Treatment Use Study With Sunitinib (SU011248) For Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

Sponsor
Pfizer (Industry)
Overall Status
Approved for marketing
CT.gov ID
NCT00130897
Collaborator
(none)
274
76

Study Details

Study Description

Brief Summary

The primary objective of this protocol is to provide access to SU011248 treatment for patients with metastatic RCC who are ineligible for participation in ongoing SU011248 clinical studies and have the potential to derive clinical benefit from treatment with SU011248 based on the judgment of the investigator.

Condition or Disease Intervention/Treatment Phase

Detailed Description

Given that an Expanded Access study does not meet the definition of a controlled clinical investigation, and as such, is not considered an applicable drug clinical trial per NIH, Basic Results for such studies are not required to be reported. Protocol A6181037 has been identified as an Expanded Access trial, and has been registered to ClinicalTrials.gov, however Basic Results will not be posted.

Study Design

Study Type:
Expanded Access
Official Title:
A SU011248 Expanded Access Protocol For Systemic Therapy Of Patients With Metastatic Renal Cell Carcinoma Who Are Ineligible For Participation In Other SU011248 Protocols But May Derive Benefit From Treatment With SU011248
Study Start Date :
Jul 1, 2005
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Nov 1, 2011

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • renal cell carcinoma that is not amendable to standard therapy with curative intent
    Exclusion Criteria:
    • current treatment in another therapeutic clinical trial

