema of eyelid
|
5.9%
3/51
|
|
Eye disorders
Eyelid oedema
|
25.5%
13/51
|
|
Gastrointestinal disorders
Abdominal distension
|
7.8%
4/51
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.8%
6/51
|
|
Gastrointestinal disorders
Anal erosion
|
7.8%
4/51
|
|
Gastrointestinal disorders
Cheilitis
|
23.5%
12/51
|
|
Gastrointestinal disorders
Constipation
|
21.6%
11/51
|
|
Gastrointestinal disorders
Diarrhoea
|
56.9%
29/51
|
|
Gastrointestinal disorders
Dyspepsia
|
23.5%
12/51
|
|
Gastrointestinal disorders
Gastritis
|
5.9%
3/51
|
|
Gastrointestinal disorders
Gingival bleeding
|
5.9%
3/51
|
|
Gastrointestinal disorders
Gingival swelling
|
5.9%
3/51
|
|
Gastrointestinal disorders
Gingivitis
|
13.7%
7/51
|
|
Gastrointestinal disorders
Glossitis
|
7.8%
4/51
|
|
Gastrointestinal disorders
Haemorrhoids
|
9.8%
5/51
|
|
Gastrointestinal disorders
Lip dry
|
5.9%
3/51
|
|
Gastrointestinal disorders
Melaena
|
5.9%
3/51
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
5.9%
3/51
|
|
Gastrointestinal disorders
Nausea
|
49.0%
25/51
|
|
Gastrointestinal disorders
Periodontitis
|
5.9%
3/51
|
|
Gastrointestinal disorders
Periproctitis
|
11.8%
6/51
|
|
Gastrointestinal disorders
Stomach discomfort
|
17.6%
9/51
|
|
Gastrointestinal disorders
Stomatitis
|
51.0%
26/51
|
|
Gastrointestinal disorders
Toothache
|
7.8%
4/51
|
|
Gastrointestinal disorders
Vomiting
|
29.4%
15/51
|
|
General disorders
Chest pain
|
5.9%
3/51
|
|
General disorders
Chills
|
9.8%
5/51
|
|
General disorders
Face oedema
|
47.1%
24/51
|
|
General disorders
Fatigue
|
66.7%
34/51
|
|
General disorders
Malaise
|
37.3%
19/51
|
|
General disorders
Oedema
|
15.7%
8/51
|
|
General disorders
Oedema peripheral
|
41.2%
21/51
|
|
General disorders
Pyrexia
|
58.8%
30/51
|
|
General disorders
Thirst
|
5.9%
3/51
|
|
Infections and infestations
Nasopharyngitis
|
47.1%
24/51
|
|
Infections and infestations
Pharyngitis
|
5.9%
3/51
|
|
Investigations
Alanine aminotransferase increased
|
51.0%
26/51
|
|
Investigations
Aspartate aminotransferase increased
|
68.6%
35/51
|
|
Investigations
Blood albumin decreased
|
35.3%
18/51
|
|
Investigations
Blood alkaline phosphatase increased
|
35.3%
18/51
|
|
Investigations
Blood amylase increased
|
51.0%
26/51
|
|
Investigations
Blood bilirubin increased
|
31.4%
16/51
|
|
Investigations
Blood calcium decreased
|
23.5%
12/51
|
|
Investigations
Blood creatine phosphokinase increased
|
7.8%
4/51
|
|
Investigations
Blood creatinine increased
|
56.9%
29/51
|
|
Investigations
Blood glucose increased
|
9.8%
5/51
|
|
Investigations
Blood lactate dehydrogenase increased
|
70.6%
36/51
|
|
Investigations
Blood phosphorus decreased
|
27.5%
14/51
|
|
Investigations
Blood potassium increased
|
5.9%
3/51
|
|
Investigations
Blood pressure increased
|
7.8%
4/51
|
|
Investigations
Blood sodium decreased
|
9.8%
5/51
|
|
Investigations
Blood thyroid stimulating hormone increased
|
13.7%
7/51
|
|
Investigations
Blood urea increased
|
15.7%
8/51
|
|
Investigations
Blood uric acid increased
|
15.7%
8/51
|
|
Investigations
Blood urine present
|
7.8%
4/51
|
|
Investigations
C-reactive protein increased
|
19.6%
10/51
|
|
Investigations
Gamma-glutamyltransferase increased
|
13.7%
7/51
|
|
Investigations
Haemoglobin decreased
|
49.0%
25/51
|
|
Investigations
Lipase increased
|
70.6%
36/51
|
|
Investigations
Lymphocyte count decreased
|
70.6%
36/51
|
|
Investigations
Neutrophil count decreased
|
80.4%
41/51
|
|
Investigations
Platelet count decreased
|
92.2%
47/51
|
|
Investigations
Protein total decreased
|
21.6%
11/51
|
|
Investigations
Red blood cell count decreased
|
5.9%
3/51
|
|
Investigations
Weight decreased
|
17.6%
9/51
|
|
Investigations
