Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer

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NCT00920816

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Study Location
Advanced Medical Specialties
Miami, Florida, 33143, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Kidney 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

- Histologically documented metastatic renal cell cancer with a component of clear cell histology.

- Evidence of measurable disease.

- Patients with mRCC must have received no prior systemic first-line therapy or must have progressive disease per RECIST (version 1.0) after one prior systemic first line regimen for metastatic disease containing sunitinib, cytokine(s), or both.

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


- Prior treatment for metastatic renal cell cancer with more that one systemic first
line therapy.


- Major surgery less that 4 weeks or radiation less than 2 weeks of starting study drug.

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  14. Whittier, California
  15. Aurora, Colorado
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  18. Boulder, Colorado
  19. Colorado Springs, Colorado
  20. Denver, Colorado
  21. Denver, Colorado
  22. Lakewood, Colorado
  23. Littleton, Colorado
  24. Lone Tree, Colorado
  25. Longmont, Colorado
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  27. Thornton, Colorado
  28. Washington, District of Columbia
  29. Washington, District of Columbia
  30. Bonita Springs, Florida
  31. Bradenton, Florida
  32. Cape Coral, Florida
  33. Cape Coral, Florida
  34. Deerfield Beach, Florida
  35. Englewood, Florida
  36. Fort Myers, Florida
  37. Fort Myers, Florida
  38. Fort Myers, Florida
  39. Fort Myers, Florida
  40. Miami, Florida
  41. Naples, Florida
  42. Naples, Florida
  43. Orlando, Florida
  44. Orlando, Florida
  45. Port Charlotte, Florida
  46. Sarasota, Florida
  47. Sarasota, Florida
  48. Venice, Florida
  49. Venice, Florida
  50. Atlanta, Georgia
  51. Ringgold, Georgia
  52. Boise, Idaho
  53. Fruitland, Idaho
  54. Meridian, Idaho
  55. Nampa, Idaho
  56. Twin Falls, Idaho
  57. Maywood, Illinois
  58. Carmel, Indiana
  59. Fishers, Indiana
  60. Greenfield, Indiana
  61. Indianapolis, Indiana
  62. Indianapolis, Indiana
  63. Boston, Massachusetts
  64. Boston, Massachusetts
  65. Ann Arbor, Michigan
  66. Detroit, Michigan
  67. Farmington Hills, Michigan
  68. Minneapolis, Minnesota
  69. Columbia, Missouri
  70. Saint Louis, Missouri
  71. Saint Louis, Missouri
  72. Washington, Missouri
  73. Henderson, Nevada
  74. Las Vegas, Nevada
  75. Las Vegas, Nevada
  76. Las Vegas, Nevada
  77. Las Vegas, Nevada
  78. Hackensack, New Jersey
  79. Hackensack, New Jersey
  80. Hackensack, New Jersey
  81. Bronx, New York
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  83. New York, New York
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  86. Syracuse, New York
  87. Syracuse, New York
  88. Cary, North Carolina
  89. Durham, North Carolina
  90. Durham, North Carolina
  91. Elizabeth City, North Carolina
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  95. Cleveland, Ohio
  96. Columbus, Ohio
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  100. Mentor, Ohio
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  105. Hershey, Pennsylvania
  106. Philadelphia, Pennsylvania
  107. Charleston, South Carolina
  108. Easley, South Carolina
  109. Greenville, South Carolina
  110. Greenville, South Carolina
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  113. Chattanooga, Tennessee
  114. Chattanooga, Tennessee
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  116. Franklin, Tennessee
  117. Gallatin, Tennessee
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  119. Hixson, Tennessee
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  137. Cedar Park, Texas
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  148. Webster, Texas
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  157. Virginia Beach, Virginia
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  159. Seattle, Washington
  160. Seattle, Washington
  161. Seattle, Washington
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  163. Kurralta Park, South Australia
  164. Ballarat, Victoria
  165. East Melbourne, Victoria
  166. Heidelberg West, Victoria
  167. Heidelberg, Victoria
  168. Wien,
  169. Wien,
  170. Rio de Janeiro, RJ
  171. Porto Alegre, RS
  172. Barretos, SP
  173. Sao Paulo, SP
  174. Calgary, Alberta
  175. Edmonton, Alberta
  176. Kelowna, British Columbia
  177. Moncton, New Brunswick
  178. St. John's, Newfoundland and Labrador
  179. Oshawa, Ontario
  180. Beijing, Chaoyang District
  181. Nanjing, Jiangsu
  182. Beijing, P.R.
  183. Xi'an, Shaanxi
  184. Guangzhou,
  185. Shanghai,
  186. Tianjin,
  187. Lyon, Cedex 08
  188. Bordeaux Cedex,
  189. CRETEIL Cedex,
  190. Marseille Cedex 09,
  191. Paris Cedex 15,
  192. Rennes,
  193. St Herblain Cedex,
  194. Tours Cedex 1,
  195. Vandoeuvre les Nancy,
  196. Villejuif Cedex,
  197. Aachen,
  198. Berlin,
  199. Essen,
  200. Hannover,
  201. Mainz,
  202. Muenchen,
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  1. Los Angeles, California