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Scottsdale Arizona United States 85260
    2 Pfizer Investigational Site San Francisco California United States 94115-2378
    3 Pfizer Investigational Site San Francisco California United States 94115
    4 Pfizer Investigational Site Aurora Colorado United States 80040-0510
    5 Pfizer Investigational Site Norwalk Connecticut United States 06856
    6 Pfizer Investigational Site Miami Florida United States 33176
    7 Pfizer Investigational Site Ocala Florida United States 34474
    8 Pfizer Investigational Site Tampa Florida United States 33612
    9 Pfizer Investigational Site Atlanta Georgia United States 30309
    10 Pfizer Investigational Site Maywood Illinois United States 60153
    11 Pfizer Investigational Site Indianapolis Indiana United States 46260-2082
    12 Pfizer Investigational Site Council Bluffs Iowa United States 51503
    13 Pfizer Investigational Site Covington Louisiana United States 70433
    14 Pfizer Investigational Site Gretna Louisiana United States 70056
    15 Pfizer Investigational Site Marrero Louisiana United States 70072
    16 Pfizer Investigational Site Metairie Louisiana United States 70002
    17 Pfizer Investigational Site Metairie Louisiana United States 70006
    18 Pfizer Investigational Site New Orleans Louisiana United States 70115
    19 Pfizer Investigational Site Baltimore Maryland United States 21287
    20 Pfizer Investigational Site Boston Massachusetts United States 02114
    21 Pfizer Investigational Site Boston Massachusetts United States 02115
    22 Pfizer Investigational Site Boston Massachusetts United States 02215
    23 Pfizer Investigational Site Detroit Michigan United States 48201
    24 Pfizer Investigational Site Minneapolis Minnesota United States 55455
    25 Pfizer Investigational Site Southaven Mississippi United States 38671
    26 Pfizer Investigational Site Tupelo Mississippi United States 38801
    27 Pfizer Investigational Site Columbia Missouri United States 65201
    28 Pfizer Investigational Site Columbia Missouri United States 65203
    29 Pfizer Investigational Site Omaha Nebraska United States 68198-7680
    30 Pfizer Investigational Site Bronx New York United States 10466
    31 Pfizer Investigational Site New York New York United States 10021
    32 Pfizer Investigational Site New York New York United States 10022
    33 Pfizer Investigational Site Durham North Carolina United States 27710
    34 Pfizer Investigational Site Cleveland Ohio United States 44195
    35 Pfizer Investigational Site Norman Oklahoma United States 73071
    36 Pfizer Investigational Site Oklahoma City Oklahoma United States 73102
    37 Pfizer Investigational Site Oklahoma City Oklahoma United States 73109
    38 Pfizer Investigational Site Oklahoma City Oklahoma United States 73112
    39 Pfizer Investigational Site Oklahoma City Oklahoma United States 73120
    40 Pfizer Investigational Site Tulsa Oklahoma United States 74104
    41 Pfizer Investigational Site Tulsa Oklahoma United States 74136-1902
    42 Pfizer Investigational Site Portland Oregon United States 97210
    43 Pfizer Investigational Site Portland Oregon United States 97227
    44 Pfizer Investigational Site Hershey Pennsylvania United States 17033-0850
    45 Pfizer Investigational Site Memphis Tennessee United States 38104
    46 Pfizer Investigational Site Memphis Tennessee United States 38120
    47 Pfizer Investigational Site Dallas Texas United States 75246
    48 Pfizer Investigational Site Salt Lake City Utah United States 84112
    49 Pfizer Investigational Site Seattle Washington United States 98104
    50 Pfizer Investigational Site Seattle Washington United States 98109
    51 Pfizer Investigational Site Seattle Washington United States 98122
    52 Pfizer Investigational Site Seattle Washington United States 98124
    53 Pfizer Investigational Site Madison Wisconsin United States 53792
    54 Pfizer Investigational Site Buenos Aires Argentina C1034ACO
    55 Pfizer Investigational Site Buenos Aires Argentina C1426ANZ
    56 Pfizer Investigational Site Buenos Aires Argentina C1431FWO
    57 Pfizer Investigational Site Randwick New South Wales Australia 2031
    58 Pfizer Investigational Site St Leonards New South Wales Australia 2065
    59 Pfizer Investigational Site Westmead New South Wales Australia 2145
    60 Pfizer Investigational Site South Brisbane Queensland Australia 4101
    61 Pfizer Investigational Site Elizabeth Vale South Australia Australia 5112
