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A Treatment Protocol for Patients With Gastrointestinal Stromal Tumor (GIST) Who May Derive Benefit From Treatment With SU011248

Sponsor
Pfizer (Industry)
Overall Status
Approved for marketing
CT.gov ID
NCT00094029
Collaborator
(none)
118
Locations
85
Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to permit access to SU011248 for treatment use by patients with GIST given the following conditions: a) patients undergo screening, but are not eligible for participation in ongoing clinical studies such as A6181004; AND b) patients have GIST which standard treatments have not been able to control with acceptable toxicity AND c) patients have the potential to derive clinical benefit from treatment with SU011248.

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 A6181036 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 Treatment Protocol For Patients With Gastrointestinal Stromal Tumor Who Are Ineligible For Participation In Other SU011248 Protocols And Are Refractory To Or Intolerant Of Imatinib Mesylate
Study Start Date :
Sep 1, 2004
Actual Primary Completion Date :
Oct 1, 2011
Actual Study Completion Date :
Oct 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:

    • Histologically proven Gastrointestinal Stomal Tumor (GIST) that is not amenable to standard therapy

    • Undergone screening and found to be ineligible for participation in ongoing SU011248 clinical studies

    • Patient judged to have potential to derive clinical benefit from SU011248 treatment by the treating physician

    • Failed prior treatment with imatinib mesylate, defined as either progression of disease or significant toxicity during treatment with imatinib mesylate that precluded further treatment

    • Male or Female, 18 years or older

    • Resolution of all acute toxicities of prior therapies

    • Adequate organ function

    Exclusion Criteria:

    • Symptomatic congestive heart failure, myocardial infarction, or coronary artery bypass graft in the last 6 months, or ongoing severe or unstable angina or any unstable arrhythmia requiring medication