  2. Mission Hills, California
  3. Monterey Park, California
  4. Northridge, California
  5. San Francisco, California
  6. San Francisco, California
  7. Boston, Massachusetts
  8. Boston, Massachusetts
  9. Ann Arbor, Michigan
  10. Henderson, Nevada
  11. Las Vegas, Nevada
  12. Las Vegas, Nevada
  13. New York, New York
  14. Philadelphia, Pennsylvania
  15. Madison, Wisconsin
ALL GENDERS
18 Years+
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Kidney NeoplasmsAxitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer
NCT00920816
  1. Miami, Florida
  2. Miami, Florida
  3. Arlington Heights, Illinois
  4. Niles, Illinois
  5. Carmel, Indiana
  6. Fishers, Indiana
  7. Greenfield, Indiana
  8. Indianapolis, Indiana
  9. Indianapolis, Indiana
  10. Columbia, Missouri
  11. Omaha, Nebraska
  12. Henderson, Nevada
  13. Henderson, Nevada
  14. Henderson, Nevada
  15. Las Vegas, Nevada
  16. Las Vegas, Nevada
  17. Las Vegas, Nevada
  18. Morristown, New Jersey
  19. Parsippany, New Jersey
  20. Albany, New York
  21. Albany, New York
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  23. Rexford, New York
  24. Troy, New York
  25. Cary, North Carolina
  26. Raleigh, North Carolina
  27. Raleigh, North Carolina
  28. Portland, Oregon
  29. Portland, Oregon
  30. Portland, Oregon
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  32. Hershey, Pennsylvania
  33. Charleston, South Carolina
  34. Charleston, South Carolina
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  36. Beaumont, Texas
  37. Bedford, Texas
  38. Dallas, Texas
  39. Fort Worth, Texas
  40. Fort Worth, Texas
  41. Fort Worth, Texas
  42. Fort Worth, Texas
  43. Fort Worth, Texas
  44. Grapevine, Texas
  45. Kerrville, Texas
  46. McAllen, Texas
  47. Midland, Texas
  48. San Antonio, Texas
  49. San Antonio, Texas
  50. Webster, Texas
  51. Weslaco, Texas
  52. Christiansburg, Virginia
  53. Low Moor, Virginia
  54. Roanoke, Virginia
  55. Salem, Virginia
  56. Wytheville, Virginia
  57. Vancouver, Washington
  58. Vancouver, Washington
  59. Wenatchee, Washington
  60. Banja Luka,
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  62. Tuzla,
  63. Sofia,
  64. Varna,
  65. Temuco, Cautin
  66. Temuco, IX Region
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  70. Haidian District, Beijing
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  74. Nanjing, Jiangsu
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  76. Changchun, Jilin
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  90. Bangalore, Karnataka
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  102. Toluca, Estado DE Mexico
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  108. Makati City,
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  110. Timisoara, JUD. Timis
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  114. Moscow,
  115. Ryazan,
  116. Ryazan,
  117. Saint-Petersburg,
  118. Ufa,
  119. Port Elizabeth,
  120. Taichung,
  121. Taipei,
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  125. Lviv,
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  1. San Francisco, California
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  4. New York, New York
  5. Cleveland, Ohio
  6. Philadelphia, Pennsylvania
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Advanced Information
Descriptive Information
Brief Title  ICMJE Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer
Official Title  ICMJE A4061051 (AXITINIB) FOR THE TREATMENT OF METASTATIC RENAL CELL CANCER
Brief Summary The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Kidney Neoplasms
Intervention  ICMJE
  • Drug: Axitinib (AG-013736)
    axitinib will be given at a starting dose of 5 mg BID with continuous dosing
  • Drug: Sorafenib
    sorafenib will be given at a dose of 400 mg BID continuous dosing
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Axitinib (AG-013736)
  • Active Comparator: B
    Intervention: Drug: Sorafenib
Publications *

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 31, 2013)		492
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2009)		200
Estimated Study Completion Date  ICMJE September 30, 2020
Actual Primary Completion Date July 27, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically documented metastatic renal cell cancer with a component of clear cell histology.
  • Evidence of measurable disease.
  • Patients with mRCC must have received no prior systemic first-line therapy or must have progressive disease per RECIST (version 1.0) after one prior systemic first line regimen for metastatic disease containing sunitinib, cytokine(s), or both.

Exclusion Criteria:

  • Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy.
  • Major surgery less that 4 weeks or radiation less than 2 weeks of starting study drug.
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 Bosnia and Herzegovina,   Bulgaria,   Chile,   China,   India,   Malaysia,   Mexico,   Philippines,   Romania,   Russian Federation,   South Africa,   Taiwan,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00920816
Other Study ID Numbers  ICMJE A4061051
2010-018585-23 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date September 2020

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