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Trial record 1 of 1 for:    "Triple-Receptor Negative Breast Cancer" | "Docetaxel"
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Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT00246571
Recruitment Status : Completed
First Posted : October 31, 2005
Results First Posted : June 27, 2011
Last Update Posted : July 12, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Neoplasms
Interventions Drug: SU011248
Drug: Chemotherapy
Enrollment 217
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sunitinib Standard of Care
Hide Arm/Group Description SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities. One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 milligrams per square meter (mg/m^2) twice daily (BID) Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid intravenous (IV) infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If Response Evaluation Criteria in Solid Tumors (RECIST) defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
Period Title: Overall Study
Started 113 104
Randomized But Not Treated 3 1
Completed 0 0
Not Completed 113 104
Reason Not Completed
Adverse Event             7             0
Protocol Violation             0             1
Withdrawal by Subject             2             3
Lack of Efficacy             84             21
Death             17             3
Sponsor             0             1
Did not meet entrance criteria             2             1
Laboratory abnormalities             1             0
Crossover participants             0             74
Arm/Group Title Sunitinib Standard of Care Total
Hide Arm/Group Description SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities. One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles. Total of all reporting groups
Overall Number of Baseline Participants 113 104 217
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 113 participants 104 participants 217 participants
Less than 65 years 103 90 193
Greater than or equal to 65 years 10 14 24
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 113 participants 104 participants 217 participants
Female
113
 100.0%
104
 100.0%
217
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Progression-Free Survival (PFS)
Hide Description Time in months from start of study treatment to first documentation of objective tumor progression (per RECIST) or death due to any cause. PFS was calculated as (first event date minus first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Time Frame Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) population: all participants who were randomized.
Arm/Group Title Sunitinib Standard of Care
Hide Arm/Group Description:
SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
Overall Number of Participants Analyzed 113 104
Median (95% Confidence Interval)
Unit of Measure: Months
Core radiology laboratory assessment
2.0
(1.5 to 2.8)
2.7
(1.7 to 2.8)
Investigator's assessment
1.7
(1.5 to 2.6)
2.5
(1.4 to 2.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib, Standard of Care
Comments For core radiology laboratory assessment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8885
Comments One-sided log-rank test stratified for the number of prior chemotherapy regiments (1 versus more than 1), which is from the interactive voice response system (IVRS).
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.2030
Confidence Interval (2-Sided) 95%
0.8889 to 1.6280
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sunitinib, Standard of Care
Comments For investigator's assessment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8472
Comments One-sided log-rank test stratified for the number of prior chemotherapy regiments (1 versus more than 1), which is from IVRS.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.1598
Confidence Interval (2-Sided) 95%
0.8703 to 1.5457
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Proportion of Participants With Objective Response
Hide Description Objective response based assessment of confirmed response (CR) or confirmed partial response (PR) according to RECIST. CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with a greater than or equal to (≥) 30% decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD.
Time Frame Baseline until response or disease progression (up to 3 years from first dose)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Sunitinib Standard of Care
Hide Arm/Group Description:
SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
Overall Number of Participants Analyzed 113 104
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Core radiology laboratory assessment
2.7
(0.6 to 7.6)
6.7
(2.7 to 13.4)
Investigator's assessment
8.8
(4.3 to 15.7)
11.5
(6.1 to 19.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib, Standard of Care
Comments Core radiology laboratory assessment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9624
Comments The stratified analysis was from Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factor, the number of prior chemotherapy regimens (1 versus more than 1), which is from IVRS.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.38
Confidence Interval (2-Sided) 95%
0.06 to 1.71
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Sunitinib, Standard of Care
Comments Investigator's assessment
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8140
Comments The stratified analysis was from Cochran-Mantel-Haenszel (CMH) test stratified by randomization stratification factor, the number of prior chemotherapy regimens (1 versus more than 1), which is from IVRS.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.74
Confidence Interval (2-Sided) 95%
0.27 to 1.98
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Duration of Response (DR)
Hide Description Time in months from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Time Frame Time from first response to disease progression up to 3 years from first dose
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Sunitinib Standard of Care
Hide Arm/Group Description:
SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
Overall Number of Participants Analyzed 113 104
Median (95% Confidence Interval)
Unit of Measure: months
Core radiology assessment (n=3,7)
3.0
(2.8 to 7.3)
NA [1] 
(5.2 to NA)
Investigator's assessment (n=10,12)
3.6
(2.8 to 6.2)
4.6
(3.1 to 11.2)
[1]
NA=not available. The upper bound of the confidence interval could not be estimated because there were not enough data relative to the possible number of data points to estimate the percentiles.
4.Secondary Outcome
Title Survival Probability at 1 Year
Hide Description Probability that the participants will survive at end of 1 year from the first dose of study treatment. Calculated using data collected from baseline until death (up to 3 years after first dose of study medication). Probability calculated from Kaplan-Meier estimate.
Time Frame Baseline until death (up to 3 years after first dose of study medication)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Sunitinib Standard of Care
Hide Arm/Group Description:
SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
Overall Number of Participants Analyzed 113 104
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: ratio
0.376
(0.285 to 0.466)
0.446
(0.346 to 0.541)
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description Time in months from the date of randomization to date of death due to any cause. OS was calculated as (date of death minus randomization date plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Time Frame Baseline until death (up to 3 years after first dose of study medication)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Sunitinib Standard of Care
Hide Arm/Group Description:
SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
Overall Number of Participants Analyzed 113 104
Median (95% Confidence Interval)
Unit of Measure: months
9.4
(5.8 to 11.2)
10.5
(8.5 to 13.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sunitinib, Standard of Care
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8394
Comments One-sided log rank test stratified for the number of prior chemotherapy regimens (1 versus more than 1), which is from IVRS.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.1599
Confidence Interval (2-Sided) 95%
0.8648 to 1.5558
Estimation Comments Hazard ratio for sunitinib versus standard of care.
6.Secondary Outcome
Title Health Related Quality of Life (HRQoL) and Disease Related Symptoms as Measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (EORTC-QLQ-C30)
Hide Description EORTC QLQ-C30: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much; global/QoL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Time Frame Day 1, Cycle 1; Day 1, odd number cycles; and end of treatment (EOT)/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
This participant-reported outcome was not analyzed for this report because the study did not meet its primary endpoint.
Arm/Group Title Sunitinib Standard of Care
Hide Arm/Group Description:
SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title HRQoL and Disease Related Symptoms as Measured by EORTC-QLQ-C30 Breast Cancer Module (BR23) Score
Hide Description BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.
Time Frame Day 1, Cycle 1; Day 1, odd number cycles; and EOT/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
This participant-reported outcome was not analyzed for this report because the study did not meet its primary endpoint.
