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Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00246571
Collaborator
(none)
217
Enrollment
113
Locations
2
Arms
65
Duration (Months)
1.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare progression free survival for SU011248 [sutent (sunitinib malate)] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
217 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Phase 2 Study Of SU011248 Versus Standard-Of-Care For Patients With Previously Treated, Advanced, Triple Receptor Negative (ER, PR, HER2) Breast Cancer
Study Start Date :
Jan 1, 2006
Actual Primary Completion Date :
May 1, 2010
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Drug: SU011248
SU011248 capsules administered orally, daily in a continuous regimen, 3-week cycles, starting dose of 37.5 mg daily. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity. Dose escalate SU011248 to 50-mg daily if minimal toxicities . Study will continue until disease progression. Patients randomized to or crossed over to SU011248 may continue beyond the time of Response Evaluation Criterion in Solid Tumors (RECIST) -defined progression at the discretion of the investigator in the case of clinical benefit.
Other Names:
  • Sutent, sunitinib malate

    		•
    Active Comparator: B

    Drug: Chemotherapy
    The choice of chemotherapy will be at the discretion of the investigator within the limits outlined below. Capecitabine - 1000-1250 mg/m2 twice daily days 1-14 every 3 weeks Vinorelbine - 25-30 mg/m2 rapid intravenous infusion or 60-80 mg/m2 oral weekly, expressed in 3-week cycles Docetaxel - 75-100 mg/m2 every 3 weeks Paclitaxel - 175-200 mg/m2 every 3 weeks Paclitaxel - 80-90 mg/m2 weekly, in a continuous regimen expressed in 3-week cycles or administration of 3 weeks of treatment followed by 1 week of rest. Use of the 3/1 regimen will require extra care in scheduling disease assessments. Gemcitabine - 800-1250 mg/m2 Days 1 and 8 every 3 weeks Study will continue until disease progression or it is in the best interest of the patient to discontinue based on achievement of maximum benefit or tolerability issues. At the time of progression patients randomized to chemotherapy will be offered crossover to single agent SU011248.

    Outcome Measures

    Primary Outcome Measures

    1. Progression-Free Survival (PFS) [Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)]

      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").

    Secondary Outcome Measures

    1. Proportion of Participants With Objective Response [Baseline until response or disease progression (up to 3 years from first dose)]

      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.

    2. Duration of Response (DR) [Time from first response to disease progression up to 3 years from first dose]

      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.

    3. Survival Probability at 1 Year [Baseline until death (up to 3 years after first dose of study medication)]

      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.

    4. Overall Survival (OS) [Baseline until death (up to 3 years after first dose of study medication)]

      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).

    5. 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) [Day 1, Cycle 1; Day 1, odd number cycles; and end of treatment (EOT)/withdrawal]

      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.

    6. HRQoL and Disease Related Symptoms as Measured by EORTC-QLQ-C30 Breast Cancer Module (BR23) Score [Day 1, Cycle 1; Day 1, odd number cycles; and EOT/withdrawal]

      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.

    7. Observed Plasma Trough Concentrations (Ctrough) of Sunitinib [Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3]

    8. Ctrough of SU012662 (Metabolite of Sunitinib) [Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3]

    9. Ctrough of Total Drug (Sunitinib + SU012662) [Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3]

    10. Dose-corrected Ctrough of Sunitinib [Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3]

      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.

    11. Dose-corrected Ctrough of SU012662 (Metabolite of Sunitinib) [Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3]

      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.

    12. Dose-corrected Ctrough of Total Drug (Sunitinib + SU012662) [Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3]

      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.

    13. Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2) [Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal]

      Plasma concentrations of sVEGFR2 were examined as a potential pharmacodynamic marker

    14. Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (sVEGFR3) [Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal]

      Plasma concentrations of sVEGFR3 were examined as a potential pharmacodynamic marker

    15. Plasma Concentration of Soluble Vascular Endothelial Growth Factor A (sVEGF-A) [Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal]

      Plasma concentrations of sVEGF-A were examined as a potential pharmacodynamic marker

    16. Plasma Concentration of Soluble Placental Growth Factor (sPlGF) [Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal]

      Plasma concentrations of sPlGF were examined as a potential pharmacodynamic marker

    17. Plasma Concentration of Soluble Kinase Insert Domain for Tyrosine (sKIT), a Stem Cell Factor Receptor [Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal]

      Plasma concentrations of sKIT were examined as a potential pharmacodynamic marker

    18. Circulating Endothelial Cells (CEC) [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]

      Blood samples were collected to enumerate the number of total CECs and sVEGFR1, sVEGFR2 and sVEGFR3 protein expression and/or cellular viability.

    19. Circulating Tumor Cells (CTC) [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]

      Blood samples were collected to enumerate the number of total CTCs and insulin growth factor 1R positive (IGF-1R+) CTCs

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Recurrent or metastatic breast cancer

    • Estrogen receptor (ER), progestin receptor (PR) and HER2/neu receptor (HER2) negative status

    • Prior treatment with an anthracycline and a taxane in the adjuvant or advanced disease setting

    • Relapse following adjuvant chemotherapy within 6 months of last treatment and/or received one or two chemotherapy regimens for advanced disease

    Exclusion Criteria:

