Erlotinib Is Being Studied With Or Without An Investigational Drug, PF-02341066, In Patients With Lung Cancer

Back to Search
Print
Bookmark Trial

NCT00965731

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233, 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 Cancer
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 proven diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally advanced or metastatic and of the adenocarcinoma subtype (including mixed adenosquamous histology)

- evident disease progression by Response Evaluation Criterion in Solid Tumors (RECIST) after at least one but no more than 2 chemotherapy regimens for advanced disease

- tumors must have measurable disease as per RECIST

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


- known interstitial lung disease


- prior treatment with an agent that is known or proposed to be active by action on EGFR
tyrosine kinase or c-Met/HGF (Phase 2 Portion)

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
pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
Learn more ›

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 CancerStudy of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002)
NCT02920450
  1. Gainesville, Florida
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Non-Small Cell Lung CancerEffect of Celecoxib on Survival in Patients With Advanced Non-Small Cell Lung Cancer Receiving Chemotherapy
NCT00300729
  1. Gothenburg,
  2. Jönköping,
  3. Kalmar,
  4. Linköping,
  5. Lund,
  6. Malmö,
  7. Skövde,
  8. Trollhättan,
  9. Uddevalla,
  10. Umeå,
  11. Uppsala,
  12. Ystad,
  13. Örebro,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Non-Small Cell Lung CancerA Phase I Study of SUNITINIB and Rapamycin in Advanced Non-Small Cell Lung Cancer (NSCLC)
NCT00555256
  1. St. Louis, Missouri
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Non-small Cell Lung CancerAn Open-label Study of Encorafenib + Binimetinib in Patients With BRAFV600E-mutant Non-small Cell Lung Cancer
NCT03915951
  1. Boston, Massachusetts
  2. Middletown, New Jersey
  3. Pompton Plains, New Jersey
  4. Commack, New York
  5. Harrison, New York
  6. New York, New York
  7. New York, New York
  8. Uniondale, New York
  9. Houston, Texas
  10. Via Albertoni, Bologna
  11. Via Albertoni, Bologna
  12. Via Massarenti, Bologna
  13. Via Massarenti, Bologna
  14. Via Massarenti, Bologna
  15. Via Palagi, Bologna
  16. Milan, Lombardia
  17. Milan, Lombardia
  18. Milan, Lombardia
  19. Milan, Lombardia
  20. Milan, Lombardia
  21. Milan, Lombardia
  22. Milan, Lombardia
  23. Viale Pansini, Napli
  24. Amsterdam, Noord-holland
  25. Amsterdam,
  26. Groningen,
  27. Groningen,
  28. Cordoba,
  29. Los Angeles, California
  30. Santa Monica, California
  31. Norwich, Connecticut
  32. Norwich, Connecticut
  33. Altamonte Springs, Florida
  34. Bonita Springs, Florida
  35. Bradenton, Florida
  36. Brandon, Florida
  37. Cape Coral, Florida
  38. Clearwater, Florida
  39. Fleming Island, Florida
  40. Fort Myers, Florida
  41. Fort Myers, Florida
  42. Gainesville, Florida
  43. Largo, Florida
  44. Lecanto, Florida
  45. Naples, Florida
  46. New Port Richey, Florida
  47. Ocala, Florida
  48. Orange City, Florida
  49. Orlando, Florida
  50. Port Charlotte, Florida
  51. Saint Petersburg, Florida
  52. Saint Petersburg, Florida
  53. Sarasota, Florida
  54. Sarasota, Florida
  55. Spring Hill, Florida
  56. Tallahassee, Florida
  57. Tallahassee, Florida
  58. Tampa, Florida
  59. Tavares, Florida
  60. The Villages, Florida
  61. Venice, Florida
  62. Winter Park, Florida
  63. Atlanta, Georgia
  64. Atlanta, Georgia
  65. Atlanta, Georgia
  66. Atlanta, Georgia
  67. Johns Creek, Georgia
  68. Chicago, Illinois
  69. Overland Park, Kansas