    62 Pfizer Investigational Site Woodville South South Australia Australia 5011
    63 Pfizer Investigational Site East Melbourne Victoria Australia 3002
    64 Pfizer Investigational Site Heidelburg Victoria Australia 3084
    65 Pfizer Investigational Site Perth Western Australia Australia 6000
    66 Pfizer Investigational Site Innsbruck Austria 6020
    67 Pfizer Investigational Site Wien Austria 1090
    68 Pfizer Investigational Site Bruxelles Belgium 1000
    69 Pfizer Investigational Site Bruxelles Belgium 1200
    70 Pfizer Investigational Site Gent Belgium 9000
    71 Pfizer Investigational Site Leuven Belgium 3000
    72 Pfizer Investigational Site Liege Belgium 4000
    73 Pfizer Investigational Site Wilrijk Belgium 2610
    74 Pfizer Investigational Site Sarajevo Bosnia and Herzegovina 71000
    75 Pfizer Investigational Site Salvador BA Brazil 41950-640
    76 Pfizer Investigational Site Belo Horizonte MG Brazil 30380-490
    77 Pfizer Investigational Site Porto Alegre Rio Grande do Sul Brazil 90020-090
    78 Pfizer Investigational Site Rio de Janeiro RJ Brazil 20230-130
    79 Pfizer Investigational Site Rio de Janeiro RJ Brazil 20231-050
    80 Pfizer Investigational Site Porto Alegre RS Brazil 90610-000
    81 Pfizer Investigational Site Jau SP Brazil 17210-120
    82 Pfizer Investigational Site Jaú SP Brazil 17210-080
    83 Pfizer Investigational Site Jaú SP Brazil 17210-120
    84 Pfizer Investigational Site São Paulo SP Brazil 01308-050
    85 Pfizer Investigational Site São Paulo SP Brazil 01509-900
    86 Pfizer Investigational Site São Paulo SP Brazil 05651-000
    87 Pfizer Investigational Site Sofia Bulgaria 1504
    88 Pfizer Investigational Site Sofia Bulgaria 1756
    89 Pfizer Investigational Site Calgary Alberta Canada T2N 4N2
    90 Pfizer Investigational Site Edmonton Alberta Canada T6G 1Z2
    91 Pfizer Investigational Site Kelowna British Columbia Canada V1Y 5L3
    92 Pfizer Investigational Site Vancouver British Columbia Canada V5Z 4E6
    93 Pfizer Investigational Site Victoria British Columbia Canada V8R 6V5
    94 Pfizer Investigational Site Winnipeg Manitoba Canada R3E 0V9
    95 Pfizer Investigational Site Winnnipeg Manitoba Canada R2H 2A6
    96 Pfizer Investigational Site St. John's Newfoundland and Labrador Canada A1B 3V6
    97 Pfizer Investigational Site Halifax Nova Scotia Canada B3H 1V7
    98 Pfizer Investigational Site Halifax Nova Scotia Canada B3H 2Y9
    99 Pfizer Investigational Site London Ontario Canada N6A 4L6
    100 Pfizer Investigational Site Toronto Ontario Canada M4N 3M5
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    102 Pfizer Investigational Site Montreal Quebec Canada H2L 4M1
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    104 Pfizer Investigational Site Quebec Canada G1R 2J6
    105 Pfizer Investigational Site Santiago RM Chile
    106 Pfizer Investigational Site Bogotá Cundinamarca Colombia 0000
    107 Pfizer Investigational Site Cali Colombia
    108 Pfizer Investigational Site Rijeka Croatia 51000
    109 Pfizer Investigational Site Split Croatia 21000
    110 Pfizer Investigational Site Brno Czech Republic 656 53
    111 Pfizer Investigational Site Hradec Kralove Czech Republic 500 05
    112 Pfizer Investigational Site Praha 5 Czech Republic 150 06
    113 Pfizer Investigational Site Praha 8 Czech Republic 180 00
    114 Pfizer Investigational Site Guayaquil Guayas Ecuador
    115 Pfizer Investigational Site Quito Pichincha Ecuador
    116 Pfizer Investigational Site Cairo Egypt
    117 Pfizer Investigational Site Giza Egypt
    118 Pfizer Investigational Site Turku Finland 20521
    119 Pfizer Investigational Site Lyon Cedex 08 France 69008
    120 Pfizer Investigational Site Saint Herblain Cedex France 44805
    121 Pfizer Investigational Site Strasbourg Cedex France 67091
    122 Pfizer Investigational Site Bordeaux France 33000
    123 Pfizer Investigational Site Clermont Ferand France 63011
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    126 Pfizer Investigational Site Montpellier France 34298 cedex 05
    127 Pfizer Investigational Site Paris Cedex 13 France 75651
    128 Pfizer Investigational Site Paris France 75908
    129 Pfizer Investigational Site Reims France 51100
    130 Pfizer Investigational Site Rennes France 35042
    131 Pfizer Investigational Site Tours France 37044
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    133 Pfizer Investigational Site Aachen Germany 52074