    • More than two chemotherapy regimens for advanced disease

    • Uncontrolled/symptomatic spread of cancer to the brain

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Corona California United States 92879
    2 Pfizer Investigational Site Fullerton California United States 92835
    3 Pfizer Investigational Site Glendora California United States 91741
    4 Pfizer Investigational Site Los Angeles California United States 90095-1772
    5 Pfizer Investigational Site Los Angeles California United States 90095-7423
    6 Pfizer Investigational Site Los Angeles California United States 90095
    7 Pfizer Investigational Site Mission Hills California United States 91345
    8 Pfizer Investigational Site Northridge California United States 91325
    9 Pfizer Investigational Site Palm Springs California United States 92262-4885
    10 Pfizer Investigational Site Pasadena California United States 91105
    11 Pfizer Investigational Site Pomona California United States 91767
    12 Pfizer Investigational Site Rancho Cucamonga California United States 91730
    13 Pfizer Investigational Site Santa Monica California United States 90404
    14 Pfizer Investigational Site Valencia California United States 91355
    15 Pfizer Investigational Site West Covina California United States 91790
    16 Pfizer Investigational Site Aurora Colorado United States 80010
    17 Pfizer Investigational Site Washington District of Columbia United States 20010
    18 Pfizer Investigational Site Boca Raton Florida United States 33428
    19 Pfizer Investigational Site Gainesville Florida United States 32605-4391
    20 Pfizer Investigational Site Atlanta Georgia United States 30341
    21 Pfizer Investigational Site Atlanta Georgia United States 30342
    22 Pfizer Investigational Site Decatur Georgia United States 30033
    23 Pfizer Investigational Site Macon Georgia United States 31217
    24 Pfizer Investigational Site Marietta Georgia United States 30060
    25 Pfizer Investigational Site Tucker Georgia United States 30084
    26 Pfizer Investigational Site Zion Illinois United States 60099
    27 Pfizer Investigational Site Indianapolis Indiana United States 46202
    28 Pfizer Investigational Site Bloomfield Hills Michigan United States 48302
    29 Pfizer Investigational Site Brownstown Michigan United States 48183
    30 Pfizer Investigational Site Dearborn Michigan United States 48126
    31 Pfizer Investigational Site Detroit Michigan United States 48202
    32 Pfizer Investigational Site West Bloomfield Michigan United States 48322
    33 Pfizer Investigational Site Biloxi Mississippi United States 39532
    34 Pfizer Investigational Site Clarkson Valley Missouri United States 63011
    35 Pfizer Investigational Site St. Louis Missouri United States 63109
    36 Pfizer Investigational Site St. Louis Missouri United States 63141
    37 Pfizer Investigational Site Midland Park New Jersey United States 07432
    38 Pfizer Investigational Site Morristown New Jersey United States 07962
    39 Pfizer Investigational Site Paramus New Jersey United States 07652
    40 Pfizer Investigational Site Pompton Plains New Jersey United States 07444
    41 Pfizer Investigational Site Ridgewood New Jersey United States 07450
    42 Pfizer Investigational Site Summit New Jersey United States 07902
    43 Pfizer Investigational Site Westwood New Jersey United States 07675
    44 Pfizer Investigational Site Bronx New York United States 10451
    45 Pfizer Investigational Site Bronx New York United States 10461
    46 Pfizer Investigational Site Clinton North Carolina United States 28388
    47 Pfizer Investigational Site Goldsboro North Carolina United States 27534
    48 Pfizer Investigational Site Wilson North Carolina United States 27893
    49 Pfizer Investigational Site Del City Oklahoma United States 73115
    50 Pfizer Investigational Site Greensburg Pennsylvania United States 15601
    51 Pfizer Investigational Site Hershey Pennsylvania United States 17033-0850
    52 Pfizer Investigational Site Pittsburgh Pennsylvania United States 15213
    53 Pfizer Investigational Site Pittsburgh Pennsylvania United States 15232-1305
    54 Pfizer Investigational Site Wexford Pennsylvania United States 15090
    55 Pfizer Investigational Site Memphis Tennessee United States 38104
    56 Pfizer Investigational Site Memphis Tennessee United States 38120
    57 Pfizer Investigational Site Memphis Tennessee United States 38133
    58 Pfizer Investigational Site Dallas Texas United States 75230-2510
    59 Pfizer Investigational Site Dallas Texas United States 75230
    60 Pfizer Investigational Site Fort Worth Texas United States 76177
    61 Pfizer Investigational Site Houston Texas United States 77024
    62 Pfizer Investigational Site Houston Texas United States 77055
    63 Pfizer Investigational Site Plano Texas United States 75075
    64 Pfizer Investigational Site Plano Texas United States 75093
    65 Pfizer Investigational Site Richardson Texas United States 75080
    66 Pfizer Investigational Site San Antonio Texas United States 78207
    67 Pfizer Investigational Site San Antonio Texas United States 78217
    68 Pfizer Investigational Site San Antonio Texas United States 78229
    69 Pfizer Investigational Site San Antonio Texas United States 78258
    70 Pfizer Investigational Site San Atonio Texas United States 78229
    71 Pfizer Investigational Site Tyler Texas United States 75702
    72 Pfizer Investigational Site Federal Way Washington United States 98003
    73 Pfizer Investigational Site Lakewood Washington United States 98499
    74 Pfizer Investigational Site Puyallup Washington United States 98372
    75 Pfizer Investigational Site Seattle Washington United States 98104
    76 Pfizer Investigational Site Seattle Washington United States 98122
    77 Pfizer Investigational Site Tacoma Washington United States 98405
    78 Pfizer Investigational Site Sofia Bulgaria 1233
    79 Pfizer Investigational Site Sofia Bulgaria 1527
    80 Pfizer Investigational Site Sofia Bulgaria 1756
    81 Pfizer Investigational Site Stara Zagora Bulgaria 6000
    82 Pfizer Investigational Site Varna Bulgaria 9000
    83 Pfizer Investigational Site Edmonton Alberta Canada T6G 1Z2
    84 Pfizer Investigational Site Toronto Ontario Canada M4N 3M5
    85 Pfizer Investigational Site Brno Ceska Republika Czech Republic 656 91
    86 Pfizer Investigational Site Praha 8 Ceska Republika Czech Republic 180 81
    87 Pfizer Investigational Site Brno Czech Republic 656 91
    88 Pfizer Investigational Site Praha 8 Czech Republic 180 00
    89 Pfizer Investigational Site BESANCON Cedex 5 France 25052
    90 Pfizer Investigational Site BESANCON cedex France 25030
    91 Pfizer Investigational Site NANTES cedex France 44805
    92 Pfizer Investigational Site Paris Cedex 20 France 75970
    93 Pfizer Investigational Site Berlin Germany 10177
    94 Pfizer Investigational Site Budapest Hungary 1082
    95 Pfizer Investigational Site Budapest Hungary 1122
    96 Pfizer Investigational Site Aviano (PN) Italy 33081
    97 Pfizer Investigational Site Milano Italy 20100
    98 Pfizer Investigational Site Prato, FI Italy 59100
    99 Pfizer Investigational Site Barcelona Spain 08035
    100 Pfizer Investigational Site Gerona Spain 17007
    101 Pfizer Investigational Site Lleida Spain 25198
    102 Pfizer Investigational Site Malaga Spain 29010
    103 Pfizer Investigational Site Sevilla Spain 41013
    104 Pfizer Investigational Site Adana Balcali Turkey 01330
    105 Pfizer Investigational Site Ankara Besevler Turkey 06510
    106 Pfizer Investigational Site Istanbul Pendik Turkey 34890
    107 Pfizer Investigational Site Ankara Sihhiye Turkey 06100
    108 Pfizer Investigational Site Dnipropetrovsk Ukraine 49102
    109 Pfizer Investigational Site Kyiv Ukraine 03115
    110 Pfizer Investigational Site Odessa Ukraine 65055
    111 Pfizer Investigational Site Edinburgh United Kingdom EH4 2XU
    112 Pfizer Investigational Site Oxfordshire United Kingdom OX3 7LJ
    113 Pfizer Investigational Site Southampton United Kingdom SO16 6YD

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT00246571
    Other Study ID Numbers:
    • A6181077
    First Posted:
    Oct 30, 2005
    Last Update Posted:
    Jul 12, 2012
    Last Verified:
    Jul 1, 2012
    Additional relevant MeSH terms:
    Breast Neoplasms
    Sunitinib

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Sunitinib Standard of Care
    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

    Baseline Characteristics

    Arm/Group Title Sunitinib Standard of Care Total
    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 Participants 113 104 217
    Age, Customized (Number) [Number]
    Less than 65 years
    103
    91.2%
    90
    86.5%
    193
    88.9%
    Greater than or equal to 65 years
    10
    8.8%
    14
    13.5%
    24
    11.1%
    Sex: Female, Male (Count of Participants)
    Female
    113
    100%
    104
    100%
    217
    100%
    Male
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Progression-Free Survival (PFS)
    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)

    Outcome Measure Data

    Analysis Population Description
    Intent-to-Treat (ITT) population: all participants who were randomized.
    Arm/Group Title Sunitinib Standard of Care
    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.
    Measure Participants 113 104
    Core radiology laboratory assessment
    2.0
    2.7
    Investigator's assessment
    1.7
    2.5
    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
    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
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.2030
    Confidence Interval (2-Sided) 95%
    0.8889 to 1.6280
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    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
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.1598
    Confidence Interval (2-Sided) 95%
    0.8703 to 1.5457
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Proportion of Participants With Objective Response
    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)

    Outcome Measure Data

    Analysis Population Description
    ITT population
    Arm/Group Title Sunitinib Standard of Care
    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.
    Measure Participants 113 104
    Core radiology laboratory assessment
    2.7
    2.4%
    6.7
    6.4%
    Investigator's assessment
    8.8
    7.8%
    11.5
    11.1%
    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
    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
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.38
    Confidence Interval (2-Sided) 95%
    0.06 to 1.71
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    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
    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
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 0.74
    Confidence Interval (2-Sided) 95%
    0.27 to 1.98
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Duration of Response (DR)
    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

    Outcome Measure Data

    Analysis Population Description
    ITT population
    Arm/Group Title Sunitinib Standard of Care
    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.
    Measure Participants 113 104
    Core radiology assessment (n=3,7)
    3.0
    NA
    Investigator's assessment (n=10,12)
    3.6
    4.6
    4. Secondary Outcome
    Title Survival Probability at 1 Year
    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)

    Outcome Measure Data

    Analysis Population Description
    ITT population
    Arm/Group Title Sunitinib Standard of Care
    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.
    Measure Participants 113 104
    Number (95% Confidence Interval) [ratio]
    0.376
    0.446
    5. Secondary Outcome
    Title Overall Survival (OS)
    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)

    Outcome Measure Data

    Analysis Population Description
    ITT population
    Arm/Group Title Sunitinib Standard of Care
    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.
    Measure Participants 113 104
    Median (95% Confidence Interval) [months]
    9.4
    10.5
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sunitinib, Standard of Care
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    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
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 1.1599
    Confidence Interval (2-Sided) 95%
    0.8648 to 1.5558
    Parameter Dispersion Type:
    Value:
    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)
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 0 0
    7. Secondary Outcome
    Title HRQoL and Disease Related Symptoms as Measured by EORTC-QLQ-C30 Breast Cancer Module (BR23) Score
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 0 0
    8. Secondary Outcome
    Title Observed Plasma Trough Concentrations (Ctrough) of Sunitinib
    Description
    Time Frame Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3

    Outcome Measure Data

    Analysis Population Description
    ITT population. n = number of participants with available data for those time points.
    Arm/Group Title Sunitinib
    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.
    Measure Participants 54
    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)
    Description
    Time Frame Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3

    Outcome Measure Data

    Analysis Population Description
    ITT population. n = number of participants with available data for those time points.
    Arm/Group Title Sunitinib
    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.
    Measure Participants 54
    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)
    Description
    Time Frame Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3

    Outcome Measure Data

    Analysis Population Description
    ITT population. n = number of participants with available data for those time points.
    Arm/Group Title Sunitinib
    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.
    Measure Participants 54
    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
    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

    Outcome Measure Data

    Analysis Population Description
    ITT population. n = number of participants with available data for those time points.
    Arm/Group Title Sunitinib
    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.
    Measure Participants 44
    Cycle 1, Day 1 (n=ND)
    NA
    (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)
    12. Secondary Outcome
    Title Dose-corrected Ctrough of SU012662 (Metabolite of Sunitinib)
    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

    Outcome Measure Data

    Analysis Population Description
    ITT population. n = number of participants with available data for those time points.
    Arm/Group Title Sunitinib
    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.
    Measure Participants 54
    Cycle 1, Day 1 (n=ND)
    NA
    (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)
    13. Secondary Outcome
    Title Dose-corrected Ctrough of Total Drug (Sunitinib + SU012662)
    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

    Outcome Measure Data

    Analysis Population Description
    ITT population. n = number of participants with available data for those time points.
    Arm/Group Title Sunitinib
    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.
    Measure Participants 44
    Cycle 1, Day 1 (n=ND)
    NA
    (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)
    14. Secondary Outcome
    Title Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2)
    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

    Outcome Measure Data

    Analysis Population Description
    ITT population. This outcome measure was not analyzed.
    Arm/Group Title Sunitinib Standard of Care
    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.
    Measure Participants 0 0
    15. Secondary Outcome
    Title Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (sVEGFR3)
    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

    Outcome Measure Data

    Analysis Population Description
    ITT population. n = participants with available data at that time point.
    Arm/Group Title Sunitinib Standard of Care
    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.
    Measure Participants 83 64
    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)
    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

    Outcome Measure Data

    Analysis Population Description
    ITT population. n = participants with available data at that time point.
    Arm/Group Title Sunitinib Standard of Care
    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.
    Measure Participants 83 66
    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)
    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

    Outcome Measure Data

    Analysis Population Description
    ITT population. n = participants with available data at that time point.
    Arm/Group Title Sunitinib Standard of Care
    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.
    Measure Participants 15 11
    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
    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

    Outcome Measure Data

    Analysis Population Description
    ITT population. n = participants with available data at that time point.
    Arm/Group Title Sunitinib Standard of Care
    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.
    Measure Participants 83 64
    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)
    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

    Outcome Measure Data

    Analysis Population Description
    ITT population. n = participants with available data at that time point.
    Arm/Group Title Sunitinib Standard of Care
    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.
    Measure Participants 42 48
    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)
    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

    Outcome Measure Data

    Analysis Population Description
    ITT population. n = participants with available data at that time point.
    Arm/Group Title Sunitinib Standard of Care
    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.
    Measure Participants 20 17
    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)

    Adverse Events

    Time Frame
    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
    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 (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Sunitinib Standard of Care
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 40/110 (36.4%) 21/103 (20.4%)
    Blood and lymphatic system disorders
    Anaemia 3/110 (2.7%) 0/103 (0%)
    Disseminated intravascular coagulation 1/110 (0.9%) 0/103 (0%)
    Febrile neutropenia 2/110 (1.8%) 2/103 (1.9%)
    Leukopenia 0/110 (0%) 1/103 (1%)
    Pancytopenia 1/110 (0.9%) 0/103 (0%)
    Thrombocytopenia 2/110 (1.8%) 0/103 (0%)
    Cardiac disorders
    Atrial fibrillation 1/110 (0.9%) 1/103 (1%)
    Cardiac arrest 1/110 (0.9%) 0/103 (0%)
    Cardiac failure 1/110 (0.9%) 0/103 (0%)
    Cardiopulmonary failure 1/110 (0.9%) 0/103 (0%)
    Myocardial ischaemia 1/110 (0.9%) 0/103 (0%)
    Supraventricular tachycardia 0/110 (0%) 1/103 (1%)
    Gastrointestinal disorders
    Abdominal pain 4/110 (3.6%) 1/103 (1%)
    Abdominal pain lower 1/110 (0.9%) 0/103 (0%)
    Abdominal pain upper 1/110 (0.9%) 0/103 (0%)
    Constipation 1/110 (0.9%) 0/103 (0%)
    Faeces discoloured 1/110 (0.9%) 0/103 (0%)
    Gastritis 0/110 (0%) 1/103 (1%)
    Mouth ulceration 1/110 (0.9%) 0/103 (0%)
    Nausea 1/110 (0.9%) 2/103 (1.9%)
    Pancreatitis 1/110 (0.9%) 0/103 (0%)
    Vomiting 2/110 (1.8%) 3/103 (2.9%)
    Ascites 1/110 (0.9%) 0/103 (0%)
    General disorders
    Asthenia 4/110 (3.6%) 1/103 (1%)
    Axillary pain 1/110 (0.9%) 0/103 (0%)
    Disease progression 16/110 (14.5%) 3/103 (2.9%)
    Fatigue 2/110 (1.8%) 0/103 (0%)
    Hyperthermia 1/110 (0.9%) 0/103 (0%)
    Mucosal inflammation 0/110 (0%) 1/103 (1%)
    Pyrexia 0/110 (0%) 1/103 (1%)
    Hepatobiliary disorders
    Acute hepatic failure 1/110 (0.9%) 0/103 (0%)
    Liver disorder 0/110 (0%) 1/103 (1%)
    Infections and infestations
    Bronchopneumonia 1/110 (0.9%) 0/103 (0%)
    Neutropenic sepsis 0/110 (0%) 1/103 (1%)
    Pyelonephritis 0/110 (0%) 1/103 (1%)
    Staphylococcal infection 1/110 (0.9%) 0/103 (0%)
    Urinary tract infection 0/110 (0%) 1/103 (1%)
    Urosepsis 1/110 (0.9%) 1/103 (1%)
    Injury, poisoning and procedural complications
    Concussion 1/110 (0.9%) 0/103 (0%)
    Femur fracture 0/110 (0%) 1/103 (1%)
    Investigations
    Blood bilirubin increased 1/110 (0.9%) 0/103 (0%)
    Blood creatinine increased 1/110 (0.9%) 0/103 (0%)
    Lipase increased 1/110 (0.9%) 0/103 (0%)
    Metabolism and nutrition disorders
    Failure to thrive 1/110 (0.9%) 0/103 (0%)
    Hyperglycaemia 0/110 (0%) 1/103 (1%)
    Musculoskeletal and connective tissue disorders
    Back pain 0/110 (0%) 1/103 (1%)
    Bone pain 1/110 (0.9%) 0/103 (0%)
    Neck pain 1/110 (0.9%) 0/103 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Lymphangiosis carcinomatosa 1/110 (0.9%) 0/103 (0%)
    Malignant pleural effusion 1/110 (0.9%) 0/103 (0%)
    Nervous system disorders
    Headache 2/110 (1.8%) 0/103 (0%)
    Ischaemic stroke 0/110 (0%) 1/103 (1%)
    Migraine 1/110 (0.9%) 0/103 (0%)
    Presyncope 0/110 (0%) 1/103 (1%)
    Transient ischaemic attack 0/110 (0%) 1/103 (1%)
    Psychiatric disorders
    Agitation 1/110 (0.9%) 0/103 (0%)
    Confusional state 1/110 (0.9%) 0/103 (0%)
    Depression 1/110 (0.9%) 0/103 (0%)
    Hallucination, visual 1/110 (0.9%) 0/103 (0%)
    Suicide attempt 0/110 (0%) 1/103 (1%)
    Renal and urinary disorders
    Hydronephrosis 1/110 (0.9%) 0/103 (0%)
    Cystitis haemorrhagic 0/110 (0%) 1/103 (1%)
    Reproductive system and breast disorders
    Breast pain 1/110 (0.9%) 0/103 (0%)
    Respiratory, thoracic and mediastinal disorders
    Asthma 1/110 (0.9%) 0/103 (0%)
    Dyspnoea 5/110 (4.5%) 1/103 (1%)
    Dyspnoea exertional 1/110 (0.9%) 0/103 (0%)
    Haemoptysis 0/110 (0%) 1/103 (1%)
    Hydrothorax 0/110 (0%) 1/103 (1%)
    Hypoxia 1/110 (0.9%) 1/103 (1%)
    Lung infiltration 1/110 (0.9%) 0/103 (0%)
    Pleural effusion 3/110 (2.7%) 3/103 (2.9%)
    Pleuritic pain 1/110 (0.9%) 0/103 (0%)
    Pneumothorax 3/110 (2.7%) 0/103 (0%)
    Pulmonary embolism 3/110 (2.7%) 0/103 (0%)
    Surgical and medical procedures
    Ureteral stent insertion 1/110 (0.9%) 0/103 (0%)
    Vascular disorders
    Deep vein thrombosis 0/110 (0%) 1/103 (1%)
