Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib

NCT00474786

Last updated date
Study Location
Pfizer Investigational Site
Duarte, California, 91010, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

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

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
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 confirmed diagnosis of mRCC (regardless of histology or nephrectomy status) with well-documented Radiological PD by RECIST criteria or clinical PD as judged by the investigator while receiving first-line sunitinib therapy. Subjects must have at least 1 cycle of sunitinib therapy (minimum of four weeks continuously).

- At time of randomization, at least 2 weeks since prior treatment with sunitinib, palliative radiation therapy, and/or surgery.

- At time of randomization, there must be at least 1 measurable lesion per RECIST. Lesions that have been previously irradiated or embolized cannot be selected as target lesions.

- More criteria apply

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


- Metastatic CNS from RCC.


- Subjects who discontinued Sutent therapy due specifically to intolerance.


- Prior systemic therapy for mRCC other than sunitinib.


- Active ketonuria, secondary to poorly controlled diabetes mellitus


- More criteria apply

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Renal Cell CarcinomaAxitinib (AG-013736) With Or Without Dose Titration (Increase) In Patients With Kidney Cancer
NCT00835978
  1. Antioch, California
  2. Bakersfield, California
  3. Pleasant Hill, California
  4. Pleasant Hill, California
  5. Pleasant Hill, California
  6. San Leandro, California
  7. Tampa, Florida
  8. Indianapolis, Indiana
  9. Indianapolis, Indiana
  10. Indianapolis, Indiana
  11. Baltimore, Maryland
  12. Baltimore, Maryland
  13. Baltimore, Maryland
  14. Boston, Massachusetts
  15. Boston, Massachusetts
  16. Grand Rapids, Michigan
  17. Saint Louis, Missouri
  18. Saint Louis, Missouri
  19. Omaha, Nebraska
  20. Omaha, Nebraska
  21. Las Vegas, Nevada
  22. Cincinnati, Ohio
  23. Cincinnati, Ohio
  24. Cleveland, Ohio
  25. Columbus, Ohio
  26. Columbus, Ohio
  27. West Chester, Ohio
  28. Portland, Oregon
  29. Dallas, Texas
  30. Houston, Texas
  31. Seattle, Washington
  32. Brno, CZE
  33. Olomouc,
  34. Praha 8,
  35. Usti nad Labem,
  36. Duesseldorf,
  37. Frankfurt,
  38. Hannover,
  39. Tuebingen,
  40. Weiden,
  41. Nagoya, Aichi
  42. Sapporo, Hokkaido
  43. Sapporo, Hokkaido
  44. Kobe, Hyogo
  45. Osakasayama, Osaka
  46. Hamamatsu-City, Shizuoka
  47. Chuo-ku, Tokyo
  48. Koto-ku, Tokyo
  49. Shinjuku-ku, Tokyo
  50. Akita,
  51. Chiba,
  52. Fukuoka,
  53. Nagasaki,
  54. Tokushima,
  55. Yamagata,
  56. Obninsk, Kaluga Region
  57. Poselok Kuzmolovskiy, Vsevolozhskiy Region, Leningradskaya Oblast
  58. Moscow,
  59. Moscow,
  60. Saint-Petersburg,
  61. Saint-Petersburg,
  62. Samara,
  63. Madrid,
  64. Madrid,
  65. Madrid,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Renal Cell CarcinomaTreatment Use Study With Sunitinib (SU011248) For Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma
NCT00130897
  1. Scottsdale, Arizona
  2. San Francisco, California
  3. San Francisco, California
  4. Aurora, Colorado
  5. Norwalk, Connecticut
  6. Miami, Florida
  7. Ocala, Florida
  8. Tampa, Florida
  9. Atlanta, Georgia
  10. Maywood, Illinois
  11. Indianapolis, Indiana
  12. Council Bluffs, Iowa
  13. Covington, Louisiana
  14. Gretna, Louisiana
  15. Marrero, Louisiana
  16. Metairie, Louisiana
  17. Metairie, Louisiana
  18. New Orleans, Louisiana
  19. Baltimore, Maryland
  20. Boston, Massachusetts
  21. Boston, Massachusetts
  22. Boston, Massachusetts
  23. Detroit, Michigan
  24. Minneapolis, Minnesota
  25. Southaven, Mississippi
  26. Tupelo, Mississippi
  27. Columbia, Missouri
  28. Columbia, Missouri
  29. Omaha, Nebraska
  30. Bronx, New York
  31. New York, New York
  32. New York, New York
  33. Durham, North Carolina
  34. Cleveland, Ohio
  35. Norman, Oklahoma
  36. Oklahoma City, Oklahoma
  37. Oklahoma City, Oklahoma
  38. Oklahoma City, Oklahoma
  39. Oklahoma City, Oklahoma
  40. Tulsa, Oklahoma
  41. Tulsa, Oklahoma
  42. Portland, Oregon
  43. Portland, Oregon
