A Study of SU11248 In Patients With Metastatic Breast Cancer Who Have Failed Selected Other Therapies.

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NCT00078000

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Study Location
Pfizer Investigational Site
Greenbrae, California, 94904, United States
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Contact
1-800-718-1021
[email protected]
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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Anthracycline and taxane-refractory or intolerant metastatic breast cancer

- Female

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Prior treatment with 3 or greater regimens of chemotherapy in the advanced/metastatic
disease setting beyond those containing anthracyclines/taxanes.

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  2. La Jolla, California
  3. San Diego, California
  4. Washington, District of Columbia
  5. Davie, Florida
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  7. Lexington, Kentucky
  8. Lexington, Kentucky
  9. Lexington, Kentucky
  10. Boston, Massachusetts
  11. Boston, Massachusetts
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  14. Boston, Massachusetts
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  16. Minneapolis, Minnesota
  17. Minneapolis, Minnesota
  18. Minneapolis, Minnesota
  19. Burlington, North Carolina
  20. Durham, North Carolina
  21. Durham, North Carolina
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  23. Durham, North Carolina
  24. Durham, North Carolina
  25. Dallas, Texas
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  27. Houston, Texas
  28. Burlington, Vermont
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  30. Burlington, Vermont
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  32. Burlington, Vermont
  33. Burlington, Vermont
  34. La Plata, Buenos Aires
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  36. La Plata, Buenos Aires
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  46. Montreal, QC
  47. Santo Cristo, Rio de Janeiro
  48. Porto Alegre, Rio Grande do Sul
  49. Rio de Janeiro, RJ
  50. Porto Alegre, RS
  51. Porto Alegre, RS
  52. Sao Paulo, SP
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  54. Rio De Janeiro,
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  56. Montreal, Quebec
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  3. Birmingham, Alabama
  4. Birmingham, Alabama
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  6. Birmingham, Alabama
  7. Daphne, Alabama
  8. Mobile, Alabama
  9. Mobile, Alabama
  10. Flagstaff, Arizona
  11. Sedona, Arizona
  12. Hot Springs, Arkansas
  13. Anaheim, California
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  15. Antioch, California
  16. Baldwin Park, California
  17. Bellflower, California
  18. Fontana, California
  19. Fountain Valley, California
  20. Gilroy, California
  21. Hawthorne, California
  22. Hayward, California
  23. Irvine, California
  24. La Jolla, California
  25. Long Beach, California
  26. Los Angeles, California
  27. Los Angeles, California
  28. Los Angeles, California
  29. Martinez, California
  30. Milpitas, California
  31. Modesto, California
  32. Mountain View, California
  33. Oakland, California
  34. Ontario, California
  35. Orange, California
  36. Oxnard, California
  37. Panorama City, California
  38. Pinole, California
  39. Riverside, California
  40. Sacramento, California
  41. San Diego, California
  42. San Diego, California
  43. San Francisco, California
  44. San Francisco, California
  45. San Francisco, California
  46. San Jose, California
  47. San Sacramento, California
  48. Santa Clara, California
  49. Santa Monica, California
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  51. Vallejo, California
  52. Walnut Creek, California
  53. Woodland Hills, California
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  55. Boulder, Colorado
  56. Colorado Springs, Colorado
  57. Colorado Springs, Colorado
  58. Denver, Colorado
  59. Denver, Colorado
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  62. Lone Tree, Colorado
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  64. Parker, Colorado
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  67. Boca Raton, Florida
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  76. Miami, Florida
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  84. Columbus, Georgia
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  90. Skokie, Illinois
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  94. Beech Grove, Indiana
  95. Carmel, Indiana
  96. Fishers, Indiana
  97. Greenfield, Indiana
  98. Indianapolis, Indiana
  99. Indianapolis, Indiana
  100. Indianapolis, Indiana
  101. Indianapolis, Indiana
  102. Indianapolis, Indiana
  103. Jeffersonville, Indiana
  104. Mooresville, Indiana
  105. Munster, Indiana
  106. New Albany, Indiana
  107. Kansas City, Kansas
  108. Overland Park, Kansas
  109. Louisville, Kentucky
  110. Louisville, Kentucky