    Hypertension 2/110 (1.8%) 0/103 (0%)
    Hypotension 1/110 (0.9%) 1/103 (1%)
    Thrombosis 1/110 (0.9%) 1/103 (1%)
    Other (Not Including Serious) Adverse Events
    Sunitinib Standard of Care
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 109/110 (99.1%) 98/103 (95.1%)
    Blood and lymphatic system disorders
    Anaemia 15/110 (13.6%) 17/103 (16.5%)
    Leukopenia 24/110 (21.8%) 8/103 (7.8%)
    Neutropenia 34/110 (30.9%) 24/103 (23.3%)
    Thrombocytopenia 27/110 (24.5%) 7/103 (6.8%)
    Hypercoagulation 1/110 (0.9%) 0/103 (0%)
    Lymphadenopathy 2/110 (1.8%) 0/103 (0%)
    Lymphopenia 1/110 (0.9%) 1/103 (1%)
    Cardiac disorders
    Atrial fibrillation 2/110 (1.8%) 0/103 (0%)
    Left ventricular dysfunction 1/110 (0.9%) 0/103 (0%)
    Palpitations 1/110 (0.9%) 2/103 (1.9%)
    Tachycardia 2/110 (1.8%) 2/103 (1.9%)
    Ear and labyrinth disorders
    Deafness unilateral 1/110 (0.9%) 0/103 (0%)
    Ear discomfort 1/110 (0.9%) 0/103 (0%)
    Ear pain 2/110 (1.8%) 1/103 (1%)
    Tinnitus 0/110 (0%) 1/103 (1%)
    Vertigo 3/110 (2.7%) 2/103 (1.9%)
    Endocrine disorders
    Hypothyroidism 15/110 (13.6%) 3/103 (2.9%)
    Hyperthyroidism 0/110 (0%) 1/103 (1%)
    Eye disorders
    Conjunctivitis 6/110 (5.5%) 3/103 (2.9%)
    Eye oedema 0/110 (0%) 1/103 (1%)
    Eye swelling 1/110 (0.9%) 0/103 (0%)
    Eyelid oedema 2/110 (1.8%) 0/103 (0%)
    Eyelid pain 1/110 (0.9%) 0/103 (0%)
    Eyelid ptosis 0/110 (0%) 1/103 (1%)
    Glare 0/110 (0%) 1/103 (1%)
    Keratoconjunctivitis sicca 1/110 (0.9%) 0/103 (0%)
    Lacrimation increased 2/110 (1.8%) 3/103 (2.9%)
    Periorbital oedema 6/110 (5.5%) 1/103 (1%)
    Photophobia 1/110 (0.9%) 0/103 (0%)
    Vision blurred 4/110 (3.6%) 0/103 (0%)
    Visual impairment 1/110 (0.9%) 1/103 (1%)
    Gastrointestinal disorders
    Abdominal pain 12/110 (10.9%) 8/103 (7.8%)
    Abdominal pain upper 10/110 (9.1%) 5/103 (4.9%)
    Constipation 13/110 (11.8%) 17/103 (16.5%)
    Diarrhoea 50/110 (45.5%) 26/103 (25.2%)
    Dyspepsia 19/110 (17.3%) 6/103 (5.8%)
    Nausea 52/110 (47.3%) 36/103 (35%)
    Stomatitis 15/110 (13.6%) 6/103 (5.8%)
    Vomiting 26/110 (23.6%) 17/103 (16.5%)
    Abdominal discomfort 0/110 (0%) 1/103 (1%)
    Abdominal distension 2/110 (1.8%) 1/103 (1%)
    Abdominal pain lower 1/110 (0.9%) 1/103 (1%)
    Aphthous stomatitis 0/110 (0%) 1/103 (1%)
    Breath odour 1/110 (0.9%) 0/103 (0%)
    Cheilitis 2/110 (1.8%) 0/103 (0%)
    Dental caries 0/110 (0%) 1/103 (1%)
    Dry mouth 6/110 (5.5%) 3/103 (2.9%)
    Dysphagia 1/110 (0.9%) 2/103 (1.9%)
    Enteritis 1/110 (0.9%) 0/103 (0%)
    Flatulence 3/110 (2.7%) 2/103 (1.9%)
    Gastritis 2/110 (1.8%) 1/103 (1%)
    Gastrooesophageal reflux disease 6/110 (5.5%) 1/103 (1%)
    Gingival bleeding 5/110 (4.5%) 0/103 (0%)
    Gingival pain 0/110 (0%) 1/103 (1%)
    Gingivitis 1/110 (0.9%) 0/103 (0%)
    Glossodynia 4/110 (3.6%) 0/103 (0%)
    Haemorrhoidal haemorrhage 1/110 (0.9%) 0/103 (0%)
    Haemorrhoids 1/110 (0.9%) 0/103 (0%)
    Intestinal obstruction 1/110 (0.9%) 0/103 (0%)
    Mouth ulceration 2/110 (1.8%) 0/103 (0%)
    Oral mucosal erythema 1/110 (0.9%) 0/103 (0%)
    Oral pain 7/110 (6.4%) 0/103 (0%)
    Painful defaecation 1/110 (0.9%) 0/103 (0%)
    Rectal haemorrhage 1/110 (0.9%) 0/103 (0%)
    Reflux oesophagitis 2/110 (1.8%) 0/103 (0%)
    Tongue disorder 2/110 (1.8%) 0/103 (0%)
    Tooth discolouration 1/110 (0.9%) 0/103 (0%)
    Toothache 1/110 (0.9%) 0/103 (0%)
    General disorders
    Asthenia 32/110 (29.1%) 15/103 (14.6%)
    Chest pain 9/110 (8.2%) 7/103 (6.8%)
    Fatigue 41/110 (37.3%) 38/103 (36.9%)
    Mucosal inflammation 30/110 (27.3%) 16/103 (15.5%)
    Oedema peripheral 7/110 (6.4%) 7/103 (6.8%)
    Pyrexia 9/110 (8.2%) 17/103 (16.5%)
    Axillary pain 1/110 (0.9%) 0/103 (0%)
    Bloody discharge 0/110 (0%) 1/103 (1%)
    Chills 3/110 (2.7%) 0/103 (0%)
    Device occlusion 1/110 (0.9%) 0/103 (0%)
    Face oedema 2/110 (1.8%) 2/103 (1.9%)
    Generalised oedema 1/110 (0.9%) 0/103 (0%)
    Influenza like illness 2/110 (1.8%) 2/103 (1.9%)
    Localised oedema 1/110 (0.9%) 0/103 (0%)
    Nodule 1/110 (0.9%) 0/103 (0%)
    Non-cardiac chest pain 1/110 (0.9%) 2/103 (1.9%)
    Oedema 3/110 (2.7%) 2/103 (1.9%)
    Pain 1/110 (0.9%) 5/103 (4.9%)
    Therapeutic response unexpected 1/110 (0.9%) 0/103 (0%)