  44. Hershey, Pennsylvania
  45. Memphis, Tennessee
  46. Memphis, Tennessee
  47. Dallas, Texas
  48. Salt Lake City, Utah
  49. Seattle, Washington
  50. Seattle, Washington
  51. Seattle, Washington
  52. Seattle, Washington
  53. Madison, Wisconsin
  54. Buenos Aires,
  55. Buenos Aires,
  56. Buenos Aires,
  57. Randwick, New South Wales
  58. St Leonards, New South Wales
  59. Westmead, New South Wales
  60. South Brisbane, Queensland
  61. Elizabeth Vale, South Australia
  62. Woodville South, South Australia
  63. East Melbourne, Victoria
  64. Heidelburg, Victoria
  65. Perth, Western Australia
  66. Innsbruck,
  67. Wien,
  68. Bruxelles,
  69. Bruxelles,
  70. Gent,
  71. Leuven,
  72. Liege,
  73. Wilrijk,
  74. Sarajevo,
  75. Salvador, BA
  76. Belo Horizonte, MG
  77. Porto Alegre, Rio Grande do Sul
  78. Rio de Janeiro, RJ
  79. Rio de Janeiro, RJ
  80. Porto Alegre, RS
  81. Jau, SP
  82. Jaú, SP
  83. Jaú, SP
  84. São Paulo, SP
  85. São Paulo, SP
  86. São Paulo, SP
  87. Sofia,
  88. Sofia,
  89. Calgary, Alberta
  90. Edmonton, Alberta
  91. Kelowna, British Columbia
  92. Vancouver, British Columbia
  93. Victoria, British Columbia
  94. Winnipeg, Manitoba
  95. Winnnipeg, Manitoba
  96. St. John's, Newfoundland and Labrador
  97. Halifax, Nova Scotia
  98. Halifax, Nova Scotia
  99. London, Ontario
  100. Toronto, Ontario
  101. Toronto, Ontario
  102. Montreal, Quebec
  103. Montreal, Quebec
  104. Quebec,
  105. Santiago, RM
  106. Bogotá, Cundinamarca
  107. Cali,
  108. Rijeka,
  109. Split,
  110. Brno,
  111. Hradec Kralove,
  112. Praha 5,
  113. Praha 8,
  114. Guayaquil, Guayas
  115. Quito, Pichincha
  116. Cairo,
  117. Giza,
  118. Turku,
  119. Lyon, Cedex 08
  120. Saint Herblain, Cedex
  121. Strasbourg, Cedex
  122. Bordeaux,
  123. Clermont Ferand,
  124. Marseille Cedex 9,
  125. Marseille,
  126. Montpellier,
  127. Paris Cedex 13,
  128. Paris,
  129. Reims,
  130. Rennes,
  131. Tours,
  132. Vandoeuvre les Nancy,
  133. Aachen,
  134. Berlin,
  135. Dresden,
  136. Essen,
  137. Frankfurt,
  138. Freiburg,
  139. Hamburg,
  140. Hannover,
  141. Homburg/Saar,
  142. Jena,
  143. Kassel,
  144. Muenchen,
  145. Nuernberg,
  146. Rostock,
  147. Ulm,
  148. Athens, Attiki
  149. Athens,
  150. Patras,
  151. Thessaloniki,
  152. Hong Hong,
  153. Budapest,
  154. New Delhi, Delhi
  155. Pune, Maharashtra
  156. Parel, Mumbai
  157. Jaipur, Rajasthan
  158. New Delhi,
  159. Dublin 24,
  160. Dublin,
  161. Jerusalem,
  162. Tel Hashomer,
  163. Bergamo,
  164. Brescia,
  165. Cattolica (RN),
  166. Cuneo,
  167. Legnago, VR,
  168. Modena,
  169. Napoli,
  170. Padova,
  171. Parma,
  172. Pavia,
  173. Perugia,
  174. Pordenone,
  175. Rimini,
  176. Roma,
  177. Roma,
  178. Roma,
  179. Torino,
  180. Seoul,
  181. Seoul,
  182. Beirut,
  183. Petaling Jaya, Selangor
  184. Kuala Lumpur,
  185. Mexico, DF
  186. Mexico, DF
  187. Toluca, Estado de Mexico
  188. Guadalajara, Jalisco
  189. Merida, Yucatan
  190. Chihuahua,
  191. Puebla,
  192. Groningen, GR
  193. Amsterdam, NH
  194. Amsterdam,
  195. Rotterdam,
  196. Oslo,
  197. Ciudad de Panama,
  198. Panama,
  199. Lima,
  200. Lima,
  201. Quezon City,
  202. Quezon City,
  203. Gdansk,
  204. Lodz,
  205. Poznan,
  206. Warszawa,
  207. Wroclaw,
  208. Lisboa,
  209. Porto,
  210. Bucuresti,
  211. Cluj-Napoca,
  212. Obninsk, Kaluga region
  213. Chelyabinsk,
  214. Moscow,
  215. Belgrade,
  216. Singapore,
  217. Bratislava,
  218. Zilina,
  219. Ljubljana,
  220. Oviedo, Asturias
  221. L'hospitalet Del Llobregat, Barcelona
  222. Pamplona, Navarra
  223. Baracaldo, Vizcaya
  224. Barcelona,
  225. Barcelona,
  226. La Coruña,
  227. Madrid,
  228. Madrid,
  229. Madrid,
  230. Salamanca,
  231. Sevilla,
  232. Valencia,
  233. Göteborg,
  234. Lund,
  235. Stockholm,
  236. Umeå,
  237. Basel,
  238. Bellinzona,
  239. Bern,
  240. Biel,
  241. CH-4058 Basel,
  242. CH-4101 Bruderholz,
  243. CH-4410 Liesthal,
  244. Chur,
  245. Genève 14,
  246. Taipei,
  247. Taipei,
  248. Taoyun,
  249. Bangkok,
  250. Bangkok,
  251. Istanbul, Capa
  252. Istanbul, Cerrahpasa
  253. Whitchurch, Cardiff
  254. London, Se1 9rt
  255. Sutton, Surrey
  256. Leeds, West Yorkshire
  257. Belfast,
