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SUN 1120: Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy

Sponsor
Pfizer (Industry)
Overall Status
Terminated
CT.gov ID
NCT00676650
Collaborator
(none)
873
Enrollment
205
Locations
2
Arms
41
Duration (Months)
4.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
873 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-Blind, Phase 3 Study Of Sunitinib Plus Prednisone Versus Prednisone In Patients With Progressive Metastatic Castration-Resistant Prostate Cancer After Failure Of A Docetaxel-Based Chemotherapy Regimen
Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Dec 1, 2011
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

Treatment Arm A - sunitinib + prednisone

Drug: Prednisone
5 mg BID, oral
Other Names:
  • Deltasone

    • Drug: sunitinib
    37.5 mg/day, oral, administered on a continuous daily dosing regimen
    Other Names:
  • Sutent, SU011248

    		•
    Placebo Comparator: B

    Treatment Arm B - placebo + prednisone

    Drug: Placebo
    37.5 mg/day, oral, administered on a continuous daily dosing regimen

    Drug: Prednisone
    5 mg BID, oral
    Other Names:
  • Deltasone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival (OS) [Baseline up to 32 months]

      OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus [-] date of randomization plus [+] 1) divided (/) 30.4.

    Secondary Outcome Measures

    1. Progression-Free Survival (PFS) [Baseline, every 8 weeks up to 123 weeks]

      PFS is the period from randomization until disease progression or death on study. PFS is censored on the date of last tumor assessment documenting absence of progressive disease. PFS (weeks) calculated as (first event date - randomization date + 1)/7.02

    2. Percent of Participants With Objective Response (OR) [Baseline, every 8 weeks up to 123 weeks]

      OR defined as the percent (%) of participants with confirmed Complete Response (CR) (disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to the full analysis population. Confirmed responses were those that persist on repeat imagining study >= 4 weeks after initial documentation of response.

    3. Duration of Response (DR) [Baseline, every 8 weeks up to 123 weeks]

      Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause - the date of the first CR or PR that was subsequently confirmed plus 1 divided by 7.02. DR calculated for the subgroup of participants with a confirmed objective tumor response

    4. Change From Baseline in Pain Severity [Day 1 through Day 7 every 28 days (every cycle) up to 29 months]

      Pain severity recorded on a numerical scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicated greater level of pain. The pain score for each cycle averaged for the 7 days.

    5. Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) [Baseline, every 4 weeks up to 123 weeks]

      FACT-P is a validated, self-administered instrument used to assess health-related quality of life and prostate cancer-specific symptoms. Scores ranged from 0 (not at all) to 4 (very much). It is 27-item FACT-General and 12 items for the prostate cancer specific concerns. The 27 items in FACT-G are grouped into 4 domains: physical well-being, social/family well-being, emotional well-being and functional well-being. The 12 prostate cancer symptoms items focus on pain (3 items), urination problems (3 items), sexual functions (2 items), weight loss, appetite, overall comfort, and bowel movement.

    6. Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score [Baseline, every 4 weeks up to 123 weeks]

      EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Overall scores range from 0 to 1, with lower scores representing a higher level of dysfunction.

    Eligibility Criteria

    Criteria

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

    • Histologically or cytologically confirmed adenocarcinoma of the prostate.

    • Progressive, metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy (resistant or intolerant).

    • Progressive disease based on PSA progression, RECIST, or positive bone scan.

    • ECOG 0 or 1.

    Exclusion Criteria:

    • Prior treatment with sunitinib and/or more than 1 prior chemotherapy regimen in the metastatic disease setting.

    • Chemotherapy within 3 weeks.

    • Impending complications from bone metastases.

    • Ongoing urinary obstruction.

    • Cardiac dysfunction, QTc >470 msec.