    134 Pfizer Investigational Site Berlin Germany 10117
    135 Pfizer Investigational Site Dresden Germany 01307
    136 Pfizer Investigational Site Essen Germany 45122
    137 Pfizer Investigational Site Frankfurt Germany 60590
    138 Pfizer Investigational Site Freiburg Germany 79106
    139 Pfizer Investigational Site Hamburg Germany 20246
    140 Pfizer Investigational Site Hannover Germany 30625
    141 Pfizer Investigational Site Homburg/Saar Germany 66421
    142 Pfizer Investigational Site Jena Germany 07740
    143 Pfizer Investigational Site Kassel Germany 34125
    144 Pfizer Investigational Site Muenchen Germany 81664
    145 Pfizer Investigational Site Nuernberg Germany 90419
    146 Pfizer Investigational Site Rostock Germany 18057
    147 Pfizer Investigational Site Ulm Germany 89081
    148 Pfizer Investigational Site Athens Attiki Greece 115 22
    149 Pfizer Investigational Site Athens Greece 11528
    150 Pfizer Investigational Site Patras Greece 26500
    151 Pfizer Investigational Site Thessaloniki Greece 540 07
    152 Pfizer Investigational Site Hong Hong Hong Kong
    153 Pfizer Investigational Site Budapest Hungary 1122
    154 Pfizer Investigational Site New Delhi Delhi India 110 029
    155 Pfizer Investigational Site Pune Maharashtra India 411 004
    156 Pfizer Investigational Site Parel Mumbai India 400 012
    157 Pfizer Investigational Site Jaipur Rajasthan India 302 004
    158 Pfizer Investigational Site New Delhi India 110 085
    159 Pfizer Investigational Site Dublin 24 Ireland
    160 Pfizer Investigational Site Dublin Ireland
    161 Pfizer Investigational Site Jerusalem Israel
    162 Pfizer Investigational Site Tel Hashomer Israel 52621
    163 Pfizer Investigational Site Bergamo Italy 24128
    164 Pfizer Investigational Site Brescia Italy 25123
    165 Pfizer Investigational Site Cattolica (RN) Italy 47841
    166 Pfizer Investigational Site Cuneo Italy 12100
    167 Pfizer Investigational Site Legnago, VR Italy 37045
    168 Pfizer Investigational Site Modena Italy 41100
    169 Pfizer Investigational Site Napoli Italy 80131
    170 Pfizer Investigational Site Padova Italy 35128
    171 Pfizer Investigational Site Parma Italy 43100
    172 Pfizer Investigational Site Pavia Italy 27100
    173 Pfizer Investigational Site Perugia Italy 06132
    174 Pfizer Investigational Site Pordenone Italy 33170
    175 Pfizer Investigational Site Rimini Italy 47900
    176 Pfizer Investigational Site Roma Italy 00135
    177 Pfizer Investigational Site Roma Italy 00144
    178 Pfizer Investigational Site Roma Italy 00152
    179 Pfizer Investigational Site Torino Italy 10126
    180 Pfizer Investigational Site Seoul Korea, Republic of 110-744
    181 Pfizer Investigational Site Seoul Korea, Republic of 120-753
    182 Pfizer Investigational Site Beirut Lebanon
    183 Pfizer Investigational Site Petaling Jaya Selangor Malaysia 46050
    184 Pfizer Investigational Site Kuala Lumpur Malaysia 59100
    185 Pfizer Investigational Site Mexico DF Mexico 06720
    186 Pfizer Investigational Site Mexico DF Mexico 14000
    187 Pfizer Investigational Site Toluca Estado de Mexico Mexico 50180
    188 Pfizer Investigational Site Guadalajara Jalisco Mexico 44240
    189 Pfizer Investigational Site Merida Yucatan Mexico 97000
    190 Pfizer Investigational Site Chihuahua Mexico 31000
    191 Pfizer Investigational Site Puebla Mexico 72530
    192 Pfizer Investigational Site Groningen GR Netherlands 9713 GZ
    193 Pfizer Investigational Site Amsterdam NH Netherlands 1066 CX
    194 Pfizer Investigational Site Amsterdam Netherlands 1081 HV
    195 Pfizer Investigational Site Rotterdam Netherlands 3075 EA
    196 Pfizer Investigational Site Oslo Norway 0310
    197 Pfizer Investigational Site Ciudad de Panama Panama
    198 Pfizer Investigational Site Panama Panama
    199 Pfizer Investigational Site Lima Peru 11
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    201 Pfizer Investigational Site Quezon City Philippines 1102
    202 Pfizer Investigational Site Quezon City Philippines
    203 Pfizer Investigational Site Gdansk Poland 80-210
    204 Pfizer Investigational Site Lodz Poland 93-509
    205 Pfizer Investigational Site Poznan Poland 60-569
    206 Pfizer Investigational Site Warszawa Poland 00-909
    207 Pfizer Investigational Site Wroclaw Poland 50-556
    208 Pfizer Investigational Site Lisboa Portugal 1070-213
    209 Pfizer Investigational Site Porto Portugal 4200-319
