Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer

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NCT00678392

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Study Location
East Valley Hematology and Oncology Medical Group
Burbank, California, 91505, 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:

By phone

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1-800-718-1021

By email

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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 or cytologically confirmed renal cell cancer with a component of clear cell subtype, with metastasis

- Evidence of measurable disease

- Must have failed one prior systemic first-line regimen for metastatic renal cell cancer

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 than 4 weeks or radiation less than 2 weeks of starting study drug

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  1. Burbank, California
  2. Burbank, California
  3. Downey, California
  4. Glendale, California
  5. Los Angeles, California
  6. Los Angeles, California
  7. Los Angeles, California
  8. Los Angeles, California
  9. Los Angeles, California
  10. Los Angeles, California
  11. Los Angeles, California
  12. Montebello, California
  13. West Covina, California
  14. Whittier, California
  15. Aurora, Colorado
  16. Aurora, Colorado
  17. Aurora, Colorado
  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
  26. Parker, Colorado
  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
  82. New York, New York
  83. New York, New York
  84. Oneida, New York
  85. Oswego, New York
  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
  92. Elizabeth City, North Carolina
  93. Raleigh, North Carolina
  94. Cleveland, Ohio
  95. Cleveland, Ohio
  96. Columbus, Ohio
  97. Columbus, Ohio
  98. Columbus, Ohio
  99. Mayfield Heights, Ohio
  100. Mentor, Ohio
  101. Orange Village, Ohio
  102. Westlake, Ohio
  103. Eugene, Oregon
  104. Springfield, Oregon
  105. Hershey, Pennsylvania
  106. Philadelphia, Pennsylvania
  107. Charleston, South Carolina
  108. Easley, South Carolina
  109. Greenville, South Carolina
  110. Greenville, South Carolina
  111. Seneca, South Carolina
  112. Spartanburg, South Carolina
  113. Chattanooga, Tennessee
  114. Chattanooga, Tennessee
  115. Franklin, Tennessee
  116. Franklin, Tennessee
  117. Gallatin, Tennessee
  118. Hermitage, Tennessee
  119. Hixson, Tennessee
  120. Lebanon, Tennessee
  121. Murfreesboro, Tennessee
  122. Nashville, Tennessee
  123. Nashville, Tennessee
  124. Nashville, Tennessee
  125. Nashville, Tennessee
  126. Nashville, Tennessee
  127. Nashville, Tennessee
  128. Nashville, Tennessee
  129. Smyrna, Tennessee
  130. Austin, Texas
  131. Austin, Texas
  132. Austin, Texas
  133. Austin, Texas
  134. Austin, Texas
  135. Austin, Texas
  136. Bedford, Texas
  137. Cedar Park, Texas
  138. Dallas, Texas
  139. Fort Worth, Texas
  140. Fort Worth, Texas
  141. Fort Worth, Texas
  142. Houston, Texas
  143. Houston, Texas
  144. Round Rock, Texas
  145. Round Rock, Texas
  146. Tyler, Texas
  147. Webster, Texas
  148. Webster, Texas
  149. Arlington, Virginia
  150. Chesapeake, Virginia
  151. Fairfax, Virginia
  152. Gainesville, Virginia
  153. Hampton, Virginia
  154. Leesburg, Virginia
  155. Newport News, Virginia
  156. Norfolk, Virginia
  157. Virginia Beach, Virginia
  158. Woodbridge, Virginia
  159. Seattle, Washington
  160. Seattle, Washington
  161. Seattle, Washington
  162. Garran, Australian Capital Territory
  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,
  203. Oldenburg,
  204. Athens, Attiki
  205. Thessaloniki, Macedonia
  206. Gurgaon, Haryana
  207. Kochi, Kerala
  208. Mumbai, Maharashtra
  209. Ludhiana, Punjab
  210. Jaipur, Rajasthan
  211. Dublin 24,
  212. Arezzo,
  213. Aviano (PN),
  214. Aviano (PN),
  215. Brescia,
  216. Cremona,
  217. Genova,
  218. Milano,
  219. Napoli,
  220. Napoli,
  221. Padova,
  222. Pavia,
  223. Roma,
  224. Roma,
  225. Rozzano (MI),
  226. Sapporo-shi, Hokkaido
  227. Sapporo, Hokkaido
  228. Tsukuba, Ibaraki
  229. Osakasayama, Osaka
  230. Hamamatsu-City, Shizuoka
  231. Sunto-gun, Shizuoka
  232. Arakawa-ku, Tokyo
  233. Chuo-Ku, Tokyo
  234. Itabashi-ku, Tokyo
  235. Shinjuku-ku, Tokyo
  236. Shinjuku-ku, Tokyo
  237. Ube-shi, Yamaguchi
  238. Akita,
  239. Chiba,
  240. Fukuoka,
  241. Kumamoto,
  242. Tokushima,
  243. Yamagata,
  244. Goyang-si, Gyeonggi-do
  245. Busan,
  246. Seoul,
  247. Seoul,
  248. Seoul,
  249. Seoul,
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  251. Poznan, Wielkopolska
  252. Gdansk,
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  264. Singapore,
  265. Bratislava,
  266. Bratislava,
  267. Zilina,
  268. L'hospitalet de Llobregat, Barcelona
