An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene

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NCT00932451

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Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233, 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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1-800-718-1021

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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

- histologically or cytologically proven diagnosis of non-small cell lung cancer

- positive for the ALK fusion gene (test provided by either a central laboratory. Local laboratory may be used for certain cases)

- may have received pemetrexed or docetaxel from previous Phase 3 trial (A8081007) and discontinued treatment due to Response Evaluation Criterion in Solid Tumors (RECIST)-defined progression. or, once the primary endpoint of Study A8081007 has been analyzed and the results made available, at any time without RECIST-defined progression.

- Tumors can be measurable or non measurable

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


- prior treatment with PF-02341066


- received no prior systemic treatment, chemotherapy or EGFR tyrosine kinase inhibitor,
for advanced non-small cell lung cancer


- current enrollment in another therapeutic clinical trial

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Non-Small-Cell Lung CarcinomaAn Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
NCT00932451
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Little Rock, Arkansas
  4. Bakersfield, California
  5. Beverly Hills, California
  6. Beverly Hills, California
  7. La Jolla, California
  8. La Jolla, California
  9. Los Angeles, California
  10. Los Angeles, California
  11. Los Angeles, California
  12. Los Angeles, California
  13. Orange, California
  14. Orange, California
  15. Palo Alto, California
  16. Sacramento, California
  17. Sacramento, California
  18. San Diego, California
  19. Santa Monica, California
  20. Santa Monica, California
  21. Santa Monica, California
  22. Santa Rosa, California
  23. Aurora, Colorado
  24. Aurora, Colorado
  25. Aurora, Colorado
  26. Denver, Colorado
  27. Lafayette, Colorado
  28. New Haven, Connecticut
  29. New Haven, Connecticut
  30. New Haven, Connecticut
  31. Fort Lauderdale, Florida
  32. Hollywood, Florida
  33. Lake Worth, Florida
  34. Pembroke Pines, Florida
  35. Tampa, Florida
  36. Atlanta, Georgia
  37. Atlanta, Georgia
  38. Atlanta, Georgia
  39. Atlanta, Georgia
  40. Atlanta, Georgia
  41. Atlanta, Georgia
  42. Augusta, Georgia
  43. Augusta, Georgia
  44. Augusta, Georgia
  45. Decatur, Georgia
  46. Macon, Georgia
  47. Marietta, Georgia
  48. Sandy Springs, Georgia
  49. Honolulu, Hawaii
  50. Honolulu, Hawaii
  51. Honolulu, Hawaii
  52. Chicago, Illinois
  53. Chicago, Illinois
  54. Chicago, Illinois
  55. Harvey, Illinois
  56. Harvey, Illinois
  57. Harvey, Illinois
  58. Tinley Park, Illinois
  59. Indianapolis, Indiana
  60. Indianapolis, Indiana
  61. Indianapolis, Indiana
  62. Indianapolis, Indiana
  63. Indianopolis, Indiana
  64. Munster, Indiana
  65. Munster, Indiana
  66. Baltimore, Maryland
  67. Baltimore, Maryland
  68. Bethesda, Maryland
  69. Boston, Massachusetts
  70. Boston, Massachusetts
  71. Boston, Massachusetts
  72. Boston, Massachusetts
  73. Boston, Massachusetts
  74. Boston, Massachusetts
  75. Boston, Massachusetts
  76. Detroit, Michigan
  77. Farmington Hills, Michigan
  78. St. Louis, Missouri
  79. St. Louis, Missouri
  80. St. Peters, Missouri
  81. Omaha, Nebraska
  82. Lebanon, New Hampshire
  83. Albuquerque, New Mexico
  84. Albuquerque, New Mexico
  85. Lake Success, New York
  86. Manhasset, New York
  87. New Hyde Park, New York
  88. New York, New York
  89. New York, New York
  90. New York, New York
  91. New York, New York
  92. Oneida, New York
  93. Oswego, New York
  94. Syracuse, New York
  95. Syracuse, New York
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  97. Chapel Hill, North Carolina
  98. Charlotte, North Carolina
  99. Huntersville, North Carolina
  100. Huntersville, North Carolina
  101. Matthews, North Carolina
  102. Cleveland, Ohio
  103. Columbus, Ohio
  104. Columbus, Ohio
  105. Columbus, Ohio
  106. Columbus, Ohio
  107. Portland, Oregon
  108. Hershey, Pennsylvania
  109. Philadelphia, Pennsylvania
  110. Philadelphia, Pennsylvania
  111. Philadelphia, Pennsylvania
  112. Pittsburgh, Pennsylvania
  113. East Providence, Rhode Island
  114. East Providence, Rhode Island
  115. Charleston, South Carolina
  116. Dickson, Tennessee
  117. Franklin, Tennessee
  118. Gallatin, Tennessee
  119. Hermitage, 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. Nashville, Tennessee
  130. Smyrna, Tennessee
  131. Dallas, Texas