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  112. Louisville, Kentucky
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  117. Baltimore, Maryland
  118. Baltimore, Maryland
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  128. Kansas City, Missouri
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  136. Lincoln, Nebraska
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  141. Las Vegas, Nevada
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  147. Albuquerque, New Mexico
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  149. Corning, New York
  150. Jamaica, New York
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  153. Clinton, North Carolina
  154. Durham, North Carolina
  155. Goldsboro, North Carolina
  156. Hickory, North Carolina
  157. Kenansville, North Carolina
  158. Kinston, North Carolina
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  161. Raleight, North Carolina
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  27. Shreveport, Louisiana
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  80. Linz,
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  94. Montreal, Quebec
  95. Montreal, Quebec
  96. Praha 4,
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  106. Lyon,
  107. Nancy,
  108. Paris,
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  112. Fuerstenwalde,
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  125. Dublin,
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  130. Milano,
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  132. Parma,
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  135. Saronno (VA),
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  137. Amsterdam,
  138. Sittard-geleen,
  139. Zwolle,
  140. Levanger,
  141. Oslo,
  142. Lodz,
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  144. Warszawa,
  145. Warszawa,
  146. Cluj-Napoca, Cluj
  147. Bucuresti, Sector 2
  148. Kuzmolovo, Vsevolozhsk district, Leningrad region
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  150. St. Petersburg,
  151. St. Petersburg,
  152. Barcelona,
  153. Burgos,
  154. Cadiz,
  155. La Coruña,
  156. Madrid,
  157. Madrid,
  158. Sevilla,
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  160. Chelmsford, Essex
  161. Harlow, Essex
  162. Burton upon Trent, Staffordshire
  163. Worthing, West Sussex
  164. Birmingham,
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  166. London,
  167. Swansea,
  168. Truro,
  169. Worthing,
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  1. Marseille, Be1 01971
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  3. Rennes, Be1 03677
  4. Brest, Be1 04292
  5. Aix en Provence,
  6. Amiens,
  7. Annecy Cedex,
  8. Avignon Cedex 2,
  9. Bayonne,
  10. Blois,
  11. Bordeaux CEDEX,
  12. Bordeaux,
  13. Brest,
  14. Cagne sur Mer,
  15. Chalon sur Saone,
  16. Chaumont,
  17. Croix,
  18. Dijon,
  19. Douai,
  20. Draguignan,
  21. Dunkerque,
  22. Evreux,
  23. Hyres,
  24. L'Union,
  25. Le Havre,
  26. Lille,
  27. Lorient,
  28. Lyon,
  29. Mareuil les Meaux,
  30. Marseille,
  31. Marseille,
  32. Marseille,
  33. Metz,
  34. Montauban,
  35. Montbeliard,
  36. Montelimar,
  37. Montpellier,
  38. Mougins,
  39. Nancy,
  40. Nantes Cedex 2,
  41. Neuilly,
  42. NICE Cedex 1,
  43. Nimes,
  44. Paris,
  45. Pessac,
  46. Quincy sous Senart,
  47. Reims,
  48. Ris Orangis,
  49. Saint Brieuc,
  50. Saint Nazaire,
  51. St Cloud,
  52. St Herblain,
  53. Strasbourg,
  54. Toulon,
  55. Toulouse,
  56. Toulouse,
  57. Vandoeuvre les Nancy,
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  59. Vannes,
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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study of SU11248 In Patients With Metastatic Breast Cancer Who Have Failed Selected Other Therapies.
Official Title  ICMJE A Phase 2 Study Of The Efficacy And Safety Of SU011248 In Patients With Metastatic Breast Cancer
Brief Summary Assessment of safety and efficacy of SU11248 in patients with metastatic breast cancer who have failed selected other therapies.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE Drug: SU011248
Study Arms  ICMJE Not Provided
Publications * Keyvanjah K, DePrimo SE, Harmon CS, Huang X, Kern KA, Carley W. Soluble KIT correlates with clinical outcome in patients with metastatic breast cancer treated with sunitinib. J Transl Med. 2012 Aug 16;10:165. doi: 10.1186/1479-5876-10-165.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 22, 2005)		64
Original Enrollment  ICMJE
 (submitted: June 23, 2005)		63
Actual Study Completion Date  ICMJE November 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Anthracycline and taxane-refractory or intolerant metastatic breast cancer
  • Female

Exclusion Criteria:

  • Prior treatment with 3 or greater regimens of chemotherapy in the advanced/metastatic disease setting beyond those containing anthracyclines/taxanes.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00078000
Other Study ID Numbers  ICMJE A6181002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP