PH 1 Evaluation Of Oral CI-1033 In Combination With Paclitaxel/ Carboplatin As 1st Line Chemotherapy In NSCLC Patients

Back to Search
Print
Bookmark Trial

NCT00174356

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Tampa, Florida, 33612, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

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.
Non-Small Cell Lung 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

- At least one target lesion that is unidimensionally measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST ; Appendix B.2 ) and has not been previously irradiated; a tumor that expresses at least one member of the erbB family of receptors (as determined by immunohistochemical evaluation by a Sponsor-designated core laboratory)

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


- Prior chemotherapy, biologic therapy, immunotherapy, treatment with Herceptin, or
treatment with investigational agents (including CI 1033); hormonal therapy within 28
days prior to baseline disease assessment (to exclude the possibility of a
hormone-withdrawal response); prior definitive radiation therapy to the primary cancer
site; not yet recovered from the acute effects of surgery or palliative radiotherapy;
brain metastases.

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]

Call Now

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.

Advanced Search

Based on your search, you may also be interested in

Non-Small Cell Lung CarcinomaA Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone
NCT00457392
  1. Florence, Alabama
  2. Muscle Shoals, Alabama
  3. Scottsdale, Arizona
  4. Hot Springs, Arkansas
  5. Antioch, California
  6. Burbank, California
  7. Downey, California
  8. Fresno, California
  9. La Jolla, California
  10. La Jolla, California
  11. Montebello, California
  12. Pleasant Hill, California
  13. San Diego, California
  14. San Leandro, California
  15. Whittier, California
  16. Fairfield, Connecticut
  17. Brooksville, Florida
  18. Cocoa Beach, Florida
  19. Fort Lauderdale, Florida
  20. Merritt Island, Florida
  21. Rockledge, Florida
  22. Titusville, Florida
  23. Athens, Georgia
  24. Aurora, Illinois
  25. Goshen, Indiana
  26. Indianapolis, Indiana
  27. Council Bluffs, Iowa
  28. Baton Rouge, Louisiana
  29. Lafayette, Louisiana
  30. Bethesda, Maryland
  31. Ann Arbor, Michigan
  32. Troy, Michigan
  33. Columbus, Mississippi
  34. Corinth, Mississippi
  35. Tupelo, Mississippi
  36. St. Louis, Missouri
  37. St. Peters, Missouri
  38. Omaha, Nebraska
  39. Las Vegas, Nevada
  40. Las Vegas, Nevada
  41. Jamaica, New York
  42. Norman, Oklahoma
  43. Oklahoma City, Oklahoma
  44. Oklahoma City, Oklahoma
  45. Oklahoma City, Oklahoma
  46. Tulsa, Oklahoma
  47. Tulsa, Oklahoma
  48. Tulsa, Oklahoma
  49. Lancaster, Pennsylvania
  50. Knoxville, Tennessee
  51. Beaumont, Texas
  52. Dallas, Texas
  53. Grapevine, Texas
  54. Irving, Texas
  55. Bountiful, Utah
  56. Layton, Utah
  57. Murray, Utah
  58. Provo, Utah
  59. Salt Lake City, Utah
  60. Salt Lake City, Utah
  61. Sandy, Utah
  62. West Valley, Utah
  63. Kennewick, Washington
  64. Buenos Aires, Capital Federal
  65. Ciudad Autonoma de Buenos Aires, Capital Federal
  66. Buenos Aires,
  67. Cordoba,
  68. Grimmenstein,
  69. Innsbruck,
  70. Linz,
  71. Bruxelles,
  72. Leuven,
  73. Liege,
  74. Rio de Janeiro, RJ
  75. Rio de Janeiro, RJ
  76. Porto Alegre, RS
  77. Barretos, SP
  78. Sao Paulo, SP
  79. Kingston, Ontario
  80. Kingston, Ontario
  81. Oshawa, Ontario
  82. Toronto, Ontario
  83. Toronto, Ontario
  84. Greenfield Park, Quebec
  85. Levis, Quebec
  86. Rimouski, Quebec
  87. Saskatoon, Saskatchewan
  88. Quebec,
  89. Independencia, Santiago, RM
  90. Providencia, Santiago, RM
  91. Santiago,
  92. Medellin, Antioquia
  93. Medellin, Antioquia
  94. Ceske Budejovice,
  95. Nova Ves pod Plesi,
  96. Olomouc,
  97. Ostrava-Poruba,
  98. Praha 2,
  99. Praha 8,
  100. Pribram V,
  101. Tabor,
  102. Usti nad Labem,
  103. Herlev,
  104. Hilleroed,
  105. Koebenhavn OE,
  106. Odense,
  107. Bad Berka,
  108. Berlin,
  109. Dresden,
  110. Ebensfeld,
  111. Essen,
  112. Gauting,
  113. Grosshansdorf,
  114. Halle (Saale),
  115. Heidelberg,
  116. Homburg,
  117. Mainz,
  118. Tuebingen,
  119. Wiesbaden,
  120. Heraklion, Crete
  121. Alexandroupoli,
  122. Athens,
  123. Kifisia, Athens,
  124. Kowloon,
  125. Shatin, NT,
  126. Tuen Mun,,
  127. Budapest,
  128. Deszk,
  129. Gyula,
  130. Matrahaza,