    Ulcer 1/110 (0.9%) 0/103 (0%)
    Hepatobiliary disorders
    Caput medusae 1/110 (0.9%) 0/103 (0%)
    Cholestasis 1/110 (0.9%) 0/103 (0%)
    Hepatic failure 0/110 (0%) 1/103 (1%)
    Hepatic pain 0/110 (0%) 1/103 (1%)
    Hepatitis 1/110 (0.9%) 0/103 (0%)
    Hyperbilirubinaemia 1/110 (0.9%) 0/103 (0%)
    Jaundice 1/110 (0.9%) 0/103 (0%)
    Immune system disorders
    Contrast media allergy 2/110 (1.8%) 0/103 (0%)
    Hypersensitivity 1/110 (0.9%) 0/103 (0%)
    Infections and infestations
    Bacteriuria 1/110 (0.9%) 0/103 (0%)
    Breast infection 1/110 (0.9%) 2/103 (1.9%)
    Bronchitis 0/110 (0%) 1/103 (1%)
    Candidiasis 1/110 (0.9%) 0/103 (0%)
    Cellulitis 0/110 (0%) 1/103 (1%)
    Chest wall abscess 1/110 (0.9%) 0/103 (0%)
    Cystitis 4/110 (3.6%) 0/103 (0%)
    Device related infection 1/110 (0.9%) 0/103 (0%)
    Ear infection 0/110 (0%) 1/103 (1%)
    Erysipelas 0/110 (0%) 2/103 (1.9%)
    Eye infection 0/110 (0%) 1/103 (1%)
    Fungal infection 1/110 (0.9%) 1/103 (1%)
    Fungal skin infection 1/110 (0.9%) 0/103 (0%)
    Gastroenteritis 1/110 (0.9%) 0/103 (0%)
    Gastroenteritis viral 0/110 (0%) 1/103 (1%)
    Herpes simplex 2/110 (1.8%) 0/103 (0%)
    Herpes virus infection 1/110 (0.9%) 0/103 (0%)
    Herpes zoster 1/110 (0.9%) 0/103 (0%)
    Infection 2/110 (1.8%) 1/103 (1%)
    Influenza 1/110 (0.9%) 5/103 (4.9%)
    Localised infection 1/110 (0.9%) 1/103 (1%)
    Lymph gland infection 1/110 (0.9%) 0/103 (0%)
    Nasopharyngitis 2/110 (1.8%) 4/103 (3.9%)
    Oral candidiasis 2/110 (1.8%) 1/103 (1%)
    Oral herpes 2/110 (1.8%) 2/103 (1.9%)
    Paronychia 0/110 (0%) 2/103 (1.9%)
    Pharyngitis 1/110 (0.9%) 0/103 (0%)
    Pneumonia 1/110 (0.9%) 0/103 (0%)
    Post procedural infection 0/110 (0%) 1/103 (1%)
    Respiratory tract infection 0/110 (0%) 1/103 (1%)
    Rhinitis 1/110 (0.9%) 2/103 (1.9%)
    Sinusitis 1/110 (0.9%) 4/103 (3.9%)
    Skin candida 0/110 (0%) 1/103 (1%)
    Skin infection 3/110 (2.7%) 1/103 (1%)
    Subcutaneous abscess 1/110 (0.9%) 0/103 (0%)
    Tinea pedis 1/110 (0.9%) 0/103 (0%)
    Tooth abscess 1/110 (0.9%) 1/103 (1%)
    Tooth infection 1/110 (0.9%) 0/103 (0%)
    Upper respiratory tract infection 2/110 (1.8%) 4/103 (3.9%)
    Urinary tract infection 2/110 (1.8%) 5/103 (4.9%)
    Vaginal infection 1/110 (0.9%) 0/103 (0%)
    Vulvovaginal candidiasis 1/110 (0.9%) 1/103 (1%)
    Wound infection 1/110 (0.9%) 0/103 (0%)
    Injury, poisoning and procedural complications
    Contusion 5/110 (4.5%) 2/103 (1.9%)
    Joint injury 0/110 (0%) 1/103 (1%)
    Open wound 0/110 (0%) 1/103 (1%)
    Post procedural haemorrhage 1/110 (0.9%) 0/103 (0%)
    Radiation skin injury 0/110 (0%) 1/103 (1%)
    Thermal burn 2/110 (1.8%) 0/103 (0%)
    Wound dehiscence 1/110 (0.9%) 0/103 (0%)
    Investigations
    Alanine aminotransferase increased 6/110 (5.5%) 5/103 (4.9%)
    Aspartate aminotransferase increased 8/110 (7.3%) 5/103 (4.9%)
    Platelet count decreased 14/110 (12.7%) 1/103 (1%)
    Weight decreased 12/110 (10.9%) 3/103 (2.9%)
    Activated partial thromboplastin time prolonged 1/110 (0.9%) 0/103 (0%)
    Blood alkaline phosphatase increased 6/110 (5.5%) 0/103 (0%)
    Blood bilirubin increased 2/110 (1.8%) 0/103 (0%)
    Blood lactate dehydrogenase increased 2/110 (1.8%) 0/103 (0%)
    Blood magnesium decreased 2/110 (1.8%) 0/103 (0%)
    Blood thyroid stimulating hormone increased 1/110 (0.9%) 0/103 (0%)
    Ejection fraction decreased 0/110 (0%) 1/103 (1%)
    Electrocardiogram ST segment elevation 0/110 (0%) 1/103 (1%)
    Gamma-glutamyltransferase increased 1/110 (0.9%) 1/103 (1%)
    Haemoglobin decreased 3/110 (2.7%) 1/103 (1%)
    Hypophonesis 1/110 (0.9%) 1/103 (1%)
    Neutrophil count decreased 5/110 (4.5%) 4/103 (3.9%)
    Renal function test abnormal 1/110 (0.9%) 0/103 (0%)
    Urine output decreased 1/110 (0.9%) 0/103 (0%)
    Weight increased 1/110 (0.9%) 1/103 (1%)
    White blood cell count decreased 6/110 (5.5%) 3/103 (2.9%)
    Metabolism and nutrition disorders
    Decreased appetite 29/110 (26.4%) 12/103 (11.7%)
    Hypokalaemia 5/110 (4.5%) 6/103 (5.8%)
    Dehydration 5/110 (4.5%) 1/103 (1%)
    Fluid retention 1/110 (0.9%) 1/103 (1%)
    Hypercalcaemia 0/110 (0%) 1/103 (1%)
    Hyperglycaemia 2/110 (1.8%) 2/103 (1.9%)