    • CNS involvement.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Decatur Alabama United States 35601
    2 Pfizer Investigational Site Huntsville Alabama United States 35801
    3 Pfizer Investigational Site Huntsville Alabama United States 35805
    4 Pfizer Investigational Site Anaheim California United States 92801
    5 Pfizer Investigational Site Encinitas California United States 92024
    6 Pfizer Investigational Site Glendale California United States 91206
    7 Pfizer Investigational Site La Jolla California United States 92037
    8 Pfizer Investigational Site Los Angeles California United States 90033
    9 Pfizer Investigational Site Modesto California United States 95355
    10 Pfizer Investigational Site Thousand Oaks California United States 91360
    11 Pfizer Investigational Site Thousands Oaks California United States 91360
    12 Pfizer Investigational Site Vista California United States 92083
    13 Pfizer Investigational Site Westlake Village California United States 91361
    14 Pfizer Investigational Site Denver Colorado United States 80205
    15 Pfizer Investigational Site Lafayette Colorado United States 80025
    16 Pfizer Investigational Site Gainesville Florida United States 32605
    17 Pfizer Investigational Site Orlando Florida United States 32806
    18 Pfizer Investigational Site Winter Park Florida United States 32789
    19 Pfizer Investigational Site Arlington Heights Illinois United States 60005
    20 Pfizer Investigational Site Niles Illinois United States 60714
    21 Pfizer Investigational Site Winfield Illinois United States 60190
    22 Pfizer Investigational Site Zion Illinois United States 60099
    23 Pfizer Investigational Site Carmel Indiana United States 46032
    24 Pfizer Investigational Site Fishers Indiana United States 46037
    25 Pfizer Investigational Site Greenfield Indiana United States 46140
    26 Pfizer Investigational Site Indianapolis Indiana United States 46219
    27 Pfizer Investigational Site Indianapolis Indiana United States 46227
    28 Pfizer Investigational Site Lafayette Indiana United States 47905
    29 Pfizer Investigational Site Louisville Kentucky United States 40207
    30 Pfizer Investigational Site Baltimore Maryland United States 21201
    31 Pfizer Investigational Site Boston Massachusetts United States 02114
    32 Pfizer Investigational Site Danvers Massachusetts United States 01923
    33 Pfizer Investigational Site Minneapolis Minnesota United States 55455
    34 Pfizer Investigational Site St. Cloud Minnesota United States 56303-5000
    35 Pfizer Investigational Site Corinth Mississippi United States 38834
    36 Pfizer Investigational Site Southaven Mississippi United States 38671
    37 Pfizer Investigational Site Lincoln Nebraska United States 68506
    38 Pfizer Investigational Site Omaha Nebraska United States 68114
    39 Pfizer Investigational Site Henderson Nevada United States 89052
    40 Pfizer Investigational Site Henderson Nevada United States 89074
    41 Pfizer Investigational Site Las Vegas Nevada United States 89128
    42 Pfizer Investigational Site Las Vegas Nevada United States 89148
    43 Pfizer Investigational Site Las Vegas Nevada United States 89169
    44 Pfizer Investigational Site Sewell New Jersey United States 08080
    45 Pfizer Investigational Site Bronx New York United States 10461
    46 Pfizer Investigational Site Bronx New York United States 10467-2401
    47 Pfizer Investigational Site New York New York United States 10032
    48 Pfizer Investigational Site Cary North Carolina United States 27518
    49 Pfizer Investigational Site Durham North Carolina United States 27710
    50 Pfizer Investigational Site Kernersville North Carolina United States 27284
    51 Pfizer Investigational Site Lexington North Carolina United States 27295
    52 Pfizer Investigational Site Mount Airy North Carolina United States 27030
    53 Pfizer Investigational Site North Wilkesboro North Carolina United States 28659
    54 Pfizer Investigational Site Raleigh North Carolina United States 27607
    55 Pfizer Investigational Site Raleigh North Carolina United States 27614
    56 Pfizer Investigational Site Winston-Salem North Carolina United States 27103
    57 Pfizer Investigational Site Bismarck North Dakota United States 58501
    58 Pfizer Investigational Site Cleveland Ohio United States 44106
    59 Pfizer Investigational Site Mayfield Heights Ohio United States 44124
    60 Pfizer Investigational Site Mentor Ohio United States 44060
    61 Pfizer Investigational Site Orange Village Ohio United States 44122
    62 Pfizer Investigational Site Westlake Ohio United States 44145
    63 Pfizer Investigational Site Eugene Oregon United States 97401
    64 Pfizer Investigational Site Springfield Oregon United States 97477
    65 Pfizer Investigational Site Clairton Pennsylvania United States 15025
    66 Pfizer Investigational Site Greensburg Pennsylvania United States 15601
    67 Pfizer Investigational Site Johnstown Pennsylvania United States 15901
    68 Pfizer Investigational Site Kingston Pennsylvania United States 18704
    69 Pfizer Investigational Site Lancaster Pennsylvania United States 17604
    70 Pfizer Investigational Site Pittsburgh Pennsylvania United States 15215
    71 Pfizer Investigational Site Pittsburgh Pennsylvania United States 15232
    72 Pfizer Investigational Site Pittsburgh Pennsylvania United States 15237
    73 Pfizer Investigational Site Pittsburgh Pennsylvania United States 15241
    74 Pfizer Investigational Site Uniontown Pennsylvania United States 15401
    75 Pfizer Investigational Site Wexford Pennsylvania United States 15090
    76 Pfizer Investigational Site Brighton Tennessee United States 38011
    77 Pfizer Investigational Site Memphis Tennessee United States 38104
    78 Pfizer Investigational Site Memphis Tennessee United States 38120
    79 Pfizer Investigational Site Arlington Texas United States 76014
    80 Pfizer Investigational Site Dallas Texas United States 75246
    81 Pfizer Investigational Site Fort Worth Texas United States 76177
    82 Pfizer Investigational Site Houston Texas United States 77030
    83 Pfizer Investigational Site Webster Texas United States 77598
    84 Pfizer Investigational Site Everett Washington United States 98201
    85 Pfizer Investigational Site Monroe Washington United States 98272
    86 Pfizer Investigational Site Seattle Washington United States 98101
    87 Pfizer Investigational Site Milwaukee Wisconsin United States 53226
    88 Pfizer Investigational Site Port Macquarie New South Wales Australia 2444
    89 Pfizer Investigational Site Wahroong New South Wales Australia 2076
    90 Pfizer Investigational Site Westmead New South Wales Australia 2145
    91 Pfizer Investigational Site Wodonga Victoria Australia 3690
    92 Pfizer Investigational Site Bruxelles Belgium 1000
    93 Pfizer Investigational Site Liege Belgium 4000
    94 Pfizer Investigational Site Mons Belgium 7000
    95 Pfizer Investigational Site Namur Belgium 5000
    96 Pfizer Investigational Site Wilrijk Belgium 2610
    97 Pfizer Investigational Site Salvador BA Brazil 40170-110
    98 Pfizer Investigational Site Belo Horizonte MG Brazil 30150-281
    99 Pfizer Investigational Site Rio de Janeiro RJ Brazil 22260-020
    100 Pfizer Investigational Site Caxias do Sul RS Brazil 95070-560
    101 Pfizer Investigational Site Porto Alegre RS Brazil 90050-170
    102 Pfizer Investigational Site Santo André SP Brazil 09060-650
    103 Pfizer Investigational Site Kelowna British Columbia Canada V1Y 5L3
    104 Pfizer Investigational Site Barrie Ontario Canada L4M 6M2
    105 Pfizer Investigational Site Oshawa Ontario Canada L1G 2B9
    106 Pfizer Investigational Site Montreal Quebec Canada H2L 4M1
    107 Pfizer Investigational Site Montreal Quebec Canada H3G 1A4
    108 Pfizer Investigational Site Sherbrooke Quebec Canada J1H 5N4
    109 Pfizer Investigational Site WuHan Hubei China 430030
    110 Pfizer Investigational Site Beijing China 100036
    111 Pfizer Investigational Site Chongqing China 400038
    112 Pfizer Investigational Site Shanghai China 200032
    113 Pfizer Investigational Site Shanghai China 200433
    114 Pfizer Investigational Site Brno Czech Republic 625 00
    115 Pfizer Investigational Site Olomouc Czech Republic 775 20
    116 Pfizer Investigational Site Usti nad Labem Czech Republic 40113
    117 Pfizer Investigational Site Herlev Denmark 2730
    118 Pfizer Investigational Site Koebenhavn Oe Denmark 2100
    119 Pfizer Investigational Site Odense C Denmark 5000
    120 Pfizer Investigational Site Vejle Denmark 7100
    121 Pfizer Investigational Site Helsinki Finland 00290
    122 Pfizer Investigational Site Tampere Finland 33520
    123 Pfizer Investigational Site Besancon France 25030
    124 Pfizer Investigational Site Bordeaux Cedex France 33076
    125 Pfizer Investigational Site Clermont-Ferrand Cedex 1 France 63011
    126 Pfizer Investigational Site Lille France 59000
    127 Pfizer Investigational Site Lyon France 69008
    128 Pfizer Investigational Site Paris Cedex 15 France 75908
    129 Pfizer Investigational Site Poitiers cedex France 86021
    130 Pfizer Investigational Site Rennes France 35042
    131 Pfizer Investigational Site ROUEN Cedex France 76031
    132 Pfizer Investigational Site Saint Gregoire France 35760
    133 Pfizer Investigational Site Tours France 37044
    134 Pfizer Investigational Site Berlin Germany 10719
    135 Pfizer Investigational Site Homburg/Saar Germany 66421
    136 Pfizer Investigational Site Kempen Germany 47906
    137 Pfizer Investigational Site Leipzig Germany 04109
    138 Pfizer Investigational Site Muenchen Germany 81675
    139 Pfizer Investigational Site Muenster Germany 48149
    140 Pfizer Investigational Site Tuebingen Germany 72076
    141 Pfizer Investigational Site Ulm Germany 89081
    142 Pfizer Investigational Site Kfar Saba Israel
    143 Pfizer Investigational Site Petach Tikva Israel 49100
    144 Pfizer Investigational Site Tel Hashomer Israel 52621
    145 Pfizer Investigational Site Zerifin Israel 70300
    146 Pfizer Investigational Site Meldola FC Italy 47014
    147 Pfizer Investigational Site Lido di Camaiore (LU) Italy 55043
    148 Pfizer Investigational Site Napoli Italy 80131
    149 Pfizer Investigational Site Padova Italy 35128
    150 Pfizer Investigational Site Pavia Italy 27100
    151 Pfizer Investigational Site Pisa Italy 56100
    152 Pfizer Investigational Site Potenza Italy 85100
    153 Pfizer Investigational Site Roma Italy 00135
    154 Pfizer Investigational Site Roma Italy 00152
    155 Pfizer Investigational Site Goyang-si Gyeonggi-do Korea, Republic of 410-769
    156 Pfizer Investigational Site Seongnam Gyunggido Korea, Republic of 463-802
    157 Pfizer Investigational Site Seoul Korea, Republic of 120-752
    158 Pfizer Investigational Site Seoul Korea, Republic of 135-710
    159 Pfizer Investigational Site Seoul Korea, Republic of 138-736
    160 Pfizer Investigational Site Bellavista Callao Peru Callao 02
    161 Pfizer Investigational Site Arequipa Peru
    162 Pfizer Investigational Site Lima Peru Lima 27
    163 Pfizer Investigational Site Gdansk Poland 80-952
    164 Pfizer Investigational Site Kielce Poland 25-734
    165 Pfizer Investigational Site Warszawa Poland 02-507
    166 Pfizer Investigational Site Warszawa Poland 02-781
    167 Pfizer Investigational Site Porto Portugal 4200-072
    168 Pfizer Investigational Site Porto Portugal 4200-319
    169 Pfizer Investigational Site Setúbal Portugal 2910-446
    170 Pfizer Investigational Site Bratislava Slovakia 833 10
    171 Pfizer Investigational Site Bratislava Slovakia 85105
    172 Pfizer Investigational Site Martin Slovakia 036 01
    173 Pfizer Investigational Site Prešov Slovakia 080 01
    174 Pfizer Investigational Site Zilina Slovakia 012 07
    175 Pfizer Investigational Site Elche Alicante Spain 03203
    176 Pfizer Investigational Site L'hospitalet de Llobregat Barcelona Spain 08907
    177 Pfizer Investigational Site Pamplona Navarra Spain 31008
    178 Pfizer Investigational Site A Coruña Spain 15006
    179 Pfizer Investigational Site Barcelona Spain 08035
    180 Pfizer Investigational Site Gerona Spain 17007
    181 Pfizer Investigational Site Guadalajara Spain 19002
    182 Pfizer Investigational Site Madrid Spain 28034
    183 Pfizer Investigational Site Madrid Spain 28041
    184 Pfizer Investigational Site Madrid Spain 28050
    185 Pfizer Investigational Site Sevilla Spain 41013
    186 Pfizer Investigational Site Valencia Spain 46026
    187 Pfizer Investigational Site Lund Sweden 221 85
    188 Pfizer Investigational Site Malmo Sweden 205 02
    189 Pfizer Investigational Site Stockholm Sweden 171 76
    190 Pfizer Investigational Site Vaxjo Sweden 351 85
    191 Pfizer Investigational Site Taichung Taiwan 407
    192 Pfizer Investigational Site Taipei Taiwan 100
    193 Pfizer Investigational Site Taipei Taiwan 112
    194 Pfizer Investigational Site Taoyuan Taiwan 333
    195 Pfizer Investigational Site Bournemouth Dorset United Kingdom BH7 7DW
    196 Pfizer Investigational Site Preston Lancashire United Kingdom PR2 9HT
    197 Pfizer Investigational Site Northwood, Middlesex United Kingdom HA6 2RN
    198 Pfizer Investigational Site Bristol United Kingdom BS2 8ED
    199 Pfizer Investigational Site Cardiff United Kingdom CF14 2TL
    200 Pfizer Investigational Site Glasgow United Kingdom G12 0YN
    201 Pfizer Investigational Site Glasgow United Kingdom G52 3NQ
    202 Pfizer Investigational Site Guildford United Kingdom GU2 7XX
    203 Pfizer Investigational Site London United Kingdom SE1 9RT
    204 Pfizer Investigational Site Sheffield United Kingdom S10 2SJ
    205 Pfizer Investigational Site Swansea United Kingdom SA2 8QA