Arm/Group Title Sunitinib Standard of Care
Hide Arm/Group Description:
SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Observed Plasma Trough Concentrations (Ctrough) of Sunitinib
Hide Description [Not Specified]
Time Frame Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. n = number of participants with available data for those time points.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1, Day 1 (n=54) 0.12  (0.90)
Cycle 1, Day 15 (n=44) 65.53  (30.64)
Cycle 2, Day 1 (n=42) 62.09  (37.02)
Cycle 2, Day 15 (n=33) 58.20  (29.67)
Cycle 3, Day 1 (n=26) 50.03  (35.56)
Cycle 3, Day 15 (n=21) 64.61  (28.75)
Cycle 4, Day 1 (n=18) 51.25  (32.88)
Cycle 5, Day 1 (n=12) 48.07  (24.74)
Cycle 7, Day 1 (n=6) 42.23  (22.88)
9.Secondary Outcome
Title Ctrough of SU012662 (Metabolite of Sunitinib)
Hide Description [Not Specified]
Time Frame Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. n = number of participants with available data for those time points.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1, Day 1 (n=54) 0.02  (0.16)
Cycle 1, Day 15 (n=44) 29.4  (10.99)
Cycle 2, Day 1 (n=42) 32.3  (17.21)
Cycle 2, Day 15 (n=33) 33.4  (20.75)
Cycle 3, Day 1 (n=26) 28.5  (21.91)
Cycle 3, Day 15 (n=21) 40.4  (15.33)
Cycle 4, Day 1 (n=18) 30.9  (19.06)
Cycle 5, Day 1 (n=12) 36.1  (22.01)
Cycle 7, Day 1 (n=6) 21.3  (5.06)
10.Secondary Outcome
Title Ctrough of Total Drug (Sunitinib + SU012662)
Hide Description [Not Specified]
Time Frame Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. n = number of participants with available data for those time points.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1, Day 1 (n=54) 0.14  (1.05)
Cycle 1, Day 15 (n=44) 94.9  (38.43)
Cycle 2, Day 1 (n=42) 94.4  (51.24)
Cycle 2, Day 15 (n=33) 91.6  (46.27)
Cycle 3, Day 1 (n=26) 78.6  (53.15)
Cycle 3, Day 15 (n=21) 105  (39.99)
Cycle 4, Day 1 (n=18) 82.2  (48.56)
Cycle 5, Day 1 (n=12) 84.2  (42.66)
Cycle 7, Day 1 (n=6) 63.6  (24.64)
11.Secondary Outcome
Title Dose-corrected Ctrough of Sunitinib
Hide Description Ctrough = plasma concentration of sunitinib prior to study drug administration, dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.
Time Frame Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. n = number of participants with available data for those time points.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
Overall Number of Participants Analyzed 44
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1, Day 1 (n=ND) NA [1]   (NA)
Cycle 1, Day 15 (n=44) 67.5  (28.78)
Cycle 2, Day 1 (n=42) 73.4  (29.70)
Cycle 2, Day 15 (n=33) 69.8  (32.67)
Cycle 3, Day 1 (n=26) 69.3  (30.08)
Cycle 3, Day 15 (n=21) 65.3  (29.72)
Cycle 4, Day 1 (n=18) 68.7  (34.28)
Cycle 5, Day 1 (n=12) 58.4  (27.14)
Cycle 7, Day 1 (n=6) 64.0  (46.99)
[1]
NA=not available. No participants analyzed
12.Secondary Outcome
Title Dose-corrected Ctrough of SU012662 (Metabolite of Sunitinib)
Hide Description Ctrough = plasma concentration of SU012662 prior to study drug administration, dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.
Time Frame Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. n = number of participants with available data for those time points.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
Overall Number of Participants Analyzed 54
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1, Day 1 (n=ND) NA [1]   (NA)
Cycle 1, Day 15 (n=44) 29.9  (10.14)
Cycle 2, Day 1 (n=42) 37.2  (13.33)
Cycle 2, Day 15 (n=33) 37.3  (20.72)
Cycle 3, Day 1 (n=26) 39.8  (21.58)
Cycle 3, Day 15 (n=21) 40.1  (14.55)
Cycle 4, Day 1 (n=18) 38.7  (17.58)
Cycle 5, Day 1 (n=12) 41.9  (19.95)
Cycle 7, Day 1 (n=6) 28.6  (7.86)
[1]
Participants not analyzed
13.Secondary Outcome
Title Dose-corrected Ctrough of Total Drug (Sunitinib + SU012662)
Hide Description Ctrough = plasma concentration of total drug (Sunitinib + SU012662) prior to study drug administration dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.
Time Frame Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. n = number of participants with available data for those time points.
Arm/Group Title Sunitinib
Hide Arm/Group Description:
SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
Overall Number of Participants Analyzed 44
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1, Day 1 (n=ND) NA [1]   (NA)
Cycle 1, Day 15 (n=44) 97.4  (35.09)
Cycle 2, Day 1 (n=42) 111  (38.18)
Cycle 2, Day 15 (n=33) 107  (48.08)
Cycle 3, Day 1 (n=26) 109  (44.98)
Cycle 3, Day 15 (n=21) 105  (39.64)
Cycle 4, Day 1 (n=18) 107  (46.13)
Cycle 5, Day 1 (n=12) 100  (39.32)
Cycle 7, Day 1 (n=6) 92.5  (52.82)
[1]
Participants not analyzed
14.Secondary Outcome
Title Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2)
Hide Description Plasma concentrations of sVEGFR2 were examined as a potential pharmacodynamic marker
Time Frame Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. This outcome measure was not analyzed.
Arm/Group Title Sunitinib Standard of Care
Hide Arm/Group Description:
SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (sVEGFR3)
Hide Description Plasma concentrations of sVEGFR3 were examined as a potential pharmacodynamic marker
Time Frame Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. n = participants with available data at that time point.
Arm/Group Title Sunitinib Standard of Care
Hide Arm/Group Description:
SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
Overall Number of Participants Analyzed 83 64
Mean (Standard Deviation)
Unit of Measure: pg/mL
Cycle 1 Day 1 (n=83, 64) 24124.82  (13258.718) 25857.19  (11164.091)
Cycle 2 Day 1 (n=66, 48) 16299.70  (13603.540) 24515.83  (11335.285)
Cycle 3 Day 1 (n=48, 35) 14459.38  (9830.743) 29034.86  (13106.527)
Cycle 4 Day 1 (n=32, 27) 13702.81  (13625.710) 27929.63  (11051.566)
Cycle 5 Day 1 (n=28, 20) 16345.36  (19710.783) 32949  (13113.402)
Cycle 7 Day 1 (n=9, 9) 24795.56  (44213.992) 32004.44  (15886.981)
End Of Treatment (n=48, 10) 26746.46  (45358.590) 29194  (16686.909)
16.Secondary Outcome
Title Plasma Concentration of Soluble Vascular Endothelial Growth Factor A (sVEGF-A)
Hide Description Plasma concentrations of sVEGF-A were examined as a potential pharmacodynamic marker
Time Frame Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. n = participants with available data at that time point.
Arm/Group Title Sunitinib Standard of Care
Hide Arm/Group Description:
SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
Overall Number of Participants Analyzed 83 66
Mean (Standard Deviation)
Unit of Measure: pg/mL
Cycle 1 Day 1 (n=83, 66) 152.28  (189.204) 151.49  (170.322)
Cycle 2 Day 1 (n=67, 50) 455.17  (704.062) 170.43  (174.635)
Cycle 3 Day 1 (n=49, 37) 265.56  (235.166) 129.31  (140.943)
Cycle 4 Day 1 (n=33, 28) 274.94  (226.763) 129.88  (131.303)
Cycle 5 Day 1 (n=28, 20) 324.09  (281.943) 126.97  (135.604)
Cycle 7 Day 1 (n=9, 10) 241.78  (148.593) 115.58  (96.101)
End Of Treatment (n=49, 12) 294.66  (675.063) 94.76  (89.677)
17.Secondary Outcome
Title Plasma Concentration of Soluble Placental Growth Factor (sPlGF)
Hide Description Plasma concentrations of sPlGF were examined as a potential pharmacodynamic marker
Time Frame Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. n = participants with available data at that time point.