  269. Pamplona, Navarra
  270. Pamplona, Navarra
  271. Barcelona,
  272. Madrid,
  273. Madrid,
  274. Malaga,
  275. Sevilla,
  276. Zaragoza,
  277. Linkoping,
  278. Umea,
  279. Vaxjo,
  280. Kaohsiung Hsien,
  281. Taichung,
  282. Taipei,
  283. Taoyuan,
  284. London, England
  285. Northwood, Middlesex
  286. Bebington, Wirral,
  287. Birmingham,
  288. Bournemouth,
  289. Bristol,
  290. Cambridge,
  291. Glasgow,
  292. London,
  293. Oxford,
  294. Surrey,
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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
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  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
  22. Latham, New York
  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
  31. Tualatin, Oregon
  32. Hershey, Pennsylvania
  33. Charleston, South Carolina
  34. Charleston, South Carolina
  35. Amarillo, Texas
  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. Grapevine, Texas
  44. Kerrville, Texas
  45. McAllen, Texas
  46. Midland, Texas
  47. San Antonio, Texas
  48. San Antonio, Texas
  49. Webster, Texas
  50. Weslaco, Texas
  51. Christiansburg, Virginia
  52. Low Moor, Virginia
  53. Roanoke, Virginia
  54. Salem, Virginia
  55. Wytheville, Virginia
  56. Vancouver, Washington
  57. Vancouver, Washington
  58. Wenatchee, Washington
  59. Banja Luka,
  60. Sarajevo,
  61. Tuzla,
  62. Sofia,
  63. Varna,
  64. Temuco, Cautin
  65. Temuco, IX Region
  66. Providencia, Santiago
  67. Santiago,
  68. Beijing, Beijing
  69. Haidian District, Beijing
  70. Fuzhou, Fujian
  71. Guangzhou, Guang DONG
  72. Guangzhou, Guangdong
  73. Nanjing, Jiangsu
  74. Nanjing, Jiangsu
  75. Changchun, Jilin
  76. Shen Yang, LIAO NING
  77. Xi'an, Shaanxi
  78. Shanghai, Shanghai
  79. Chengdu, Sichuan
  80. Hangzhou, Zhejiang
  81. Beijing,
  82. Beijing,
  83. Chongqing,
  84. Nanjing,
  85. Shanghai,
  86. Tianjin,
  87. Tianjin,
  88. Hyderabad, Andhra Pradesh
  89. Bangalore, Karnataka
  90. Bangalore, Karnataka
  91. Bangalore, Karnataka
  92. Nagpur, Maharashtra
  93. Nashik, Maharashtra
  94. Nashik, Maharashtra
  95. Pune, Maharashtra
  96. Pune, Maharashtra
  97. Bangalore,
  98. Kuala Lumpur,
  99. Mexico, DF
  100. Mexico City, Distrito Federal
  101. Toluca, Estado DE Mexico
  102. Aguascalientes,
  103. Oaxaca,
  104. Quezon City, Diliman
  105. Quezon City, Metro Manila
  106. Quezon City, Metro Manila
  107. Makati City,
  108. Manila,
  109. Timisoara, JUD. Timis
  110. Cluj-Napoca,
  111. Cluj-Napoca,
  112. Moscow,
  113. Moscow,
  114. Ryazan,
  115. Ryazan,
  116. Saint-Petersburg,
  117. Ufa,
  118. Port Elizabeth,
  119. Taichung,
  120. Taipei,
  121. Dnipro,
  122. Kharkiv,
  123. Kyiv,
  124. Lviv,
  125. Zaporizhzhya,
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years
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Advanced Information
Descriptive Information
Brief Title  ICMJE Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer
Official Title  ICMJE AXITINIB (AG-013736) AS SECOND LINE THERAPY FOR METASTATIC RENAL CELL CANCER: AXIS TRIAL
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 after failure of one first line regimen.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
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 twice daily [BID] with continuous dosing
  • Drug: Sorafenib
    sorafenib will be given at a dose of 400 mg twice daily [BID] with continuous dosing
Study Arms  ICMJE
  • Experimental: Axitinib
    Intervention: Drug: Axitinib (AG-013736)
  • Active Comparator: Sorafenib
    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 Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2011)		723
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2008)		540
Actual Study Completion Date  ICMJE February 25, 2016
Actual Primary Completion Date August 31, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed renal cell cancer with a component of clear cell subtype, with metastasis
  • Evidence of measurable disease
  • Must have failed one prior systemic first-line regimen for metastatic renal cell cancer

Exclusion Criteria:

  • Prior treatment for metastatic renal cell cancer with more that one systemic first line therapy
  • Major surgery less than 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 Australia,   Austria,   Brazil,   Canada,   China,   France,   Germany,   Greece,   India,   Ireland,   Italy,   Japan,   Korea, Republic of,   Poland,   Russian Federation,   Singapore,   Slovakia,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT00678392
Other Study ID Numbers  ICMJE A4061032
AXIS TRIAL
2008-001451-21 ( EudraCT Number )
AXIS ( Other Identifier: Alias Study 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 December 2018

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