    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:
    NCT00676650
    Other Study ID Numbers:
    • A6181120
    First Posted:
    May 13, 2008
    Last Update Posted:
    Mar 8, 2013
    Last Verified:
    Feb 1, 2013
    Keywords provided by Pfizer
    Docetaxel-refractory mCRPC
    Second-line treatment with sunitinib and prednisone
    Additional relevant MeSH terms:
    Prostatic Neoplasms
    Prednisone
    Sunitinib

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Sunitinib and Prednisone Placebo and Prednisone
    Arm/Group Description Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution. Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
    Period Title: Overall Study
    STARTED 584 289
    Treated 581 285
    COMPLETED 0 0
    NOT COMPLETED 584 289

    Baseline Characteristics

    Arm/Group Title Sunitinib and Prednisone Placebo and Prednisone Total
    Arm/Group Description Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution. Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution. Total of all reporting groups
    Overall Participants 584 289 873
    Age, Customized (participants) [Number]
    18 - 44 years
    3
    0.5%
    0
    0%
    3
    0.3%
    45 - 64 years
    177
    30.3%
    97
    33.6%
    274
    31.4%
    greater than or equal to (>=) 65 years
    404
    69.2%
    192
    66.4%
    596
    68.3%
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    0
    0%
    0
    0%
    Male
    584
    100%
    289
    100%
    873
    100%

    Outcome Measures

    1. Primary Outcome
    Title Overall Survival (OS)
    Description OS is the duration from randomization to death. For participants who were alive, overall survival was censored at the last contact. OS (in months) calculated as (date of death minus [-] date of randomization plus [+] 1) divided (/) 30.4.
    Time Frame Baseline up to 32 months

    Outcome Measure Data

    Analysis Population Description
    Full analysis (FA) population: all participants who were randomized, with study drug assignment designated according to initial randomization, regaradless of whether participant received study drug according to the randomization schedule.
    Arm/Group Title Sunitinib and Prednisone Placebo and Prednisone
    Arm/Group Description Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution. Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
    Measure Participants 584 289
    Median (95% Confidence Interval) [months]
    13.1
    11.8
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sunitinib and Prednisone, Placebo and Prednisone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1678
    Comments 1-sided p-value from the stratified log-rank test
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.914
    Confidence Interval (2-Sided) 95%
    0.762 to 1.097
    Parameter Dispersion Type:
    Value:
    Estimation Comments Based on the Cox Proportional hazards model stratified by Eastern Cooperative Oncology Group (ECOG) and Disease Progression Base.
    2. Secondary Outcome
    Title Progression-Free Survival (PFS)
    Description PFS is the period from randomization until disease progression or death on study. PFS is censored on the date of last tumor assessment documenting absence of progressive disease. PFS (weeks) calculated as (first event date - randomization date + 1)/7.02
    Time Frame Baseline, every 8 weeks up to 123 weeks

    Outcome Measure Data

    Analysis Population Description
    FA Population
    Arm/Group Title Sunitinib and Prednisone Placebo and Prednisone
    Arm/Group Description Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution. Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
    Measure Participants 584 289
    Median (95% Confidence Interval) [weeks]
    24.1
    17.9
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sunitinib and Prednisone, Placebo and Prednisone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments 1-sided p-value from the stratified log-rank test.
    Method Log Rank
    Comments
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.725
    Confidence Interval (2-Sided) 95%
    0.591 to 0.890
    Parameter Dispersion Type:
    Value:
    Estimation Comments Based on Cox Proportional Hazards Model stratified by ECOG and Disease Progression Base.
    3. Secondary Outcome
    Title Percent of Participants With Objective Response (OR)
    Description OR defined as the percent (%) of participants with confirmed Complete Response (CR) (disappearance of all target lesions) or Partial Response (PR) (>=30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to the full analysis population. Confirmed responses were those that persist on repeat imagining study >= 4 weeks after initial documentation of response.
    Time Frame Baseline, every 8 weeks up to 123 weeks

    Outcome Measure Data

    Analysis Population Description
    FA Population
    Arm/Group Title Sunitinib and Prednisone Placebo and Prednisone
    Arm/Group Description Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution. Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
    Measure Participants 584 289
    Number (95% Confidence Interval) [percentage of participants]
    6.1
    1%
    1.8
    0.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Sunitinib and Prednisone, Placebo and Prednisone
    Comments
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.040
    Comments p-value from 2-sided Fisher's Exact test.
    Method Fisher Exact
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.561
    Confidence Interval (2-Sided) 95%
    1.0 to 19.0
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Duration of Response (DR)
    Description Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cause. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cause - the date of the first CR or PR that was subsequently confirmed plus 1 divided by 7.02. DR calculated for the subgroup of participants with a confirmed objective tumor response
    Time Frame Baseline, every 8 weeks up to 123 weeks

    Outcome Measure Data

    Analysis Population Description
    Data not summarized, study terminated early
    Arm/Group Title Sunitinib and Prednisone Placebo and Prednisone
    Arm/Group Description Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution. Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
    Measure Participants 0 0
    5. Secondary Outcome
    Title Change From Baseline in Pain Severity
    Description Pain severity recorded on a numerical scale ranging from 0 (no pain) to 10 (pain as bad as you can imagine). Higher scores indicated greater level of pain. The pain score for each cycle averaged for the 7 days.
    Time Frame Day 1 through Day 7 every 28 days (every cycle) up to 29 months

    Outcome Measure Data

    Analysis Population Description
    Data not summarized, study terminated early
    Arm/Group Title Sunitinib and Prednisone Placebo and Prednisone
    Arm/Group Description Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution. Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
    Measure Participants 0 0
    6. Secondary Outcome
    Title Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P)
    Description FACT-P is a validated, self-administered instrument used to assess health-related quality of life and prostate cancer-specific symptoms. Scores ranged from 0 (not at all) to 4 (very much). It is 27-item FACT-General and 12 items for the prostate cancer specific concerns. The 27 items in FACT-G are grouped into 4 domains: physical well-being, social/family well-being, emotional well-being and functional well-being. The 12 prostate cancer symptoms items focus on pain (3 items), urination problems (3 items), sexual functions (2 items), weight loss, appetite, overall comfort, and bowel movement.
    Time Frame Baseline, every 4 weeks up to 123 weeks

    Outcome Measure Data

    Analysis Population Description
    Data not summarized, study terminated early
    Arm/Group Title Sunitinib and Prednisone Placebo and Prednisone
    Arm/Group Description Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution. Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
    Measure Participants 0 0
    7. Secondary Outcome
    Title Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility Score
    Description EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Overall scores range from 0 to 1, with lower scores representing a higher level of dysfunction.
    Time Frame Baseline, every 4 weeks up to 123 weeks