    210 Pfizer Investigational Site Bucuresti Romania 022328
    211 Pfizer Investigational Site Cluj-Napoca Romania 400015
    212 Pfizer Investigational Site Obninsk Kaluga region Russian Federation 249036
    213 Pfizer Investigational Site Chelyabinsk Russian Federation 454087
    214 Pfizer Investigational Site Moscow Russian Federation 115478
    215 Pfizer Investigational Site Belgrade Serbia 11000
    216 Pfizer Investigational Site Singapore Singapore 169610
    217 Pfizer Investigational Site Bratislava Slovakia 83301
    218 Pfizer Investigational Site Zilina Slovakia 012 07
    219 Pfizer Investigational Site Ljubljana Slovenia 1000 Ljubljana
    220 Pfizer Investigational Site Oviedo Asturias Spain 33006
    221 Pfizer Investigational Site L'hospitalet Del Llobregat Barcelona Spain 08907
    222 Pfizer Investigational Site Pamplona Navarra Spain 31008
    223 Pfizer Investigational Site Baracaldo Vizcaya Spain 48903
    224 Pfizer Investigational Site Barcelona Spain 08025
    225 Pfizer Investigational Site Barcelona Spain 08035
    226 Pfizer Investigational Site La Coruña Spain 15006
    227 Pfizer Investigational Site Madrid Spain 28007
    228 Pfizer Investigational Site Madrid Spain 28040
    229 Pfizer Investigational Site Madrid Spain 28041
    230 Pfizer Investigational Site Salamanca Spain 37007
    231 Pfizer Investigational Site Sevilla Spain 41013
    232 Pfizer Investigational Site Valencia Spain 46009
    233 Pfizer Investigational Site Göteborg Sweden 413 45
    234 Pfizer Investigational Site Lund Sweden 221 85
    235 Pfizer Investigational Site Stockholm Sweden 171 76
    236 Pfizer Investigational Site Umeå Sweden 901 85
    237 Pfizer Investigational Site Basel Switzerland CH-4056
    238 Pfizer Investigational Site Bellinzona Switzerland CH-6500
    239 Pfizer Investigational Site Bern Switzerland 3010
    240 Pfizer Investigational Site Biel Switzerland 2500
    241 Pfizer Investigational Site CH-4058 Basel Switzerland
    242 Pfizer Investigational Site CH-4101 Bruderholz Switzerland
    243 Pfizer Investigational Site CH-4410 Liesthal Switzerland
    244 Pfizer Investigational Site Chur Switzerland CH-7000
    245 Pfizer Investigational Site Genève 14 Switzerland CH-1211
    246 Pfizer Investigational Site Taipei Taiwan 100
    247 Pfizer Investigational Site Taipei Taiwan 112
    248 Pfizer Investigational Site Taoyun Taiwan 333
    249 Pfizer Investigational Site Bangkok Thailand 10330
    250 Pfizer Investigational Site Bangkok Thailand 10700
    251 Pfizer Investigational Site Istanbul Capa Turkey 34390
    252 Pfizer Investigational Site Istanbul Cerrahpasa Turkey 34303
    253 Pfizer Investigational Site Whitchurch Cardiff United Kingdom CF14 2TL
    254 Pfizer Investigational Site London Se1 9rt United Kingdom
    255 Pfizer Investigational Site Sutton Surrey United Kingdom SM2 5PT
    256 Pfizer Investigational Site Leeds West Yorkshire United Kingdom LS9 7TF
    257 Pfizer Investigational Site Belfast United Kingdom BT9 7AB
    258 Pfizer Investigational Site Birmingham United Kingdom B15 2TH
    259 Pfizer Investigational Site Birmingham United Kingdom B15 2TT
    260 Pfizer Investigational Site Bristol United Kingdom BS2 8ED
    261 Pfizer Investigational Site Cottingham United Kingdom HU16 5JQ
    262 Pfizer Investigational Site Edinburgh United Kingdom EH4 2XU
    263 Pfizer Investigational Site Guildford United Kingdom GU2 5XX
    264 Pfizer Investigational Site London United Kingdom EC1A 7BE
    265 Pfizer Investigational Site London United Kingdom NW3 2Qg
    266 Pfizer Investigational Site London United Kingdom SW3 6JJ
    267 Pfizer Investigational Site Manchester United Kingdom M20 4BX
    268 Pfizer Investigational Site Northwood United Kingdom HA6 2RN
    269 Pfizer Investigational Site Nottingham United Kingdom NG5 1PB
    270 Pfizer Investigational Site Sheffield United Kingdom S10 2SJ
    271 Pfizer Investigational Site Southampton United Kingdom SO16 6YD
    272 Pfizer Investigational Site Swansea United Kingdom SA2 8QA
    273 Pfizer Investigational Site Caracas Distrito Capital Venezuela 1040
    274 Pfizer Investigational Site Caracas Estado Miranda Venezuela 1060

    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:
    NCT00130897
    Other Study ID Numbers:
    • A6181037
    First Posted:
    Aug 16, 2005
    Last Update Posted:
    Mar 9, 2012
    Last Verified:
    Mar 1, 2012
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 9, 2012