Arm/Group Title Sunitinib Standard of Care
Hide Arm/Group Description:
SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
Overall Number of Participants Analyzed 15 11
Mean (Standard Deviation)
Unit of Measure: pg/mL
Cycle 1 Day 1 (n=15, 11) 36.96  (13.677) 37.23  (7.007)
Cycle 2 Day 1 (n=11, 9) 168.05  (168.643) 36.24  (5.778)
Cycle 3 Day 1 (n=5, 4) 72.16  (30.436) 40.08  (11.539)
Cycle 4 Day 1 (n=2, 3) 144.60  (4.384) 33.23  (6.170)
Cycle 5 Day 1 (n=1, 3) 118.30  (0) 51.83  (10.385)
Cycle 7 Day 1 (n=1, 1) 176.60  (0) 38.50  (0)
End Of Treatment (n=5, 0) 87.54  (75.665) 0  (0)
18.Secondary Outcome
Title Plasma Concentration of Soluble Kinase Insert Domain for Tyrosine (sKIT), a Stem Cell Factor Receptor
Hide Description Plasma concentrations of sKIT were examined as a potential pharmacodynamic marker
Time Frame Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. n = participants with available data at that time point.
Arm/Group Title Sunitinib Standard of Care
Hide Arm/Group Description:
SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
Overall Number of Participants Analyzed 83 64
Mean (Standard Deviation)
Unit of Measure: pg/mL
Cycle 1 Day 1 (n=83, 64) 61862.65  (21839.664) 62232.81  (25231.645)
Cycle 2 Day 1 (n=66, 48) 44987.88  (25631.702) 65843.75  (28889.260)
Cycle 3 Day 1 (n=49, 35) 30855.10  (12403.495) 63582.86  (22411.007)
Cycle 4 Day 1 (n=33, 27) 25887.88  (13895.183) 62885.19  (20790.173)
Cycle 5 Day 1 (n=28, 19) 21696.07  (12011.950) 54811.05  (14542.905)
Cycle 7 Day 1 (n=9, 8) 18166.67  (5406.246) 56237.50  (10577.056)
End Of Treatment (n=49, 11) 25004.08  (13431.632) 72854.55  (52888.909)
19.Secondary Outcome
Title Circulating Endothelial Cells (CEC)
Hide Description Blood samples were collected to enumerate the number of total CECs and sVEGFR1, sVEGFR2 and sVEGFR3 protein expression and/or cellular viability.
Time Frame Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. n = participants with available data at that time point.
Arm/Group Title Sunitinib Standard of Care
Hide Arm/Group Description:
SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
Overall Number of Participants Analyzed 42 48
Mean (Standard Deviation)
Unit of Measure: cells/mL
Cycle 1, Day 1 (n=42, 48) 944.67  (1784.549) 1176.92  (2704.135)
Cycle 1, Day 15 (n=28, 37) 630  (1210.431) 1199.32  (2334.643)
Cycle 2, Day 1 (n=33, 35) 512.39  (790.018) 1048.31  (2415.424)
Cycle 2, Day 15 (n=7, 5) 1310.86  (725.107) 852.96  (438.779)
Cycle 3, Day 1 (n=27, 25) 390.09  (490.173) 509.75  (665.236)
Cycle 3, Day 15 (n=4, 1) 923.85  (1274.882) 231.80  (0)
Cycle 4, Day 1 (n=3, 5) 169.24  (73.614) 976.79  (1185.180)
Cycle 5, Day 1 (n=2, 2) 145.68  (178.643) 2031.67  (105.932)
EOT (n=18, 18) 477.83  (780.161) 1087.94  (1713.581)
20.Secondary Outcome
Title Circulating Tumor Cells (CTC)
Hide Description Blood samples were collected to enumerate the number of total CTCs and insulin growth factor 1R positive (IGF-1R+) CTCs
Time Frame Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population. n = participants with available data at that time point.
Arm/Group Title Sunitinib Standard of Care
Hide Arm/Group Description:
SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
Overall Number of Participants Analyzed 20 17
Mean (Standard Deviation)
Unit of Measure: cells/7.5 mL
Cycle 1, Day 1 (n=33, 28) 119.76  (495.731) 17.71  (44.139)
Cycle 1, Day 15 (n=20, 16) 183.60  (672.994) 10.69  (24.811)
Cycle 2, Day 1 (n=19, 17) 189  (701.533) 3.18  (6.317)
Cycle 2, Day 15 (n=3, 7) 33.33  (50.143) 0.86  (1.215)
Cycle 3, Day 1 (n=8, 15) 36.50  (40.918) 10.60  (28.045)
Cycle 3, Day 15 (n=2, 4) 40.50  (28.991) 0  (0)
Cycle 4, Day 1 (n=2, 5) 61  (0) 0.60  (1.342)
Cycle 5, Day 1 (n=2, 3) 19.50  (23.335) 0.33  (0.577)
EOT (n=17,4) 55  (105.796) 3  (4)
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Sunitinib Standard of Care
Hide Arm/Group Description SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities. One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 milligrams per square meter (mg/m^2) twice daily (BID) Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid intravenous (IV) infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If Response Evaluation Criteria in Solid Tumors (RECIST) defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
All-Cause Mortality
Sunitinib Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sunitinib Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   40/110 (36.36%)   21/103 (20.39%) 
Blood and lymphatic system disorders     
Anaemia * 1  3/110 (2.73%)  0/103 (0.00%) 
Disseminated intravascular coagulation * 1  1/110 (0.91%)  0/103 (0.00%) 
Febrile neutropenia * 1  2/110 (1.82%)  2/103 (1.94%) 