    Outcome Measure Data

    Analysis Population Description
    Data not summarized, study terminated early
    Arm/Group Title Sunitinib and Prednisone Placebo and Prednisone
    Arm/Group Description Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution. Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
    Measure Participants 0 0

    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 and Prednisone Placebo and Prednisone
    Arm/Group Description Sunitinib capsules administered orally as a continuous daily dose in a continuous regimen, expressed as 4-week cycles; starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3. Prednisone administered continuously at 5 mg orally twice a day (BID) as either a tablet, solution or concentrated solution. Matched placebo administered orally as a continuous daily dose expressed as 4-week cycles; with a starting dose of 37.5 milligrams (mg) with option to increase dose to 50 mg at Cycle 3 plus prednisone administered continuously at 5 mg orally BID as either a tablet, solution or concentrated solution.
    All Cause Mortality
    Sunitinib and Prednisone Placebo and Prednisone
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Sunitinib and Prednisone Placebo and Prednisone
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 275/581 (47.3%) 86/285 (30.2%)
    Blood and lymphatic system disorders
    Anaemia 21/581 (3.6%) 3/285 (1.1%)
    Disseminated intravascular coagulation 1/581 (0.2%) 1/285 (0.4%)
    Febrile bone marrow aplasia 1/581 (0.2%) 0/285 (0%)
    Febrile neutropenia 2/581 (0.3%) 0/285 (0%)
    Leukopenia 3/581 (0.5%) 0/285 (0%)
    Neutropenia 1/581 (0.2%) 0/285 (0%)
    Pancytopenia 3/581 (0.5%) 0/285 (0%)
    Thrombocytopenia 8/581 (1.4%) 1/285 (0.4%)
    Thrombotic thrombocytopenic purpura 1/581 (0.2%) 0/285 (0%)
    Cardiac disorders
    Acute coronary syndrome 1/581 (0.2%) 0/285 (0%)
    Acute myocardial infarction 3/581 (0.5%) 0/285 (0%)
    Atrial flutter 1/581 (0.2%) 0/285 (0%)
    Atrioventricular block second degree 1/581 (0.2%) 0/285 (0%)
    Cardiac failure 2/581 (0.3%) 0/285 (0%)
    Cardiac failure congestive 1/581 (0.2%) 0/285 (0%)
    Cardio-respiratory arrest 2/581 (0.3%) 1/285 (0.4%)
    Cardiogenic shock 1/581 (0.2%) 0/285 (0%)
    Left ventricular dysfunction 1/581 (0.2%) 0/285 (0%)
    Myocardial infarction 1/581 (0.2%) 1/285 (0.4%)
    Myocardial ischaemia 0/581 (0%) 1/285 (0.4%)
    Congenital, familial and genetic disorders
    Cerebral arteriovenous malformation haemorrhagic 1/581 (0.2%) 0/285 (0%)
    Ear and labyrinth disorders
    Vertigo 1/581 (0.2%) 0/285 (0%)
    Vestibular disorder 1/581 (0.2%) 0/285 (0%)
    Endocrine disorders
    Adrenal insufficiency 0/581 (0%) 1/285 (0.4%)
    Inappropriate antidiuretic hormone secretion 0/581 (0%) 1/285 (0.4%)
    Eye disorders
    Conjunctival oedema 1/581 (0.2%) 0/285 (0%)
    Diplopia 1/581 (0.2%) 0/285 (0%)
    Optic ischaemic neuropathy 1/581 (0.2%) 0/285 (0%)
    Gastrointestinal disorders
    Abdominal pain 3/581 (0.5%) 1/285 (0.4%)
    Abdominal pain upper 2/581 (0.3%) 0/285 (0%)
    Anal fistula 2/581 (0.3%) 0/285 (0%)
    Anal haemorrhage 1/581 (0.2%) 0/285 (0%)
    Anal ulcer 1/581 (0.2%) 0/285 (0%)
    Colitis 1/581 (0.2%) 0/285 (0%)
    Constipation 3/581 (0.5%) 3/285 (1.1%)
    Diarrhoea 7/581 (1.2%) 1/285 (0.4%)
    Diverticular perforation 1/581 (0.2%) 0/285 (0%)
    Duodenitis 1/581 (0.2%) 0/285 (0%)
    Gastric ulcer 4/581 (0.7%) 0/285 (0%)
    Gastrointestinal haemorrhage 7/581 (1.2%) 1/285 (0.4%)
    Gingival bleeding 2/581 (0.3%) 0/285 (0%)
    Haematemesis 1/581 (0.2%) 0/285 (0%)
    Haematochezia 1/581 (0.2%) 0/285 (0%)
    Haemorrhoidal haemorrhage 1/581 (0.2%) 0/285 (0%)
    Intestinal haemorrhage 1/581 (0.2%) 0/285 (0%)
    Intestinal ischaemia 1/581 (0.2%) 0/285 (0%)
    Intestinal obstruction 2/581 (0.3%) 0/285 (0%)
    Large intestine perforation 2/581 (0.3%) 0/285 (0%)
    Lower gastrointestinal haemorrhage 1/581 (0.2%) 0/285 (0%)
    Melaena 3/581 (0.5%) 0/285 (0%)
    Mouth haemorrhage 1/581 (0.2%) 0/285 (0%)
    Nausea 13/581 (2.2%) 4/285 (1.4%)
    Oesophagitis 3/581 (0.5%) 0/285 (0%)
    Pancreatitis acute 1/581 (0.2%) 0/285 (0%)
    Peptic ulcer 1/581 (0.2%) 0/285 (0%)
    Proctitis 1/581 (0.2%) 0/285 (0%)