  131. Szekesfehervar,
  132. Zalaegerszeg-Pozva,
  133. Catania,
  134. Grosseto,
  135. Mantova,
  136. Milano,
  137. Milano,
  138. Monza (MI),
  139. Novara,
  140. Orbassano (TO),
  141. Parma,
  142. Roma,
  143. Rozzano (MI),
  144. Seoul,
  145. Seoul,
  146. Seoul,
  147. Seoul,
  148. Enschede, Ov
  149. 's-Hertogenbosch,
  150. Amsterdam,
  151. Arnhem,
  152. Harderwijk,
  153. Maastricht,
  154. Rotterdam,
  155. Rotterdam,
  156. Kristiansand S,
  157. Oslo,
  158. Stavanger,
  159. Tromso,
  160. Trondheim,
  161. Lodz,
  162. Opole,
  163. Otwock,
  164. Warszawa,
  165. Warszawa,
  166. Zielona Gora,
  167. Moscow,
  168. Moscow,
  169. St-Petersburg,
  170. St. Petersburg,
  171. Bratislava,
  172. Kosice,
  173. Kvetnica pri Poprade,
  174. Nitra-Zobor,
  175. Zilina,
  176. Sabadell, Barcelona
  177. Palma de Mallorca, Islas Baleares
  178. La Laguna, Santa Cruz de Tenerife
  179. Dos Hermanas, Sevilla
  180. Barcelona,
  181. La Coruña,
  182. Madrid,
  183. Malaga,
  184. Sevilla,
  185. Valencia,
  186. Genolier,
  187. Gwei Shan Township, Taoyuan County
  188. Taichung,
  189. Tainan,
  190. Pathumwan, Bangkok
  191. Amphoe Mueang, Chiang Mai
  192. Bangkok,
  193. Bebington, Wirral,
  194. Cambridge,
  195. Derby,
  196. Dundee,
  197. Keighley, West Yorkshire,
  198. London,
  199. London,
  200. Peterborough,
  201. Rhyl, Denbigshire,
  202. Sheffield,
  203. Southampton,
  204. Yeovil, Somerset,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Non-Small Cell Lung CarcinomaTrial of Pemetrexed With or Without PF-3512676 in Advanced Non-Small Cell Lung Cancer
NCT00321308
  1. Litchfield Park, Arizona
  2. Sun City, Arizona
  3. Bentonville, Arkansas
  4. Fayetteville, Arkansas
  5. Hudson, Florida
  6. New Port Richey, Florida
  7. Mahwah, New Jersey
  8. Midland Park, New Jersey
  9. Paramus, New Jersey
  10. Westwood, New Jersey
  11. Oneida, New York
  12. Oswego, New York
  13. Syracuse, New York
  14. Syracuse, New York
  15. Sylvania, Ohio
  16. Seattle, Washington
  17. Seattle, Washington
  18. Grosshansdorf,
  19. Mannheim,
  20. Torino,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Non-Small Cell Lung CarcinomaPH 1 Evaluation Of Oral CI-1033 In Combination With Paclitaxel/ Carboplatin As 1st Line Chemotherapy In NSCLC Patients
NCT00174356
  1. Tampa, Florida
  2. Park Ridge, Illinois
  3. Skokie, Illinois
  4. Louisville, Kentucky
  5. Louisville, Kentucky
  6. Houston, Texas
  7. Hamilton, Ontario
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE PH 1 Evaluation Of Oral CI-1033 In Combination With Paclitaxel/ Carboplatin As 1st Line Chemotherapy In NSCLC Patients
Official Title  ICMJE A Phase 1 Evaluation Of Oral CI-1033 In Combination With Paclitaxel And Carboplatin As First-Line Chemotherapy In Patients With Advanced Non-Small Cell Lung Cancer
Brief Summary The main purpose of this study is to evaluate the overall safety and maximum dose of CI 1033 in combination with paclitaxel and carboplatin in patients with NSCLC.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small Cell Lung
Intervention  ICMJE
  • Drug: CI 1033
  • Drug: PACLITAXEL
  • Drug: CARBOPLATIN
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   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
Enrollment  ICMJE
 (submitted: September 9, 2005)		39
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE October 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least one target lesion that is unidimensionally measurable as defined by Response Evaluation Criteria in Solid Tumors (RECIST ; Appendix B.2 ) and has not been previously irradiated; a tumor that expresses at least one member of the erbB family of receptors (as determined by immunohistochemical evaluation by a Sponsor-designated core laboratory)

Exclusion Criteria:

  • Prior chemotherapy, biologic therapy, immunotherapy, treatment with Herceptin, or treatment with investigational agents (including CI 1033); hormonal therapy within 28 days prior to baseline disease assessment (to exclude the possibility of a hormone-withdrawal response); prior definitive radiation therapy to the primary cancer site; not yet recovered from the acute effects of surgery or palliative radiotherapy; brain metastases.
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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00174356
Other Study ID Numbers  ICMJE A4161001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2006

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