Leukopenia * 1  0/110 (0.00%)  1/103 (0.97%) 
Pancytopenia * 1  1/110 (0.91%)  0/103 (0.00%) 
Thrombocytopenia * 1  2/110 (1.82%)  0/103 (0.00%) 
Cardiac disorders     
Atrial fibrillation * 1  1/110 (0.91%)  1/103 (0.97%) 
Cardiac arrest * 1  1/110 (0.91%)  0/103 (0.00%) 
Cardiac failure * 1  1/110 (0.91%)  0/103 (0.00%) 
Cardiopulmonary failure * 1  1/110 (0.91%)  0/103 (0.00%) 
Myocardial ischaemia * 1  1/110 (0.91%)  0/103 (0.00%) 
Supraventricular tachycardia * 1  0/110 (0.00%)  1/103 (0.97%) 
Gastrointestinal disorders     
Abdominal pain * 1  4/110 (3.64%)  1/103 (0.97%) 
Abdominal pain lower * 1  1/110 (0.91%)  0/103 (0.00%) 
Abdominal pain upper * 1  1/110 (0.91%)  0/103 (0.00%) 
Constipation * 1  1/110 (0.91%)  0/103 (0.00%) 
Faeces discoloured * 1  1/110 (0.91%)  0/103 (0.00%) 
Gastritis * 1  0/110 (0.00%)  1/103 (0.97%) 
Mouth ulceration * 1  1/110 (0.91%)  0/103 (0.00%) 
Nausea * 1  1/110 (0.91%)  2/103 (1.94%) 
Pancreatitis * 1  1/110 (0.91%)  0/103 (0.00%) 
Vomiting * 1  2/110 (1.82%)  3/103 (2.91%) 
Ascites * 1  1/110 (0.91%)  0/103 (0.00%) 
General disorders     
Asthenia * 1  4/110 (3.64%)  1/103 (0.97%) 
Axillary pain * 1  1/110 (0.91%)  0/103 (0.00%) 
Disease progression * 1  16/110 (14.55%)  3/103 (2.91%) 
Fatigue * 1  2/110 (1.82%)  0/103 (0.00%) 
Hyperthermia * 1  1/110 (0.91%)  0/103 (0.00%) 
Mucosal inflammation * 1  0/110 (0.00%)  1/103 (0.97%) 
Pyrexia * 1  0/110 (0.00%)  1/103 (0.97%) 
Hepatobiliary disorders     
Acute hepatic failure * 1  1/110 (0.91%)  0/103 (0.00%) 
Liver disorder * 1  0/110 (0.00%)  1/103 (0.97%) 
Infections and infestations     
Bronchopneumonia * 1  1/110 (0.91%)  0/103 (0.00%) 
Neutropenic sepsis * 1  0/110 (0.00%)  1/103 (0.97%) 
Pyelonephritis * 1  0/110 (0.00%)  1/103 (0.97%) 
Staphylococcal infection * 1  1/110 (0.91%)  0/103 (0.00%) 
Urinary tract infection * 1  0/110 (0.00%)  1/103 (0.97%) 
Urosepsis * 1  1/110 (0.91%)  1/103 (0.97%) 
Injury, poisoning and procedural complications     
Concussion * 1  1/110 (0.91%)  0/103 (0.00%) 
Femur fracture * 1  0/110 (0.00%)  1/103 (0.97%) 
Investigations     
Blood bilirubin increased * 1  1/110 (0.91%)  0/103 (0.00%) 
Blood creatinine increased * 1  1/110 (0.91%)  0/103 (0.00%) 
Lipase increased * 1  1/110 (0.91%)  0/103 (0.00%) 
Metabolism and nutrition disorders     
Failure to thrive * 1  1/110 (0.91%)  0/103 (0.00%) 
Hyperglycaemia * 1  0/110 (0.00%)  1/103 (0.97%) 
Musculoskeletal and connective tissue disorders     
Back pain * 1  0/110 (0.00%)  1/103 (0.97%) 
Bone pain * 1  1/110 (0.91%)  0/103 (0.00%) 
Neck pain * 1  1/110 (0.91%)  0/103 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lymphangiosis carcinomatosa * 1  1/110 (0.91%)  0/103 (0.00%) 
Malignant pleural effusion * 1  1/110 (0.91%)  0/103 (0.00%) 
Nervous system disorders     
Headache * 1  2/110 (1.82%)  0/103 (0.00%) 
Ischaemic stroke * 1  0/110 (0.00%)  1/103 (0.97%) 
Migraine * 1  1/110 (0.91%)  0/103 (0.00%) 
Presyncope * 1  0/110 (0.00%)  1/103 (0.97%) 
Transient ischaemic attack * 1  0/110 (0.00%)  1/103 (0.97%) 
Psychiatric disorders     
Agitation * 1  1/110 (0.91%)  0/103 (0.00%) 
Confusional state * 1  1/110 (0.91%)  0/103 (0.00%) 
Depression * 1  1/110 (0.91%)  0/103 (0.00%) 
Hallucination, visual * 1  1/110 (0.91%)  0/103 (0.00%) 
Suicide attempt * 1  0/110 (0.00%)  1/103 (0.97%) 
Renal and urinary disorders     
Hydronephrosis * 1  1/110 (0.91%)  0/103 (0.00%) 
Cystitis haemorrhagic * 1  0/110 (0.00%)  1/103 (0.97%) 
Reproductive system and breast disorders     
Breast pain * 1  1/110 (0.91%)  0/103 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  1/110 (0.91%)  0/103 (0.00%) 
Dyspnoea * 1  5/110 (4.55%)  1/103 (0.97%) 
Dyspnoea exertional * 1  1/110 (0.91%)  0/103 (0.00%) 
Haemoptysis * 1  0/110 (0.00%)  1/103 (0.97%) 
Hydrothorax * 1  0/110 (0.00%)  1/103 (0.97%) 
Hypoxia * 1  1/110 (0.91%)  1/103 (0.97%) 
Lung infiltration * 1  1/110 (0.91%)  0/103 (0.00%) 
Pleural effusion * 1  3/110 (2.73%)  3/103 (2.91%) 
Pleuritic pain * 1  1/110 (0.91%)  0/103 (0.00%) 
Pneumothorax * 1  3/110 (2.73%)  0/103 (0.00%) 
Pulmonary embolism * 1  3/110 (2.73%)  0/103 (0.00%) 
Surgical and medical procedures     
Ureteral stent insertion * 1  1/110 (0.91%)  0/103 (0.00%) 
Vascular disorders     
Deep vein thrombosis * 1  0/110 (0.00%)  1/103 (0.97%) 
Hypertension * 1  2/110 (1.82%)  0/103 (0.00%) 
Hypotension * 1  1/110 (0.91%)  1/103 (0.97%) 
Thrombosis * 1  1/110 (0.91%)  1/103 (0.97%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sunitinib Standard of Care
Affected / at Risk (%) Affected / at Risk (%)
Total   109/110 (99.09%)   98/103 (95.15%) 
Blood and lymphatic system disorders     
Anaemia * 1  15/110 (13.64%)  17/103 (16.50%) 
Leukopenia * 1  24/110 (21.82%)  8/103 (7.77%) 