Weight increased
|
11.8%
6/51
|
|
Investigations
White blood cell count decreased
|
86.3%
44/51
|
|
Metabolism and nutrition disorders
Anorexia
|
70.6%
36/51
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.8%
6/51
|
|
Metabolism and nutrition disorders
Dehydration
|
11.8%
6/51
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.9%
3/51
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
7.8%
4/51
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
17.6%
9/51
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
7.8%
4/51
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.9%
3/51
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
9.8%
5/51
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
15.7%
8/51
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
7.8%
4/51
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.9%
3/51
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
23.5%
12/51
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.9%
3/51
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
7.8%
4/51
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
15.7%
8/51
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
17.6%
9/51
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
5.9%
3/51
|
|
Nervous system disorders
Dizziness
|
17.6%
9/51
|
|
Nervous system disorders
Dysgeusia
|
54.9%
28/51
|
|
Nervous system disorders
Headache
|
25.5%
13/51
|
|
Nervous system disorders
Hypoaesthesia
|
7.8%
4/51
|
|
Nervous system disorders
Hypogeusia
|
13.7%
7/51
|
|
Psychiatric disorders
Insomnia
|
11.8%
6/51
|
|
Renal and urinary disorders
Chromaturia
|
5.9%
3/51
|
|
Renal and urinary disorders
Haematuria
|
5.9%
3/51
|
|
Renal and urinary disorders
Proteinuria
|
17.6%
9/51
|
|
Reproductive system and breast disorders
Scrotal ulcer
|
5.9%
3/51
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.6%
10/51
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
19.6%
10/51
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.7%
8/51
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
33.3%
17/51
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
5.9%
3/51
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
9.8%
5/51
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.8%
5/51
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
15.7%
8/51
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
5.9%
3/51
|
|
Skin and subcutaneous tissue disorders
Achromotrichia acquired
|
5.9%
3/51
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
15.7%
8/51
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
9.8%
5/51
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
15.7%
8/51
|
|
Skin and subcutaneous tissue disorders
Eczema
|
7.8%
4/51
|
|
Skin and subcutaneous tissue disorders
Erythema
|
15.7%
8/51
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
15.7%
8/51
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
7.8%
4/51
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
52.9%
27/51
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.8%
6/51
|
|
Skin and subcutaneous tissue disorders
Purpura
|
9.8%
5/51
|
|
Skin and subcutaneous tissue disorders
Rash
|
56.9%
29/51
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
72.5%
37/51
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
5.9%
3/51
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
13.7%
7/51
|
|
Skin and subcutaneous tissue disorders
Yellow skin
|
9.8%
5/51
|
|
Vascular disorders
Haemorrhage
|
5.9%
3/51
|
|
Vascular disorders
Hypertension
|
60.8%
31/51
|
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 info other than study results.
- Publication restrictions are in place
Restriction type: OTHER