    Rectal haemorrhage 2/581 (0.3%) 1/285 (0.4%)
    Rectal ulcer 2/581 (0.3%) 0/285 (0%)
    Rectal ulcer haemorrhage 1/581 (0.2%) 0/285 (0%)
    Rectourethral fistula 1/581 (0.2%) 0/285 (0%)
    Small intestinal obstruction 1/581 (0.2%) 0/285 (0%)
    Stomatitis 1/581 (0.2%) 0/285 (0%)
    Vomiting 16/581 (2.8%) 5/285 (1.8%)
    General disorders
    Asthenia 14/581 (2.4%) 1/285 (0.4%)
    Chest pain 3/581 (0.5%) 2/285 (0.7%)
    Death 5/581 (0.9%) 1/285 (0.4%)
    Device occlusion 2/581 (0.3%) 1/285 (0.4%)
    Disease progression 32/581 (5.5%) 19/285 (6.7%)
    Fatigue 2/581 (0.3%) 1/285 (0.4%)
    General physical health deterioration 10/581 (1.7%) 2/285 (0.7%)
    Ill-defined disorder 2/581 (0.3%) 0/285 (0%)
    Impaired healing 1/581 (0.2%) 0/285 (0%)
    Influenza like illness 1/581 (0.2%) 0/285 (0%)
    Malaise 2/581 (0.3%) 0/285 (0%)
    Medical device complication 1/581 (0.2%) 0/285 (0%)
    Mucosal inflammation 1/581 (0.2%) 0/285 (0%)
    Multi-organ failure 1/581 (0.2%) 0/285 (0%)
    Oedema peripheral 2/581 (0.3%) 0/285 (0%)
    Pain 2/581 (0.3%) 4/285 (1.4%)
    Performance status decreased 2/581 (0.3%) 0/285 (0%)
    Pyrexia 11/581 (1.9%) 3/285 (1.1%)
    Sudden cardiac death 1/581 (0.2%) 0/285 (0%)
    Sudden death 0/581 (0%) 1/285 (0.4%)
    Hepatobiliary disorders
    Cholecystitis acute 4/581 (0.7%) 0/285 (0%)
    Cholelithiasis 0/581 (0%) 1/285 (0.4%)
    Gallbladder disorder 1/581 (0.2%) 0/285 (0%)
    Hepatic failure 1/581 (0.2%) 1/285 (0.4%)
    Hepatitis cholestatic 1/581 (0.2%) 0/285 (0%)
    Hepatorenal failure 0/581 (0%) 1/285 (0.4%)
    Hepatotoxicity 1/581 (0.2%) 0/285 (0%)
    Infections and infestations
    Anal abscess 6/581 (1%) 0/285 (0%)
    Appendicitis 1/581 (0.2%) 0/285 (0%)
    Bronchitis 1/581 (0.2%) 0/285 (0%)
    Cellulitis 1/581 (0.2%) 0/285 (0%)
    Cholecystitis infective 1/581 (0.2%) 0/285 (0%)
    Clostridial infection 1/581 (0.2%) 0/285 (0%)
    Device related infection 1/581 (0.2%) 0/285 (0%)
    Diverticulitis 4/581 (0.7%) 0/285 (0%)
    Febrile infection 0/581 (0%) 1/285 (0.4%)
    Gastroenteritis 2/581 (0.3%) 0/285 (0%)
    Herpes zoster 1/581 (0.2%) 1/285 (0.4%)
    Infection 4/581 (0.7%) 0/285 (0%)
    Infectious peritonitis 1/581 (0.2%) 0/285 (0%)
    Lower respiratory tract infection 1/581 (0.2%) 0/285 (0%)
    Meningitis bacterial 0/581 (0%) 1/285 (0.4%)
    Oral fungal infection 1/581 (0.2%) 0/285 (0%)
    Otitis media chronic 1/581 (0.2%) 0/285 (0%)
    Paronychia 0/581 (0%) 1/285 (0.4%)
    Perirectal abscess 1/581 (0.2%) 0/285 (0%)
    Pneumonia 4/581 (0.7%) 4/285 (1.4%)
    Pseudomonas infection 1/581 (0.2%) 0/285 (0%)
    Pyelonephritis 1/581 (0.2%) 0/285 (0%)
    Rectal abscess 1/581 (0.2%) 0/285 (0%)
    Sepsis 3/581 (0.5%) 0/285 (0%)
    Septic shock 2/581 (0.3%) 0/285 (0%)
    Staphylococcal bacteraemia 0/581 (0%) 1/285 (0.4%)
    Subcutaneous abscess 1/581 (0.2%) 0/285 (0%)
    Tooth infection 1/581 (0.2%) 0/285 (0%)
    Upper respiratory tract infection 1/581 (0.2%) 0/285 (0%)
    Urinary tract infection 10/581 (1.7%) 7/285 (2.5%)
    Urinary tract infection bacterial 0/581 (0%) 1/285 (0.4%)
    Urosepsis 1/581 (0.2%) 1/285 (0.4%)
    Injury, poisoning and procedural complications
    Compression fracture 0/581 (0%) 1/285 (0.4%)
    Cystitis radiation 2/581 (0.3%) 0/285 (0%)
    Fall 5/581 (0.9%) 1/285 (0.4%)
    Fracture 1/581 (0.2%) 0/285 (0%)
    Hand fracture 0/581 (0%) 1/285 (0.4%)
    Head injury 2/581 (0.3%) 0/285 (0%)
    Hip fracture 1/581 (0.2%) 0/285 (0%)
    Humerus fracture 1/581 (0.2%) 0/285 (0%)
    Jaw fracture 1/581 (0.2%) 0/285 (0%)
    Laceration 0/581 (0%) 1/285 (0.4%)
    Procedural complication 1/581 (0.2%) 0/285 (0%)
    Subdural haemorrhage 0/581 (0%) 1/285 (0.4%)
    Toxicity to various agents 2/581 (0.3%) 0/285 (0%)
    Investigations
    Aspartate aminotransferase increased 1/581 (0.2%) 0/285 (0%)
    Blood alkaline phosphatase increased 1/581 (0.2%) 0/285 (0%)
    Blood creatine phosphokinase increased 1/581 (0.2%) 0/285 (0%)
    Blood creatinine increased 2/581 (0.3%) 0/285 (0%)
    Blood urea increased 2/581 (0.3%) 0/285 (0%)
    C-reactive protein increased 0/581 (0%) 1/285 (0.4%)
    Eastern Cooperative Oncology Group performance status worsened 1/581 (0.2%) 0/285 (0%)