Neutropenia * 1  34/110 (30.91%)  24/103 (23.30%) 
Thrombocytopenia * 1  27/110 (24.55%)  7/103 (6.80%) 
Hypercoagulation * 1  1/110 (0.91%)  0/103 (0.00%) 
Lymphadenopathy * 1  2/110 (1.82%)  0/103 (0.00%) 
Lymphopenia * 1  1/110 (0.91%)  1/103 (0.97%) 
Cardiac disorders     
Atrial fibrillation * 1  2/110 (1.82%)  0/103 (0.00%) 
Left ventricular dysfunction * 1  1/110 (0.91%)  0/103 (0.00%) 
Palpitations * 1  1/110 (0.91%)  2/103 (1.94%) 
Tachycardia * 1  2/110 (1.82%)  2/103 (1.94%) 
Ear and labyrinth disorders     
Deafness unilateral * 1  1/110 (0.91%)  0/103 (0.00%) 
Ear discomfort * 1  1/110 (0.91%)  0/103 (0.00%) 
Ear pain * 1  2/110 (1.82%)  1/103 (0.97%) 
Tinnitus * 1  0/110 (0.00%)  1/103 (0.97%) 
Vertigo * 1  3/110 (2.73%)  2/103 (1.94%) 
Endocrine disorders     
Hypothyroidism * 1  15/110 (13.64%)  3/103 (2.91%) 
Hyperthyroidism * 1  0/110 (0.00%)  1/103 (0.97%) 
Eye disorders     
Conjunctivitis * 1  6/110 (5.45%)  3/103 (2.91%) 
Eye oedema * 1  0/110 (0.00%)  1/103 (0.97%) 
Eye swelling * 1  1/110 (0.91%)  0/103 (0.00%) 
Eyelid oedema * 1  2/110 (1.82%)  0/103 (0.00%) 
Eyelid pain * 1  1/110 (0.91%)  0/103 (0.00%) 
Eyelid ptosis * 1  0/110 (0.00%)  1/103 (0.97%) 
Glare * 1  0/110 (0.00%)  1/103 (0.97%) 
Keratoconjunctivitis sicca * 1  1/110 (0.91%)  0/103 (0.00%) 
Lacrimation increased * 1  2/110 (1.82%)  3/103 (2.91%) 
Periorbital oedema * 1  6/110 (5.45%)  1/103 (0.97%) 
Photophobia * 1  1/110 (0.91%)  0/103 (0.00%) 
Vision blurred * 1  4/110 (3.64%)  0/103 (0.00%) 
Visual impairment * 1  1/110 (0.91%)  1/103 (0.97%) 
Gastrointestinal disorders     
Abdominal pain * 1  12/110 (10.91%)  8/103 (7.77%) 
Abdominal pain upper * 1  10/110 (9.09%)  5/103 (4.85%) 
Constipation * 1  13/110 (11.82%)  17/103 (16.50%) 
Diarrhoea * 1  50/110 (45.45%)  26/103 (25.24%) 
Dyspepsia * 1  19/110 (17.27%)  6/103 (5.83%) 
Nausea * 1  52/110 (47.27%)  36/103 (34.95%) 
Stomatitis * 1  15/110 (13.64%)  6/103 (5.83%) 
Vomiting * 1  26/110 (23.64%)  17/103 (16.50%) 
Abdominal discomfort * 1  0/110 (0.00%)  1/103 (0.97%) 
Abdominal distension * 1  2/110 (1.82%)  1/103 (0.97%) 
Abdominal pain lower * 1  1/110 (0.91%)  1/103 (0.97%) 
Aphthous stomatitis * 1  0/110 (0.00%)  1/103 (0.97%) 
Breath odour * 1  1/110 (0.91%)  0/103 (0.00%) 
Cheilitis * 1  2/110 (1.82%)  0/103 (0.00%) 
Dental caries * 1  0/110 (0.00%)  1/103 (0.97%) 
Dry mouth * 1  6/110 (5.45%)  3/103 (2.91%) 
Dysphagia * 1  1/110 (0.91%)  2/103 (1.94%) 
Enteritis * 1  1/110 (0.91%)  0/103 (0.00%) 
Flatulence * 1  3/110 (2.73%)  2/103 (1.94%) 
Gastritis * 1  2/110 (1.82%)  1/103 (0.97%) 
Gastrooesophageal reflux disease * 1  6/110 (5.45%)  1/103 (0.97%) 
Gingival bleeding * 1  5/110 (4.55%)  0/103 (0.00%) 
Gingival pain * 1  0/110 (0.00%)  1/103 (0.97%) 
Gingivitis * 1  1/110 (0.91%)  0/103 (0.00%) 
Glossodynia * 1  4/110 (3.64%)  0/103 (0.00%) 
Haemorrhoidal haemorrhage * 1  1/110 (0.91%)  0/103 (0.00%) 
Haemorrhoids * 1  1/110 (0.91%)  0/103 (0.00%) 
Intestinal obstruction * 1  1/110 (0.91%)  0/103 (0.00%) 
Mouth ulceration * 1  2/110 (1.82%)  0/103 (0.00%) 
Oral mucosal erythema * 1  1/110 (0.91%)  0/103 (0.00%) 
Oral pain * 1  7/110 (6.36%)  0/103 (0.00%) 
Painful defaecation * 1  1/110 (0.91%)  0/103 (0.00%) 
Rectal haemorrhage * 1  1/110 (0.91%)  0/103 (0.00%) 
Reflux oesophagitis * 1  2/110 (1.82%)  0/103 (0.00%) 
Tongue disorder * 1  2/110 (1.82%)  0/103 (0.00%) 
Tooth discolouration * 1  1/110 (0.91%)  0/103 (0.00%) 
Toothache * 1  1/110 (0.91%)  0/103 (0.00%) 
General disorders     
Asthenia * 1  32/110 (29.09%)  15/103 (14.56%) 
Chest pain * 1  9/110 (8.18%)  7/103 (6.80%) 
Fatigue * 1  41/110 (37.27%)  38/103 (36.89%) 
Mucosal inflammation * 1  30/110 (27.27%)  16/103 (15.53%) 
Oedema peripheral * 1  7/110 (6.36%)  7/103 (6.80%) 
Pyrexia * 1  9/110 (8.18%)  17/103 (16.50%) 
Axillary pain * 1  1/110 (0.91%)  0/103 (0.00%) 
Bloody discharge * 1  0/110 (0.00%)  1/103 (0.97%) 
Chills * 1  3/110 (2.73%)  0/103 (0.00%) 
Device occlusion * 1  1/110 (0.91%)  0/103 (0.00%) 
Face oedema * 1  2/110 (1.82%)  2/103 (1.94%) 
Generalised oedema * 1  1/110 (0.91%)  0/103 (0.00%) 
Influenza like illness * 1  2/110 (1.82%)  2/103 (1.94%) 
Localised oedema * 1  1/110 (0.91%)  0/103 (0.00%) 
Nodule * 1  1/110 (0.91%)  0/103 (0.00%) 
Non-cardiac chest pain * 1  1/110 (0.91%)  2/103 (1.94%) 
Oedema * 1  3/110 (2.73%)  2/103 (1.94%) 
Pain * 1  1/110 (0.91%)  5/103 (4.85%) 
Therapeutic response unexpected * 1  1/110 (0.91%)  0/103 (0.00%) 
Ulcer * 1  1/110 (0.91%)  0/103 (0.00%) 
Hepatobiliary disorders     
Caput medusae * 1  1/110 (0.91%)  0/103 (0.00%) 
Cholestasis * 1  1/110 (0.91%)  0/103 (0.00%) 
Hepatic failure * 1  0/110 (0.00%)  1/103 (0.97%) 
Hepatic pain * 1  0/110 (0.00%)  1/103 (0.97%) 