    • Symptomatic central nervous system metastases

    • Serious acute or chronic illness

    • Current treatment on another clinical trial

    • Pregnant or breastfeeding.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pfizer Investigational Site Duarte California United States 91010
    2 Pfizer Investigational Site Pasadena California United States 91105
    3 Pfizer Investigational Site San Francisco California United States 94115-1705
    4 Pfizer Investigational Site Santa Monica California United States 90404
    5 Pfizer Investigational Site Washington District of Columbia United States 20010-2931
    6 Pfizer Investigational Site Gainesville Florida United States 32610
    7 Pfizer Investigational Site Gainsville Florida United States 32610
    8 Pfizer Investigational Site Miami Florida United States 33136
    9 Pfizer Investigational Site Tampa Florida United States 33612
    10 Pfizer Investigational Site Niles Illinois United States 60714
    11 Pfizer Investigational Site Park Ridge Illinois United States 60068
    12 Pfizer Investigational Site Boston Massachusetts United States 02115
    13 Pfizer Investigational Site New Bedford Massachusetts United States 02741
    14 Pfizer Investigational Site Detroit Michigan United States 48201
    15 Pfizer Investigational Site Detroit Michigan United States 48202
    16 Pfizer Investigational Site Farmington Hills Michigan United States 48334
    17 Pfizer Investigational Site Minneapolis Minnesota United States 55455
    18 Pfizer Investigational Site Rochester Minnesota United States 55905
    19 Pfizer Investigational Site Creve Coeur Missouri United States 63141
    20 Pfizer Investigational Site St. Louis Missouri United States 63110-1010
    21 Pfizer Investigational Site St. Louis Missouri United States 63110-1094
    22 Pfizer Investigational Site Bronx New York United States 10466
    23 Pfizer Investigational Site Buffalo New York United States 14263
    24 Pfizer Investigational Site New York New York United States 10022
    25 Pfizer Investigational Site New York New York United States 10032
    26 Pfizer Investigational Site Durham North Carolina United States 27710
    27 Pfizer Investigational Site Portland Oregon United States 97201
    28 Pfizer Investigational Site Portland Oregon United States 97239
    29 Pfizer Investigational Site Dallas Texas United States 75246
    30 Pfizer Investigational Site Seattle Washington United States 98109
    31 Pfizer Investigational Site Seattle Washington United States 98195
    32 Pfizer Investigational Site Madison Wisconsin United States 53792
    33 Pfizer Investigational Site Burnos Aires Argentina C1426ANZ
    34 Pfizer Investigational Site Camperdown New South Wales Australia 2050
    35 Pfizer Investigational Site Randwick New South Wales Australia 2031
    36 Pfizer Investigational Site Auchenflower Queensland Australia 4066
    37 Pfizer Investigational Site Bedford Park South Australia Australia 5042
    38 Pfizer Investigational Site East Melbourne Victoria Australia 3002
    39 Pfizer Investigational Site Nedlands Western Australia Australia 6009
    40 Pfizer Investigational Site Ashford SA Australia 5035
    41 Pfizer Investigational Site Auchenflower QLD Australia 4066
    42 Pfizer Investigational Site Graz Austria A-8036
    43 Pfizer Investigational Site Wien Austria 1100
    44 Pfizer Investigational Site Brussels Belgium 1200
    45 Pfizer Investigational Site Leuven Belgium 3000
    46 Pfizer Investigational Site Calgary Alberta Canada T2N 4N2
    47 Pfizer Investigational Site Vancouver British Columbia Canada V5Z 4E6
    48 Pfizer Investigational Site Winnipeg Manitoba Canada R2H 2A6
    49 Pfizer Investigational Site St. John's Newfoundland and Labrador Canada A1B 3V6
    50 Pfizer Investigational Site Toronto Ontario Canada M5G 1X5
    51 Pfizer Investigational Site Montreal Quebec Canada H2L 4M1
    52 Pfizer Investigational Site Santiago RM Chile
    53 Pfizer Investigational Site Bogota Cundinamarca Colombia
    54 Pfizer Investigational Site Brno Czech Republic 656 53
    55 Pfizer Investigational Site Praha 5 Czech Republic 150 06
    56 Pfizer Investigational Site Aarhus C Denmark 8000
    57 Pfizer Investigational Site Herlev Denmark 2730
    58 Pfizer Investigational Site Helsinki Finland 00029 HUS
    59 Pfizer Investigational Site Bordeaux Cedex France 33076
    60 Pfizer Investigational Site Lyon France 69373
    61 Pfizer Investigational Site Marseille France 13385
    62 Pfizer Investigational Site Berlin Germany 13125
    63 Pfizer Investigational Site Duesseldorf Germany 40479
    64 Pfizer Investigational Site Koeln Germany 50937
    65 Pfizer Investigational Site Muenchen Germany 81377
    66 Pfizer Investigational Site Thessaloniki Greece 54007
    67 Pfizer Investigational Site Happy Valley Hong Kong 0
    68 Pfizer Investigational Site Hong Kong Hong Kong
    69 Pfizer Investigational Site Budapest Hungary 1097
    70 Pfizer Investigational Site New Delhi Delhi India 110 029
    71 Pfizer Investigational Site Mumbai Maharashtra India 400 012
    72 Pfizer Investigational Site Vellore Tamil Nadu India 632 004
    73 Pfizer Investigational Site Tel Hashomer Israel 52621
    74 Pfizer Investigational Site Tel-Aviv Israel 64239
    75 Pfizer Investigational Site Aviano (PN) Italy 33081
    76 Pfizer Investigational Site Aviano, PN Italy 33081
    77 Pfizer Investigational Site Bologna Italy 40138
    78 Pfizer Investigational Site Candiolo (TO) Italy 10060
    79 Pfizer Investigational Site Genova Italy 16132
    80 Pfizer Investigational Site Milano Italy 20133
    81 Pfizer Investigational Site Milano Italy 20141
    82 Pfizer Investigational Site Milano Italy 20162
    83 Pfizer Investigational Site Torino Italy 10153
    84 Pfizer Investigational Site Seoul Korea, Republic of 110-744
    85 Pfizer Investigational Site Seoul Korea, Republic of 138-736
    86 Pfizer Investigational Site Mexico DF Mexico 14000
    87 Pfizer Investigational Site Guadalajara Jalisco Mexico 44240
    88 Pfizer Investigational Site Groningen Gr Netherlands 9713 GZ
    89 Pfizer Investigational Site Leiden Netherlands 2333 ZA
    90 Pfizer Investigational Site Oslo Norway 0310
    91 Pfizer Investigational Site Warszawa Poland 02-781
    92 Pfizer Investigational Site Singapore Singapore 169610
    93 Pfizer Investigational Site Singapore Singapore 308433
    94 Pfizer Investigational Site Bratislava Slovakia 833 10
    95 Pfizer Investigational Site Oviedo Asturias Spain 33006
    96 Pfizer Investigational Site L'Hospitalet de Llobregat Barcelona Spain 08907
    97 Pfizer Investigational Site Barcelona Spain 08025
    98 Pfizer Investigational Site Madrid Spain 28041
    99 Pfizer Investigational Site Sevilla Spain 41009
    100 Pfizer Investigational Site Valencia Spain 46009
    101 Pfizer Investigational Site Göteborg Sweden SE-431 45
    102 Pfizer Investigational Site Lausanne Switzerland CH-1011
    103 Pfizer Investigational Site Kaohsiung Hsien Taiwan 833
    104 Pfizer Investigational Site Taipei Taiwan 100
    105 Pfizer Investigational Site Taipei Taiwan 104
    106 Pfizer Investigational Site Taipei Taiwan 112
    107 Pfizer Investigational Site Ratchatawi Bangkok Thailand
    108 Pfizer Investigational Site Bangkok Thailand 10700
    109 Pfizer Investigational Site Ankara Turkey 06100
    110 Pfizer Investigational Site Inciralti / IZMIR Turkey 35340
    111 Pfizer Investigational Site Istanbul Turkey 34390
    112 Pfizer Investigational Site Leeds England United Kingdom LS9 7TF
    113 Pfizer Investigational Site London United Kingdom SW3 6JJ
    114 Pfizer Investigational Site London United Kingdom W1T 3AA
    115 Pfizer Investigational Site Manchester United Kingdom M20 4BX
    116 Pfizer Investigational Site Newcastle upon Tyne United Kingdom NE7 7DN
    117 Pfizer Investigational Site Newcastle-Upon-Tyne United Kingdom NE4 6BE
    118 Pfizer Investigational Site Caracas Distrito Capital Venezuela 1041

    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:
    NCT00094029
    Other Study ID Numbers:
    • A6181036
    First Posted:
    Oct 11, 2004
    Last Update Posted:
    Mar 9, 2012
    Last Verified:
    Mar 1, 2012
    Additional relevant MeSH terms:
    Gastrointestinal Stromal Tumors
    Gastrointestinal Neoplasms
    Digestive System Neoplasms
    Sunitinib

    Study Results

    No Results Posted as of Mar 9, 2012