  258. Birmingham,
  259. Birmingham,
  260. Bristol,
  261. Cottingham,
  262. Edinburgh,
  263. Guildford,
  264. London,
  265. London,
  266. London,
  267. Manchester,
  268. Northwood,
  269. Nottingham,
  270. Sheffield,
  271. Southampton,
  272. Swansea,
  273. Caracas, Distrito Capital
  274. Caracas, Estado Miranda
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Renal Cell CarcinomaSUTENT® In The First Line Treatment Of Renal Cell Carcinoma
NCT00460798
ALL GENDERS
0+
years
MULTIPLE SITES
Renal Cell CarcinomaA Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma.
NCT00077974
  1. Duarte, California
  2. Pasadena, California
  3. San Francisco, California
  4. Boston, Massachusetts
  5. Boston, Massachusetts
  6. Boston, Massachusetts
  7. Ann Arbor, Michigan
  8. Rochester, Minnesota
  9. New York, New York
  10. New York, New York
  11. Durham, North Carolina
  12. Cleveland, Ohio
  13. Portland, Oregon
  14. Philadelphia, Pennsylvania
  15. Madison, Wisconsin
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced RCC Who Have Failed First-Line Sunitinib
Official Title  ICMJE A Randomized Trial Of Temsirolimus Versus Sorafenib As Second-Line Therapy In Patients With Advanced Renal Cell Carcinoma Who Have Failed First-Line Sunitinib Therapy
Brief Summary This is an international, randomized, open-label, outpatient, multicenter study. Subjects will be assigned in a 1:1 ratio to 1 of 2 treatment arms: temsirolimus 25 mg once weekly by intravenous (IV) infusion or sorafenib 400 mg by mouth (PO) twice daily (BID). These investigational drugs will be administered in 6-week cycles for the duration of the study, up to 24 months. Subjects will be stratified by nephrectomy status, duration of response to sunitinib therapy, Memorial Sloan Kettering Cancer Center (MSKCC) prognostic group, and RCC tumor histology.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Renal Cell Carcinoma
Intervention  ICMJE
  • Drug: Sorafenib
    Subjects randomized to arm B will take sorafenib 400 mg (2 x 200 mg tablets) PO, BID (total daily dose of 800 mg).
  • Drug: temsirolimus (Torisel)
    Subjects randomized to arm A will receive temsirolimus (Torisel) 25 mg via IV infusion once weekly. This infusion is to be administered over a 30-60 minute period. Subjects are to be pre-treated with 25-50 mg IV diphenhydramine (or comparable IV antihistamine) approximately 30 minutes before temsirolimus infusion.
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Sorafenib
  • Experimental: 2
    Intervention: Drug: temsirolimus (Torisel)
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: June 18, 2012)
512
Original Enrollment  ICMJE
 (submitted: May 15, 2007)
440
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed diagnosis of mRCC (regardless of histology or nephrectomy status) with well-documented Radiological PD by RECIST criteria or clinical PD as judged by the investigator while receiving first-line sunitinib therapy. Subjects must have at least 1 cycle of sunitinib therapy (minimum of four weeks continuously).
  • At time of randomization, at least 2 weeks since prior treatment with sunitinib, palliative radiation therapy, and/or surgery.
  • At time of randomization, there must be at least 1 measurable lesion per RECIST. Lesions that have been previously irradiated or embolized cannot be selected as target lesions.

    • More criteria apply

Exclusion Criteria:

  • Metastatic CNS from RCC.
  • Subjects who discontinued Sutent therapy due specifically to intolerance.
  • Prior systemic therapy for mRCC other than sunitinib.
  • Active ketonuria, secondary to poorly controlled diabetes mellitus

    • More criteria apply
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 Argentina,   Australia,   Austria,   Canada,   Chile,   China,   Denmark,   Finland,   France,   Germany,   Hungary,   Italy,   Korea, Republic of,   Netherlands,   Singapore,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries Hong Kong
 
Administrative Information
NCT Number  ICMJE NCT00474786
Other Study ID Numbers  ICMJE 3066K1-404
B1771003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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 October 2013

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