    Hypertriglyceridaemia 0/110 (0%) 1/103 (1%)
    Hyperuricaemia 1/110 (0.9%) 0/103 (0%)
    Hypoalbuminaemia 4/110 (3.6%) 0/103 (0%)
    Hypocalcaemia 4/110 (3.6%) 2/103 (1.9%)
    Hypoglycaemia 1/110 (0.9%) 0/103 (0%)
    Hypomagnesaemia 3/110 (2.7%) 3/103 (2.9%)
    Hyponatraemia 2/110 (1.8%) 0/103 (0%)
    Hypophosphataemia 1/110 (0.9%) 1/103 (1%)
    Hyposideraemia 0/110 (0%) 1/103 (1%)
    Hypovolaemia 0/110 (0%) 1/103 (1%)
    Tetany 0/110 (0%) 1/103 (1%)
    Vitamin A deficiency 0/110 (0%) 1/103 (1%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 9/110 (8.2%) 2/103 (1.9%)
    Back pain 12/110 (10.9%) 9/103 (8.7%)
    Musculoskeletal chest pain 12/110 (10.9%) 6/103 (5.8%)
    Musculoskeletal pain 7/110 (6.4%) 9/103 (8.7%)
    Neck pain 8/110 (7.3%) 4/103 (3.9%)
    Pain in extremity 19/110 (17.3%) 9/103 (8.7%)
    Arthritis 0/110 (0%) 1/103 (1%)
    Bone pain 4/110 (3.6%) 5/103 (4.9%)
    Groin pain 1/110 (0.9%) 0/103 (0%)
    Joint stiffness 1/110 (0.9%) 0/103 (0%)
    Joint swelling 1/110 (0.9%) 0/103 (0%)
    Muscle spasms 5/110 (4.5%) 5/103 (4.9%)
    Muscular weakness 1/110 (0.9%) 1/103 (1%)
    Myalgia 4/110 (3.6%) 4/103 (3.9%)
    Nuchal rigidity 1/110 (0.9%) 0/103 (0%)
    Osteoporosis 0/110 (0%) 1/103 (1%)
    Pain in jaw 2/110 (1.8%) 1/103 (1%)
    Periarthritis 1/110 (0.9%) 0/103 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Infected neoplasm 0/110 (0%) 1/103 (1%)
    Lymphangiosis carcinomatosa 1/110 (0.9%) 0/103 (0%)
    Malignant pleural effusion 0/110 (0%) 1/103 (1%)
    Neoplasm 1/110 (0.9%) 0/103 (0%)
    Tumour pain 1/110 (0.9%) 1/103 (1%)
    Nervous system disorders
    Dizziness 6/110 (5.5%) 6/103 (5.8%)
    Dysgeusia 23/110 (20.9%) 5/103 (4.9%)
    Headache 19/110 (17.3%) 13/103 (12.6%)
    Ageusia 2/110 (1.8%) 0/103 (0%)
    Amnesia 2/110 (1.8%) 0/103 (0%)
    Aphasia 0/110 (0%) 1/103 (1%)
    Ataxia 2/110 (1.8%) 0/103 (0%)
    Burning sensation 1/110 (0.9%) 0/103 (0%)
    Cognitive disorder 1/110 (0.9%) 0/103 (0%)
    Depressed level of consciousness 1/110 (0.9%) 0/103 (0%)
    Dysarthria 1/110 (0.9%) 1/103 (1%)
    Epilepsy 0/110 (0%) 1/103 (1%)
    Hemiplegia 1/110 (0.9%) 0/103 (0%)
    Hyperaesthesia 1/110 (0.9%) 0/103 (0%)
    Hypoaesthesia 1/110 (0.9%) 2/103 (1.9%)
    IIIrd nerve paralysis 1/110 (0.9%) 0/103 (0%)
    Lethargy 1/110 (0.9%) 0/103 (0%)
    Memory impairment 0/110 (0%) 1/103 (1%)
    Migraine 0/110 (0%) 2/103 (1.9%)
    Neuralgia 3/110 (2.7%) 1/103 (1%)
    Neuropathy peripheral 4/110 (3.6%) 4/103 (3.9%)
    Neurotoxicity 0/110 (0%) 1/103 (1%)
    Paraesthesia 3/110 (2.7%) 5/103 (4.9%)
    Parosmia 1/110 (0.9%) 1/103 (1%)
    Peripheral sensory neuropathy 1/110 (0.9%) 4/103 (3.9%)
    Presyncope 0/110 (0%) 1/103 (1%)
    Sensory disturbance 0/110 (0%) 1/103 (1%)
    Sinus headache 0/110 (0%) 1/103 (1%)
    Somnolence 2/110 (1.8%) 0/103 (0%)
    Spinal cord compression 0/110 (0%) 1/103 (1%)
    Syncope 1/110 (0.9%) 1/103 (1%)
    Tongue paralysis 0/110 (0%) 1/103 (1%)
    Psychiatric disorders
    Anxiety 9/110 (8.2%) 4/103 (3.9%)
    Insomnia 7/110 (6.4%) 10/103 (9.7%)
    Agitation 0/110 (0%) 1/103 (1%)
    Confusional state 1/110 (0.9%) 1/103 (1%)
    Depressed mood 0/110 (0%) 1/103 (1%)
    Depression 3/110 (2.7%) 4/103 (3.9%)
    Mental status changes 1/110 (0.9%) 0/103 (0%)
    Renal and urinary disorders
    Calculus ureteric 1/110 (0.9%) 0/103 (0%)
    Chromaturia 1/110 (0.9%) 0/103 (0%)
    Dysuria 2/110 (1.8%) 2/103 (1.9%)
    Haematuria 1/110 (0.9%) 0/103 (0%)
    Haemorrhage urinary tract 1/110 (0.9%) 0/103 (0%)
    Micturition urgency 1/110 (0.9%) 0/103 (0%)
    Pollakiuria 2/110 (1.8%) 0/103 (0%)
    Polyuria 1/110 (0.9%) 0/103 (0%)
    Proteinuria 3/110 (2.7%) 0/103 (0%)
    Renal pain 1/110 (0.9%) 0/103 (0%)
    Urinary incontinence 1/110 (0.9%) 0/103 (0%)
    Reproductive system and breast disorders
    Breast pain 7/110 (6.4%) 5/103 (4.9%)
    Breast discolouration 1/110 (0.9%) 0/103 (0%)
    Breast disorder 1/110 (0.9%) 0/103 (0%)
    Breast haemorrhage 1/110 (0.9%) 0/103 (0%)
    Genital haemorrhage 1/110 (0.9%) 0/103 (0%)
    Menstruation irregular 1/110 (0.9%) 0/103 (0%)
    Pelvic pain 2/110 (1.8%) 0/103 (0%)
    Perineal pain 1/110 (0.9%) 0/103 (0%)
    Vaginal haemorrhage 2/110 (1.8%) 0/103 (0%)