Hepatitis * 1  1/110 (0.91%)  0/103 (0.00%) 
Hyperbilirubinaemia * 1  1/110 (0.91%)  0/103 (0.00%) 
Jaundice * 1  1/110 (0.91%)  0/103 (0.00%) 
Immune system disorders     
Contrast media allergy * 1  2/110 (1.82%)  0/103 (0.00%) 
Hypersensitivity * 1  1/110 (0.91%)  0/103 (0.00%) 
Infections and infestations     
Bacteriuria * 1  1/110 (0.91%)  0/103 (0.00%) 
Breast infection * 1  1/110 (0.91%)  2/103 (1.94%) 
Bronchitis * 1  0/110 (0.00%)  1/103 (0.97%) 
Candidiasis * 1  1/110 (0.91%)  0/103 (0.00%) 
Cellulitis * 1  0/110 (0.00%)  1/103 (0.97%) 
Chest wall abscess * 1  1/110 (0.91%)  0/103 (0.00%) 
Cystitis * 1  4/110 (3.64%)  0/103 (0.00%) 
Device related infection * 1  1/110 (0.91%)  0/103 (0.00%) 
Ear infection * 1  0/110 (0.00%)  1/103 (0.97%) 
Erysipelas * 1  0/110 (0.00%)  2/103 (1.94%) 
Eye infection * 1  0/110 (0.00%)  1/103 (0.97%) 
Fungal infection * 1  1/110 (0.91%)  1/103 (0.97%) 
Fungal skin infection * 1  1/110 (0.91%)  0/103 (0.00%) 
Gastroenteritis * 1  1/110 (0.91%)  0/103 (0.00%) 
Gastroenteritis viral * 1  0/110 (0.00%)  1/103 (0.97%) 
Herpes simplex * 1  2/110 (1.82%)  0/103 (0.00%) 
Herpes virus infection * 1  1/110 (0.91%)  0/103 (0.00%) 
Herpes zoster * 1  1/110 (0.91%)  0/103 (0.00%) 
Infection * 1  2/110 (1.82%)  1/103 (0.97%) 
Influenza * 1  1/110 (0.91%)  5/103 (4.85%) 
Localised infection * 1  1/110 (0.91%)  1/103 (0.97%) 
Lymph gland infection * 1  1/110 (0.91%)  0/103 (0.00%) 
Nasopharyngitis * 1  2/110 (1.82%)  4/103 (3.88%) 
Oral candidiasis * 1  2/110 (1.82%)  1/103 (0.97%) 
Oral herpes * 1  2/110 (1.82%)  2/103 (1.94%) 
Paronychia * 1  0/110 (0.00%)  2/103 (1.94%) 
Pharyngitis * 1  1/110 (0.91%)  0/103 (0.00%) 
Pneumonia * 1  1/110 (0.91%)  0/103 (0.00%) 
Post procedural infection * 1  0/110 (0.00%)  1/103 (0.97%) 
Respiratory tract infection * 1  0/110 (0.00%)  1/103 (0.97%) 
Rhinitis * 1  1/110 (0.91%)  2/103 (1.94%) 
Sinusitis * 1  1/110 (0.91%)  4/103 (3.88%) 
Skin candida * 1  0/110 (0.00%)  1/103 (0.97%) 
Skin infection * 1  3/110 (2.73%)  1/103 (0.97%) 
Subcutaneous abscess * 1  1/110 (0.91%)  0/103 (0.00%) 
Tinea pedis * 1  1/110 (0.91%)  0/103 (0.00%) 
Tooth abscess * 1  1/110 (0.91%)  1/103 (0.97%) 
Tooth infection * 1  1/110 (0.91%)  0/103 (0.00%) 
Upper respiratory tract infection * 1  2/110 (1.82%)  4/103 (3.88%) 
Urinary tract infection * 1  2/110 (1.82%)  5/103 (4.85%) 
Vaginal infection * 1  1/110 (0.91%)  0/103 (0.00%) 
Vulvovaginal candidiasis * 1  1/110 (0.91%)  1/103 (0.97%) 
Wound infection * 1  1/110 (0.91%)  0/103 (0.00%) 
Injury, poisoning and procedural complications     
Contusion * 1  5/110 (4.55%)  2/103 (1.94%) 
Joint injury * 1  0/110 (0.00%)  1/103 (0.97%) 
Open wound * 1  0/110 (0.00%)  1/103 (0.97%) 
Post procedural haemorrhage * 1  1/110 (0.91%)  0/103 (0.00%) 
Radiation skin injury * 1  0/110 (0.00%)  1/103 (0.97%) 
Thermal burn * 1  2/110 (1.82%)  0/103 (0.00%) 
Wound dehiscence * 1  1/110 (0.91%)  0/103 (0.00%) 
Investigations     
Alanine aminotransferase increased * 1  6/110 (5.45%)  5/103 (4.85%) 
Aspartate aminotransferase increased * 1  8/110 (7.27%)  5/103 (4.85%) 
Platelet count decreased * 1  14/110 (12.73%)  1/103 (0.97%) 
Weight decreased * 1  12/110 (10.91%)  3/103 (2.91%) 
Activated partial thromboplastin time prolonged * 1  1/110 (0.91%)  0/103 (0.00%) 
Blood alkaline phosphatase increased * 1  6/110 (5.45%)  0/103 (0.00%) 
Blood bilirubin increased * 1  2/110 (1.82%)  0/103 (0.00%) 
Blood lactate dehydrogenase increased * 1  2/110 (1.82%)  0/103 (0.00%) 
Blood magnesium decreased * 1  2/110 (1.82%)  0/103 (0.00%) 
Blood thyroid stimulating hormone increased * 1  1/110 (0.91%)  0/103 (0.00%) 
Ejection fraction decreased * 1  0/110 (0.00%)  1/103 (0.97%) 
Electrocardiogram ST segment elevation * 1  0/110 (0.00%)  1/103 (0.97%) 
Gamma-glutamyltransferase increased * 1  1/110 (0.91%)  1/103 (0.97%) 
Haemoglobin decreased * 1  3/110 (2.73%)  1/103 (0.97%) 
Hypophonesis * 1  1/110 (0.91%)  1/103 (0.97%) 
Neutrophil count decreased * 1  5/110 (4.55%)  4/103 (3.88%) 
Renal function test abnormal * 1  1/110 (0.91%)  0/103 (0.00%) 
Urine output decreased * 1  1/110 (0.91%)  0/103 (0.00%) 
Weight increased * 1  1/110 (0.91%)  1/103 (0.97%) 
White blood cell count decreased * 1  6/110 (5.45%)  3/103 (2.91%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  29/110 (26.36%)  12/103 (11.65%) 
Hypokalaemia * 1  5/110 (4.55%)  6/103 (5.83%) 
Dehydration * 1  5/110 (4.55%)  1/103 (0.97%) 
Fluid retention * 1  1/110 (0.91%)  1/103 (0.97%) 
Hypercalcaemia * 1  0/110 (0.00%)  1/103 (0.97%) 
Hyperglycaemia * 1  2/110 (1.82%)  2/103 (1.94%) 
Hypertriglyceridaemia * 1  0/110 (0.00%)  1/103 (0.97%) 
Hyperuricaemia * 1  1/110 (0.91%)  0/103 (0.00%) 