  132. Dallas, Texas
  133. Dallas, Texas
  134. Dallas, Texas
  135. Houston, Texas
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  137. Seattle, Washington
  138. Seattle, Washington
  139. Seattle, Washington
  140. Seattle, Washington
  141. Camperdown, New South Wales
  142. Adelaide, South Australia
  143. East Melbourne, Victoria
  144. Nedlands, Western Australia
  145. Salvador, Bahia
  146. Rio de Janeiro, RJ
  147. Ijui, RS
  148. Porto Alegre, RS
  149. Porto Alegre, RS
  150. Jau, Sao Paulo
  151. Barretos, SP
  152. Sao Paulo, SP
  153. Sao Paulo, SP
  154. Sofia,
  155. Sofia,
  156. Sofia,
  157. Varna,
  158. Calgary, Alberta
  159. Calgary, Alberta
  160. Calgary, Alberta
  161. Edmonton, Alberta
  162. Moncton, New Brunswick
  163. Moncton, New Brunswick
  164. Oshawa, Ontario
  165. Oshawa, Ontario
  166. Ottawa, Ontario
  167. Montreal, Quebec
  168. Montreal, Quebec
  169. Montreal, Quebec
  170. Montreal, Quebec
  171. Montreal, Quebec
  172. Guangzhou, Guangdong
  173. Nanjing, Jiangsu
  174. Beijing,
  175. Beijing,
  176. Guangzhou,
  177. Shanghai,
  178. Shanghai,
  179. Shanghai,
  180. Shanghai,
  181. Caen Cedex 05,
  182. Dijon,
  183. Grenoble Cedex 09,
  184. Marseille Cedex 20,
  185. NICE Cedex 2,
  186. Paris cedex 20,
  187. Paris,
  188. St Herblain Cedex,
  189. Villejuif,
  190. Dresden,
  191. Essen,
  192. Grosshansdorf,
  193. Hamburg,
  194. Heidelberg,
  195. Koeln,
  196. Muenchen,
  197. Oldenburg,
  198. Wiesbaden,
  199. Heraklion, Crete
  200. Exohi, Thessaloniki
  201. Athens,
  202. Pokfulam,
  203. Shatin, New Territories,
  204. Tuen Mun, New Territories,
  205. Budapest,
  206. Budapest,
  207. Debrecen,
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  225. Monza,
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  227. Perugia,
  228. Roma,
  229. Torino,
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  236. Fukuoka,
  237. Kashiwa,
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  241. Seoul,
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  246. Olsztyn,
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  249. Poznan,
  250. Poznan,
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  254. Saint-Petersburg,
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Advanced Information
Descriptive Information
Brief Title  ICMJE An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene
Official Title  ICMJE Phase 2, Open-label Single Arm Study Of The Efficacy And Safety Of Pf-02341066 In Patients With Advanced Non-small Cell Lung Cancer (Nsclc) Harboring A Translocation Or Inversion Involving The Anaplastic Lymphoma Kinase (Alk) Gene Locus
Brief Summary This is a Phase 2 trial that will evaluate the safety and efficacy of PF-02341066 in patients with advanced non-small cell lung cancer with a specific gene profile involving the ALK gene. This trial will also allow patients from a Phase 3 trial who received standard of care chemotherapy (Study A8081007) to receive PF-02341066.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE Drug: PF-02341066
PF-02341066, 250 mg BID, will be administered orally on a continuous schedule
Study Arms  ICMJE Experimental: PF-0231066
Intervention: Drug: PF-02341066
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: November 17, 2016)		1069
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2009)		200
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • histologically or cytologically proven diagnosis of non-small cell lung cancer
  • positive for the ALK fusion gene (test provided by either a central laboratory. Local laboratory may be used for certain cases)
  • may have received pemetrexed or docetaxel from previous Phase 3 trial (A8081007) and discontinued treatment due to Response Evaluation Criterion in Solid Tumors (RECIST)-defined progression. or, once the primary endpoint of Study A8081007 has been analyzed and the results made available, at any time without RECIST-defined progression.
  • Tumors can be measurable or non measurable

Exclusion Criteria:

  • prior treatment with PF-02341066
  • received no prior systemic treatment, chemotherapy or EGFR tyrosine kinase inhibitor, for advanced non-small cell lung cancer
  • current enrollment in another therapeutic clinical trial
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,   Brazil,   Bulgaria,   Canada,   China,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Ireland,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Poland,   Russian Federation,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries Argentina
 
Administrative Information
NCT Number  ICMJE NCT00932451
Other Study ID Numbers  ICMJE A8081005
2009-012504-13 ( EudraCT Number )
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 November 2016

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