    Respiratory, thoracic and mediastinal disorders
    Cough 19/110 (17.3%) 13/103 (12.6%)
    Dyspnoea 25/110 (22.7%) 13/103 (12.6%)
    Epistaxis 11/110 (10%) 4/103 (3.9%)
    Pleural effusion 6/110 (5.5%) 5/103 (4.9%)
    Dysphonia 0/110 (0%) 2/103 (1.9%)
    Dyspnoea exertional 1/110 (0.9%) 2/103 (1.9%)
    Haemoptysis 1/110 (0.9%) 0/103 (0%)
    Hiccups 2/110 (1.8%) 0/103 (0%)
    Hydrothorax 1/110 (0.9%) 1/103 (1%)
    Hypoxia 2/110 (1.8%) 1/103 (1%)
    Laryngeal oedema 1/110 (0.9%) 0/103 (0%)
    Lung disorder 1/110 (0.9%) 0/103 (0%)
    Lung infiltration 1/110 (0.9%) 0/103 (0%)
    Nasal dryness 1/110 (0.9%) 0/103 (0%)
    Oropharyngeal pain 2/110 (1.8%) 4/103 (3.9%)
    Paranasal sinus hypersecretion 0/110 (0%) 2/103 (1.9%)
    Pleuritic pain 1/110 (0.9%) 0/103 (0%)
    Pneumothorax 1/110 (0.9%) 0/103 (0%)
    Rales 0/110 (0%) 1/103 (1%)
    Respiratory distress 1/110 (0.9%) 0/103 (0%)
    Respiratory tract congestion 1/110 (0.9%) 0/103 (0%)
    Rhinorrhoea 0/110 (0%) 2/103 (1.9%)
    Sinus congestion 1/110 (0.9%) 0/103 (0%)
    Tachypnoea 0/110 (0%) 1/103 (1%)
    Skin and subcutaneous tissue disorders
    Erythema 11/110 (10%) 3/103 (2.9%)
    Palmar-plantar erythrodysaesthesia syndrome 27/110 (24.5%) 27/103 (26.2%)
    Rash 10/110 (9.1%) 1/103 (1%)
    Skin discolouration 18/110 (16.4%) 0/103 (0%)
    Acne 1/110 (0.9%) 0/103 (0%)
    Alopecia 4/110 (3.6%) 6/103 (5.8%)
    Angioedema 1/110 (0.9%) 0/103 (0%)
    Blister 3/110 (2.7%) 1/103 (1%)
    Dermatitis 1/110 (0.9%) 0/103 (0%)
    Dermatitis acneiform 2/110 (1.8%) 0/103 (0%)
    Dermatitis allergic 1/110 (0.9%) 1/103 (1%)
    Dermatitis exfoliative 1/110 (0.9%) 0/103 (0%)
    Dry skin 7/110 (6.4%) 1/103 (1%)
    Ecchymosis 2/110 (1.8%) 0/103 (0%)
    Eczema 1/110 (0.9%) 0/103 (0%)
    Hair colour changes 4/110 (3.6%) 0/103 (0%)
    Hyperkeratosis 3/110 (2.7%) 0/103 (0%)
    Increased tendency to bruise 0/110 (0%) 1/103 (1%)
    Madarosis 1/110 (0.9%) 0/103 (0%)
    Nail disorder 3/110 (2.7%) 4/103 (3.9%)
    Nail toxicity 0/110 (0%) 2/103 (1.9%)
    Onycholysis 1/110 (0.9%) 1/103 (1%)
    Palmar erythema 1/110 (0.9%) 0/103 (0%)
    Petechiae 1/110 (0.9%) 1/103 (1%)
    Plantar erythema 1/110 (0.9%) 0/103 (0%)
    Pruritus 7/110 (6.4%) 2/103 (1.9%)
    Purpura 0/110 (0%) 1/103 (1%)
    Rash erythematous 0/110 (0%) 1/103 (1%)
    Rash macular 0/110 (0%) 1/103 (1%)
    Rash pruritic 0/110 (0%) 1/103 (1%)
    Scar 1/110 (0.9%) 0/103 (0%)
    Skin hyperpigmentation 4/110 (3.6%) 2/103 (1.9%)
    Skin hypopigmentation 1/110 (0.9%) 0/103 (0%)
    Skin irritation 1/110 (0.9%) 0/103 (0%)
    Skin lesion 4/110 (3.6%) 0/103 (0%)
    Skin odour abnormal 1/110 (0.9%) 0/103 (0%)
    Skin toxicity 1/110 (0.9%) 1/103 (1%)
    Skin ulcer 1/110 (0.9%) 0/103 (0%)
    Telangiectasia 1/110 (0.9%) 0/103 (0%)
    Yellow skin 4/110 (3.6%) 0/103 (0%)
    Surgical and medical procedures
    Astringent therapy 1/110 (0.9%) 0/103 (0%)
    Vascular disorders
    Hypertension 26/110 (23.6%) 4/103 (3.9%)
    Lymphoedema 4/110 (3.6%) 7/103 (6.8%)
    Accelerated hypertension 1/110 (0.9%) 0/103 (0%)
    Axillary vein thrombosis 0/110 (0%) 1/103 (1%)
    Deep vein thrombosis 0/110 (0%) 2/103 (1.9%)
    Haematoma 1/110 (0.9%) 0/103 (0%)
    Haemorrhage 1/110 (0.9%) 0/103 (0%)
    Hot flush 5/110 (4.5%) 3/103 (2.9%)
    Hypotension 3/110 (2.7%) 2/103 (1.9%)
    Orthostatic hypotension 0/110 (0%) 1/103 (1%)
    Pelvic venous thrombosis 1/110 (0.9%) 0/103 (0%)
    Phlebitis superficial 0/110 (0%) 1/103 (1%)
    Raynaud's phenomenon 1/110 (0.9%) 0/103 (0%)
    Subclavian vein thrombosis 0/110 (0%) 1/103 (1%)
    Systolic hypertension 1/110 (0.9%) 0/103 (0%)
    Thrombophlebitis 0/110 (0%) 1/103 (1%)
    Thrombosis 1/110 (0.9%) 1/103 (1%)
    Vena cava thrombosis 0/110 (0%) 1/103 (1%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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

    Name/Title Pfizer ClinicalTrials.gov Call Center
    Organization Pfizer, Inc.
    Phone 1-800-718-1021
    Email ClinicalTrials.gov_Inquiries@pfizer.com
    Responsible Party:
    Pfizer
    ClinicalTrials.gov Identifier:
    NCT00246571
    Other Study ID Numbers:
    • A6181077
    First Posted:
    Oct 30, 2005
    Last Update Posted:
    Jul 12, 2012
    Last Verified:
    Jul 1, 2012