Hypoalbuminaemia * 1  4/110 (3.64%)  0/103 (0.00%) 
Hypocalcaemia * 1  4/110 (3.64%)  2/103 (1.94%) 
Hypoglycaemia * 1  1/110 (0.91%)  0/103 (0.00%) 
Hypomagnesaemia * 1  3/110 (2.73%)  3/103 (2.91%) 
Hyponatraemia * 1  2/110 (1.82%)  0/103 (0.00%) 
Hypophosphataemia * 1  1/110 (0.91%)  1/103 (0.97%) 
Hyposideraemia * 1  0/110 (0.00%)  1/103 (0.97%) 
Hypovolaemia * 1  0/110 (0.00%)  1/103 (0.97%) 
Tetany * 1  0/110 (0.00%)  1/103 (0.97%) 
Vitamin A deficiency * 1  0/110 (0.00%)  1/103 (0.97%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  9/110 (8.18%)  2/103 (1.94%) 
Back pain * 1  12/110 (10.91%)  9/103 (8.74%) 
Musculoskeletal chest pain * 1  12/110 (10.91%)  6/103 (5.83%) 
Musculoskeletal pain * 1  7/110 (6.36%)  9/103 (8.74%) 
Neck pain * 1  8/110 (7.27%)  4/103 (3.88%) 
Pain in extremity * 1  19/110 (17.27%)  9/103 (8.74%) 
Arthritis * 1  0/110 (0.00%)  1/103 (0.97%) 
Bone pain * 1  4/110 (3.64%)  5/103 (4.85%) 
Groin pain * 1  1/110 (0.91%)  0/103 (0.00%) 
Joint stiffness * 1  1/110 (0.91%)  0/103 (0.00%) 
Joint swelling * 1  1/110 (0.91%)  0/103 (0.00%) 
Muscle spasms * 1  5/110 (4.55%)  5/103 (4.85%) 
Muscular weakness * 1  1/110 (0.91%)  1/103 (0.97%) 
Myalgia * 1  4/110 (3.64%)  4/103 (3.88%) 
Nuchal rigidity * 1  1/110 (0.91%)  0/103 (0.00%) 
Osteoporosis * 1  0/110 (0.00%)  1/103 (0.97%) 
Pain in jaw * 1  2/110 (1.82%)  1/103 (0.97%) 
Periarthritis * 1  1/110 (0.91%)  0/103 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Infected neoplasm * 1  0/110 (0.00%)  1/103 (0.97%) 
Lymphangiosis carcinomatosa * 1  1/110 (0.91%)  0/103 (0.00%) 
Malignant pleural effusion * 1  0/110 (0.00%)  1/103 (0.97%) 
Neoplasm * 1  1/110 (0.91%)  0/103 (0.00%) 
Tumour pain * 1  1/110 (0.91%)  1/103 (0.97%) 
Nervous system disorders     
Dizziness * 1  6/110 (5.45%)  6/103 (5.83%) 
Dysgeusia * 1  23/110 (20.91%)  5/103 (4.85%) 
Headache * 1  19/110 (17.27%)  13/103 (12.62%) 
Ageusia * 1  2/110 (1.82%)  0/103 (0.00%) 
Amnesia * 1  2/110 (1.82%)  0/103 (0.00%) 
Aphasia * 1  0/110 (0.00%)  1/103 (0.97%) 
Ataxia * 1  2/110 (1.82%)  0/103 (0.00%) 
Burning sensation * 1  1/110 (0.91%)  0/103 (0.00%) 
Cognitive disorder * 1  1/110 (0.91%)  0/103 (0.00%) 
Depressed level of consciousness * 1  1/110 (0.91%)  0/103 (0.00%) 
Dysarthria * 1  1/110 (0.91%)  1/103 (0.97%) 
Epilepsy * 1  0/110 (0.00%)  1/103 (0.97%) 
Hemiplegia * 1  1/110 (0.91%)  0/103 (0.00%) 
Hyperaesthesia * 1  1/110 (0.91%)  0/103 (0.00%) 
Hypoaesthesia * 1  1/110 (0.91%)  2/103 (1.94%) 
IIIrd nerve paralysis * 1  1/110 (0.91%)  0/103 (0.00%) 
Lethargy * 1  1/110 (0.91%)  0/103 (0.00%) 
Memory impairment * 1  0/110 (0.00%)  1/103 (0.97%) 
Migraine * 1  0/110 (0.00%)  2/103 (1.94%) 
Neuralgia * 1  3/110 (2.73%)  1/103 (0.97%) 
Neuropathy peripheral * 1  4/110 (3.64%)  4/103 (3.88%) 
Neurotoxicity * 1  0/110 (0.00%)  1/103 (0.97%) 
Paraesthesia * 1  3/110 (2.73%)  5/103 (4.85%) 
Parosmia * 1  1/110 (0.91%)  1/103 (0.97%) 
Peripheral sensory neuropathy * 1  1/110 (0.91%)  4/103 (3.88%) 
Presyncope * 1  0/110 (0.00%)  1/103 (0.97%) 
Sensory disturbance * 1  0/110 (0.00%)  1/103 (0.97%) 
Sinus headache * 1  0/110 (0.00%)  1/103 (0.97%) 
Somnolence * 1  2/110 (1.82%)  0/103 (0.00%) 
Spinal cord compression * 1  0/110 (0.00%)  1/103 (0.97%) 
Syncope * 1  1/110 (0.91%)  1/103 (0.97%) 
Tongue paralysis * 1  0/110 (0.00%)  1/103 (0.97%) 
Psychiatric disorders     
Anxiety * 1  9/110 (8.18%)  4/103 (3.88%) 
Insomnia * 1  7/110 (6.36%)  10/103 (9.71%) 
Agitation * 1  0/110 (0.00%)  1/103 (0.97%) 
Confusional state * 1  1/110 (0.91%)  1/103 (0.97%) 
Depressed mood * 1  0/110 (0.00%)  1/103 (0.97%) 
Depression * 1  3/110 (2.73%)  4/103 (3.88%) 
Mental status changes * 1  1/110 (0.91%)  0/103 (0.00%) 
Renal and urinary disorders     
Calculus ureteric * 1  1/110 (0.91%)  0/103 (0.00%) 
Chromaturia * 1  1/110 (0.91%)  0/103 (0.00%) 
Dysuria * 1  2/110 (1.82%)  2/103 (1.94%) 
Haematuria * 1  1/110 (0.91%)  0/103 (0.00%) 
Haemorrhage urinary tract * 1  1/110 (0.91%)  0/103 (0.00%) 
Micturition urgency * 1  1/110 (0.91%)  0/103 (0.00%) 
Pollakiuria * 1  2/110 (1.82%)  0/103 (0.00%) 
Polyuria * 1  1/110 (0.91%)  0/103 (0.00%) 
Proteinuria * 1  3/110 (2.73%)  0/103 (0.00%) 
Renal pain * 1  1/110 (0.91%)  0/103 (0.00%) 
Urinary incontinence * 1  1/110 (0.91%)  0/103 (0.00%) 
Reproductive system and breast disorders     
Breast pain * 1  7/110 (6.36%)  5/103 (4.85%) 
Breast discolouration * 1  1/110 (0.91%)  0/103 (0.00%) 
Breast disorder * 1  1/110 (0.91%)  0/103 (0.00%) 
Breast haemorrhage * 1  1/110 (0.91%)  0/103 (0.00%) 
Genital haemorrhage * 1  1/110 (0.91%)  0/103 (0.00%) 
Menstruation irregular * 1  1/110 (0.91%)  0/103 (0.00%) 
Pelvic pain * 1  2/110 (1.82%)  0/103 (0.00%) 