    Haemoglobin decreased 2/581 (0.3%) 0/285 (0%)
    Prothrombin time prolonged 1/581 (0.2%) 0/285 (0%)
    Urine output decreased 1/581 (0.2%) 0/285 (0%)
    Metabolism and nutrition disorders
    Decreased appetite 6/581 (1%) 2/285 (0.7%)
    Dehydration 17/581 (2.9%) 2/285 (0.7%)
    Diabetes mellitus 1/581 (0.2%) 0/285 (0%)
    Diabetic ketoacidosis 0/581 (0%) 1/285 (0.4%)
    Failure to thrive 2/581 (0.3%) 0/285 (0%)
    Hyperkalaemia 1/581 (0.2%) 0/285 (0%)
    Hypocalcaemia 1/581 (0.2%) 0/285 (0%)
    Hypoglycaemia 4/581 (0.7%) 0/285 (0%)
    Hypokalaemia 2/581 (0.3%) 0/285 (0%)
    Hypomagnesaemia 1/581 (0.2%) 0/285 (0%)
    Hyponatraemia 2/581 (0.3%) 2/285 (0.7%)
    Hypophosphataemia 1/581 (0.2%) 0/285 (0%)
    Hypovolaemia 1/581 (0.2%) 0/285 (0%)
    Malnutrition 1/581 (0.2%) 0/285 (0%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 2/581 (0.3%) 1/285 (0.4%)
    Back pain 2/581 (0.3%) 3/285 (1.1%)
    Bone pain 10/581 (1.7%) 5/285 (1.8%)
    Bursitis 1/581 (0.2%) 0/285 (0%)
    Muscle haemorrhage 1/581 (0.2%) 0/285 (0%)
    Muscular weakness 1/581 (0.2%) 1/285 (0.4%)
    Musculoskeletal pain 2/581 (0.3%) 0/285 (0%)
    Osteitis 1/581 (0.2%) 1/285 (0.4%)
    Osteonecrosis 2/581 (0.3%) 0/285 (0%)
    Osteonecrosis of jaw 2/581 (0.3%) 0/285 (0%)
    Pain in extremity 2/581 (0.3%) 0/285 (0%)
    Polymyalgia rheumatica 0/581 (0%) 1/285 (0.4%)
    Spinal column stenosis 0/581 (0%) 1/285 (0.4%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Bladder cancer 0/581 (0%) 1/285 (0.4%)
    Cancer pain 1/581 (0.2%) 0/285 (0%)
    Malignant pleural effusion 0/581 (0%) 1/285 (0.4%)
    Pancreatic carcinoma 1/581 (0.2%) 0/285 (0%)
    Prostate cancer 2/581 (0.3%) 0/285 (0%)
    Prostate cancer metastatic 1/581 (0.2%) 1/285 (0.4%)
    Rectal cancer 1/581 (0.2%) 0/285 (0%)
    Transitional cell carcinoma 1/581 (0.2%) 0/285 (0%)
    Tumour pain 1/581 (0.2%) 0/285 (0%)
    Nervous system disorders
    Aphasia 0/581 (0%) 1/285 (0.4%)
    Cerebral ischaemia 1/581 (0.2%) 0/285 (0%)
    Cerebrovascular accident 3/581 (0.5%) 0/285 (0%)
    Convulsion 2/581 (0.3%) 0/285 (0%)
    Depressed level of consciousness 1/581 (0.2%) 0/285 (0%)
    Dizziness 3/581 (0.5%) 0/285 (0%)
    Facial paresis 0/581 (0%) 1/285 (0.4%)
    Haemorrhage intracranial 2/581 (0.3%) 0/285 (0%)
    Headache 1/581 (0.2%) 0/285 (0%)
    Hydrocephalus 0/581 (0%) 1/285 (0.4%)
    Ischaemic stroke 2/581 (0.3%) 0/285 (0%)
    Nervous system disorder 1/581 (0.2%) 0/285 (0%)
    Paraesthesia 2/581 (0.3%) 0/285 (0%)
    Partial seizures 0/581 (0%) 1/285 (0.4%)
    Peripheral motor neuropathy 1/581 (0.2%) 0/285 (0%)
    Peripheral sensory neuropathy 0/581 (0%) 1/285 (0.4%)
    Polyneuropathy in malignant disease 0/581 (0%) 1/285 (0.4%)
    Post herpetic neuralgia 0/581 (0%) 1/285 (0.4%)
    Spinal cord compression 3/581 (0.5%) 3/285 (1.1%)
    Subarachnoid haemorrhage 1/581 (0.2%) 0/285 (0%)
    Syncope 3/581 (0.5%) 0/285 (0%)
    Transient ischaemic attack 2/581 (0.3%) 0/285 (0%)
    VIIth nerve paralysis 1/581 (0.2%) 0/285 (0%)
    Psychiatric disorders
    Confusional state 3/581 (0.5%) 3/285 (1.1%)
    Hallucination 1/581 (0.2%) 0/285 (0%)
    Mental disorder due to a general medical condition 2/581 (0.3%) 0/285 (0%)
    Renal and urinary disorders
    Azotaemia 1/581 (0.2%) 0/285 (0%)
    Bladder obstruction 1/581 (0.2%) 0/285 (0%)
    Bladder tamponade 1/581 (0.2%) 0/285 (0%)
    Dysuria 1/581 (0.2%) 1/285 (0.4%)
    Haematuria 13/581 (2.2%) 3/285 (1.1%)
    Hydronephrosis 1/581 (0.2%) 2/285 (0.7%)
    Nephrolithiasis 1/581 (0.2%) 0/285 (0%)
    Nephrotic syndrome 1/581 (0.2%) 0/285 (0%)
    Obstructive uropathy 1/581 (0.2%) 1/285 (0.4%)
    Renal failure 1/581 (0.2%) 1/285 (0.4%)
    Renal failure acute 8/581 (1.4%) 2/285 (0.7%)
    Renal impairment 1/581 (0.2%) 0/285 (0%)
    Ureteric obstruction 2/581 (0.3%) 0/285 (0%)
    Urethral haemorrhage 1/581 (0.2%) 0/285 (0%)
    Urinary bladder haemorrhage 3/581 (0.5%) 0/285 (0%)
    Urinary retention 3/581 (0.5%) 3/285 (1.1%)
    Urinary tract obstruction 1/581 (0.2%) 1/285 (0.4%)
    Reproductive system and breast disorders
    Pelvic pain 1/581 (0.2%) 0/285 (0%)
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease 0/581 (0%) 1/285 (0.4%)
    Dyspnoea 8/581 (1.4%) 0/285 (0%)
    Epistaxis 4/581 (0.7%) 0/285 (0%)
    Haemoptysis 1/581 (0.2%) 0/285 (0%)
    Hydropneumothorax 1/581 (0.2%) 0/285 (0%)
    Hypoxia 1/581 (0.2%) 0/285 (0%)
    Lung infiltration 1/581 (0.2%) 0/285 (0%)
    Pleural effusion 2/581 (0.3%) 1/285 (0.4%)
    Pneumonia aspiration 1/581 (0.2%) 0/285 (0%)
    Pneumonitis 1/581 (0.2%) 0/285 (0%)
    Pulmonary embolism 19/581 (3.3%) 3/285 (1.1%)
    Respiratory arrest 1/581 (0.2%) 0/285 (0%)
    Skin and subcutaneous tissue disorders
    Skin hyperpigmentation 1/581 (0.2%) 0/285 (0%)
    Surgical and medical procedures
    Pain management 1/581 (0.2%) 0/285 (0%)
    Vascular disorders
    Circulatory collapse 1/581 (0.2%) 0/285 (0%)
    Deep vein thrombosis 4/581 (0.7%) 1/285 (0.4%)
    Haematoma 1/581 (0.2%) 0/285 (0%)
    Haemorrhage 1/581 (0.2%) 0/285 (0%)
    Hypertension 4/581 (0.7%) 0/285 (0%)
    Hypotension 0/581 (0%) 1/285 (0.4%)
    Peripheral vascular disorder 1/581 (0.2%) 0/285 (0%)
    Phlebitis 0/581 (0%) 1/285 (0.4%)
    Venous thrombosis limb 1/581 (0.2%) 0/285 (0%)
    Other (Not Including Serious) Adverse Events
    Sunitinib and Prednisone Placebo and Prednisone
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 573/581 (98.6%) 256/285 (89.8%)
    Blood and lymphatic system disorders
    Anaemia 140/581 (24.1%) 53/285 (18.6%)
    Leukopenia 60/581 (10.3%) 2/285 (0.7%)
    Neutropenia 84/581 (14.5%) 1/285 (0.4%)
    Thrombocytopenia 72/581 (12.4%) 8/285 (2.8%)
    Gastrointestinal disorders
    Abdominal pain 41/581 (7.1%) 13/285 (4.6%)
    Abdominal pain upper 39/581 (6.7%) 10/285 (3.5%)
    Constipation 112/581 (19.3%) 56/285 (19.6%)
    Diarrhoea 267/581 (46%) 43/285 (15.1%)
    Dry mouth 41/581 (7.1%) 13/285 (4.6%)
    Dyspepsia 99/581 (17%) 11/285 (3.9%)
    Nausea 240/581 (41.3%) 68/285 (23.9%)
    Stomatitis 81/581 (13.9%) 11/285 (3.9%)
    Vomiting 189/581 (32.5%) 39/285 (13.7%)
    General disorders
    Asthenia 153/581 (26.3%) 41/285 (14.4%)
    Fatigue 202/581 (34.8%) 69/285 (24.2%)
    Mucosal inflammation 118/581 (20.3%) 14/285 (4.9%)
    Oedema peripheral 63/581 (10.8%) 23/285 (8.1%)
    Pain 49/581 (8.4%) 24/285 (8.4%)
    Pyrexia 57/581 (9.8%) 12/285 (4.2%)
    Infections and infestations
    Urinary tract infection 51/581 (8.8%) 12/285 (4.2%)
    Investigations
    Aspartate aminotransferase increased 29/581 (5%) 6/285 (2.1%)
    Blood alkaline phosphatase increased 37/581 (6.4%) 17/285 (6%)
    Haemoglobin decreased 36/581 (6.2%) 6/285 (2.1%)
    Weight decreased 115/581 (19.8%) 25/285 (8.8%)
    Metabolism and nutrition disorders
    Decreased appetite 237/581 (40.8%) 52/285 (18.2%)
    Dehydration 32/581 (5.5%) 5/285 (1.8%)
    Hypokalaemia 35/581 (6%) 8/285 (2.8%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 56/581 (9.6%) 26/285 (9.1%)
    Back pain 87/581 (15%) 58/285 (20.4%)
    Bone pain 62/581 (10.7%) 45/285 (15.8%)
    Muscle spasms 21/581 (3.6%) 16/285 (5.6%)
    Muscular weakness 32/581 (5.5%) 13/285 (4.6%)
    Musculoskeletal pain 37/581 (6.4%) 14/285 (4.9%)
    Pain in extremity 75/581 (12.9%) 38/285 (13.3%)
    Nervous system disorders
    Dizziness 49/581 (8.4%) 16/285 (5.6%)
    Dysgeusia 170/581 (29.3%) 27/285 (9.5%)
    Headache 50/581 (8.6%) 17/285 (6%)
    Psychiatric disorders
    Insomnia 40/581 (6.9%) 19/285 (6.7%)
    Renal and urinary disorders
    Haematuria 46/581 (7.9%) 15/285 (5.3%)
    Respiratory, thoracic and mediastinal disorders
    Cough 46/581 (7.9%) 12/285 (4.2%)
    Dyspnoea 71/581 (12.2%) 18/285 (6.3%)
    Epistaxis 57/581 (9.8%) 3/285 (1.1%)
    Skin and subcutaneous tissue disorders
    Dry skin 60/581 (10.3%) 18/285 (6.3%)
    Palmar-plantar erythrodysaesthesia syndrome 172/581 (29.6%) 8/285 (2.8%)
    Petechiae 41/581 (7.1%) 4/285 (1.4%)
    Rash 51/581 (8.8%) 17/285 (6%)
    Skin discolouration 33/581 (5.7%) 4/285 (1.4%)
    Yellow skin 78/581 (13.4%) 6/285 (2.1%)
    Vascular disorders
    Hypertension 150/581 (25.8%) 17/285 (6%)

    Limitations/Caveats

    A complete analysis was not performed due to the sponsors early termination of the clinical trial.

    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:
    NCT00676650
    Other Study ID Numbers:
    • A6181120
    First Posted:
    May 13, 2008
    Last Update Posted:
    Mar 8, 2013
    Last Verified:
    Feb 1, 2013