Perineal pain * 1  1/110 (0.91%)  0/103 (0.00%) 
Vaginal haemorrhage * 1  2/110 (1.82%)  0/103 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  19/110 (17.27%)  13/103 (12.62%) 
Dyspnoea * 1  25/110 (22.73%)  13/103 (12.62%) 
Epistaxis * 1  11/110 (10.00%)  4/103 (3.88%) 
Pleural effusion * 1  6/110 (5.45%)  5/103 (4.85%) 
Dysphonia * 1  0/110 (0.00%)  2/103 (1.94%) 
Dyspnoea exertional * 1  1/110 (0.91%)  2/103 (1.94%) 
Haemoptysis * 1  1/110 (0.91%)  0/103 (0.00%) 
Hiccups * 1  2/110 (1.82%)  0/103 (0.00%) 
Hydrothorax * 1  1/110 (0.91%)  1/103 (0.97%) 
Hypoxia * 1  2/110 (1.82%)  1/103 (0.97%) 
Laryngeal oedema * 1  1/110 (0.91%)  0/103 (0.00%) 
Lung disorder * 1  1/110 (0.91%)  0/103 (0.00%) 
Lung infiltration * 1  1/110 (0.91%)  0/103 (0.00%) 
Nasal dryness * 1  1/110 (0.91%)  0/103 (0.00%) 
Oropharyngeal pain * 1  2/110 (1.82%)  4/103 (3.88%) 
Paranasal sinus hypersecretion * 1  0/110 (0.00%)  2/103 (1.94%) 
Pleuritic pain * 1  1/110 (0.91%)  0/103 (0.00%) 
Pneumothorax * 1  1/110 (0.91%)  0/103 (0.00%) 
Rales * 1  0/110 (0.00%)  1/103 (0.97%) 
Respiratory distress * 1  1/110 (0.91%)  0/103 (0.00%) 
Respiratory tract congestion * 1  1/110 (0.91%)  0/103 (0.00%) 
Rhinorrhoea * 1  0/110 (0.00%)  2/103 (1.94%) 
Sinus congestion * 1  1/110 (0.91%)  0/103 (0.00%) 
Tachypnoea * 1  0/110 (0.00%)  1/103 (0.97%) 
Skin and subcutaneous tissue disorders     
Erythema * 1  11/110 (10.00%)  3/103 (2.91%) 
Palmar—plantar erythrodysaesthesia syndrome * 1  27/110 (24.55%)  27/103 (26.21%) 
Rash * 1  10/110 (9.09%)  1/103 (0.97%) 
Skin discolouration * 1  18/110 (16.36%)  0/103 (0.00%) 
Acne * 1  1/110 (0.91%)  0/103 (0.00%) 
Alopecia * 1  4/110 (3.64%)  6/103 (5.83%) 
Angioedema * 1  1/110 (0.91%)  0/103 (0.00%) 
Blister * 1  3/110 (2.73%)  1/103 (0.97%) 
Dermatitis * 1  1/110 (0.91%)  0/103 (0.00%) 
Dermatitis acneiform * 1  2/110 (1.82%)  0/103 (0.00%) 
Dermatitis allergic * 1  1/110 (0.91%)  1/103 (0.97%) 
Dermatitis exfoliative * 1  1/110 (0.91%)  0/103 (0.00%) 
Dry skin * 1  7/110 (6.36%)  1/103 (0.97%) 
Ecchymosis * 1  2/110 (1.82%)  0/103 (0.00%) 
Eczema * 1  1/110 (0.91%)  0/103 (0.00%) 
Hair colour changes * 1  4/110 (3.64%)  0/103 (0.00%) 
Hyperkeratosis * 1  3/110 (2.73%)  0/103 (0.00%) 
Increased tendency to bruise * 1  0/110 (0.00%)  1/103 (0.97%) 
Madarosis * 1  1/110 (0.91%)  0/103 (0.00%) 
Nail disorder * 1  3/110 (2.73%)  4/103 (3.88%) 
Nail toxicity * 1  0/110 (0.00%)  2/103 (1.94%) 
Onycholysis * 1  1/110 (0.91%)  1/103 (0.97%) 
Palmar erythema * 1  1/110 (0.91%)  0/103 (0.00%) 
Petechiae * 1  1/110 (0.91%)  1/103 (0.97%) 
Plantar erythema * 1  1/110 (0.91%)  0/103 (0.00%) 
Pruritus * 1  7/110 (6.36%)  2/103 (1.94%) 
Purpura * 1  0/110 (0.00%)  1/103 (0.97%) 
Rash erythematous * 1  0/110 (0.00%)  1/103 (0.97%) 
Rash macular * 1  0/110 (0.00%)  1/103 (0.97%) 
Rash pruritic * 1  0/110 (0.00%)  1/103 (0.97%) 
Scar * 1  1/110 (0.91%)  0/103 (0.00%) 
Skin hyperpigmentation * 1  4/110 (3.64%)  2/103 (1.94%) 
Skin hypopigmentation * 1  1/110 (0.91%)  0/103 (0.00%) 
Skin irritation * 1  1/110 (0.91%)  0/103 (0.00%) 
Skin lesion * 1  4/110 (3.64%)  0/103 (0.00%) 
Skin odour abnormal * 1  1/110 (0.91%)  0/103 (0.00%) 
Skin toxicity * 1  1/110 (0.91%)  1/103 (0.97%) 
Skin ulcer * 1  1/110 (0.91%)  0/103 (0.00%) 
Telangiectasia * 1  1/110 (0.91%)  0/103 (0.00%) 
Yellow skin * 1  4/110 (3.64%)  0/103 (0.00%) 
Surgical and medical procedures     
Astringent therapy * 1  1/110 (0.91%)  0/103 (0.00%) 
Vascular disorders     
Hypertension * 1  26/110 (23.64%)  4/103 (3.88%) 
Lymphoedema * 1  4/110 (3.64%)  7/103 (6.80%) 
Accelerated hypertension * 1  1/110 (0.91%)  0/103 (0.00%) 
Axillary vein thrombosis * 1  0/110 (0.00%)  1/103 (0.97%) 
Deep vein thrombosis * 1  0/110 (0.00%)  2/103 (1.94%) 
Haematoma * 1  1/110 (0.91%)  0/103 (0.00%) 
Haemorrhage * 1  1/110 (0.91%)  0/103 (0.00%) 
Hot flush * 1  5/110 (4.55%)  3/103 (2.91%) 
Hypotension * 1  3/110 (2.73%)  2/103 (1.94%) 
Orthostatic hypotension * 1  0/110 (0.00%)  1/103 (0.97%) 
Pelvic venous thrombosis * 1  1/110 (0.91%)  0/103 (0.00%) 
Phlebitis superficial * 1  0/110 (0.00%)  1/103 (0.97%) 
Raynaud’s phenomenon * 1  1/110 (0.91%)  0/103 (0.00%) 
Subclavian vein thrombosis * 1  0/110 (0.00%)  1/103 (0.97%) 
Systolic hypertension * 1  1/110 (0.91%)  0/103 (0.00%) 
Thrombophlebitis * 1  0/110 (0.00%)  1/103 (0.97%) 
Thrombosis * 1  1/110 (0.91%)  1/103 (0.97%) 
Vena cava thrombosis * 1  0/110 (0.00%)  1/103 (0.97%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00246571     History of Changes
Other Study ID Numbers: A6181077
First Submitted: October 27, 2005
First Posted: October 31, 2005
Results First Submitted: May 31, 2011
Results First Posted: June 27, 2011
Last Update Posted: July 12, 2012