  70. Baltimore, Maryland
  71. Baltimore, Maryland
  72. Baltimore, Maryland
  73. Baltimore, Maryland
  74. Boston, Massachusetts
  75. Boston, Massachusetts
  76. Boston, Massachusetts
  77. Boston, Massachusetts
  78. Boston, Massachusetts
  79. Boston, Massachusetts
  80. Chelsea, Massachusetts
  81. Stoneham, Massachusetts
  82. Stoneham, Massachusetts
  83. Creve Coeur, Missouri
  84. Independence, Missouri
  85. Kansas City, Missouri
  86. Saint Louis, Missouri
  87. Saint Louis, Missouri
  88. Saint Louis, Missouri
  89. Saint Louis, Missouri
  90. Basking Ridge, New Jersey
  91. Hackensack, New Jersey
  92. Montvale, New Jersey
  93. Bronx, New York
  94. Bronx, New York
  95. Bronx, New York
  96. New York, New York
  97. New York, New York
  98. New York, New York
  99. Durham, North Carolina
  100. Columbus, Ohio
  101. Columbus, Ohio
  102. Columbus, Ohio
  103. Columbus, Ohio
  104. Columbus, Ohio
  105. Columbus, Ohio
  106. Columbus, Ohio
  107. Gahanna, Ohio
  108. Lewis Center, Ohio
  109. Clackamas, Oregon
  110. Newberg, Oregon
  111. Portland, Oregon
  112. Portland, Oregon
  113. Pittsburgh, Pennsylvania
  114. Pittsburgh, Pennsylvania
  115. Pittsburgh, Pennsylvania
  116. Pittsburgh, Pennsylvania
  117. York, Pennsylvania
  118. Chattanooga, Tennessee
  119. Chattanooga, Tennessee
  120. Chattanooga, Tennessee
  121. Cleveland, Tennessee
  122. Dickson, Tennessee
  123. Franklin, Tennessee
  124. Gallatin, Tennessee
  125. Hendersonville, Tennessee
  126. Hermitage, Tennessee
  127. Lebanon, Tennessee
  128. Murfreesboro, Tennessee
  129. Nashville, Tennessee
  130. Nashville, Tennessee
  131. Nashville, Tennessee
  132. Nashville, Tennessee
  133. Shelbyville, Tennessee
  134. Smyrna, Tennessee
  135. Houston, Texas
  136. Houston, Texas
  137. Kingwood, Texas
  138. Shenandoah, Texas
  139. The Woodlands, Texas
  140. Seattle, Washington
  141. Faenza, Emilia-romagna
  142. Lugo, Emilia-romagna
  143. Ravenna, Emilia-romagna
  144. Ravenna, Emilia-romagna
  145. Rimini, Emilia-romagna
  146. Roma, Lazio
  147. Milano, Lombardia
  148. Napoli, Naples
  149. Cattolica, Rimini
  150. Orbassano, Torino
  151. Orbassano, Torino
  152. Orbassano, Torino
  153. Orbassano, Torino
  154. Orbassano, Torino
  155. Orbassano, Torino
  156. Orbassano, Torino
  157. Milano,
  158. Napoli,
  159. Torino,
  160. Goyang-si, Gyeonggido
  161. Jeonnam,
  162. Seoul,
  163. Seoul,
  164. Seoul,
  165. Amsterdam, Noord-holland
  166. Majadahonda, Madrid
  167. Malaga, Málaga
  168. Barcelona,
  169. Barcelona,
  170. Barcelona,
  171. Barcelona,
  172. Barcelona,
  173. Cordoba,
  174. Cordoba,
  175. Esplugues de Llobregat,
  176. Hospitalet de Llobregat,
  177. L'Hospitalet,
  178. Madrid,
  179. Madrid,
  180. Malaga,
  181. Sevilla,
  182. Sevilla,
  183. Sevilla,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Erlotinib Is Being Studied With Or Without An Investigational Drug, PF-02341066, In Patients With Lung Cancer
Official Title  ICMJE Phase 1/2, Open Label, Randomized Study Of The Safety, Efficacy, And Pharmacokinetics Of Erlotinib With Or Without Pf 02341066 In Patients With Advanced Non Small Cell Adenocarcinoma Of The Lung.
Brief Summary This is a Phase 1/2 study comparing the safety and anti-tumor activity of erlotinib alone versus erlotinib in combination with PF-02341066 in patients with advanced non-small cell lung cancer.
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 Non-Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: Erlotinib
    Erlotinib, 150 mg, QD will be administered orally on a continuous schedule (Phase 2 only)
  • Drug: Erlotinib
    For Phase 1 - escalating doses of erlotinib will be administered orally on a continuous schedule. The planned doses to be evaluated are 100 and 150 mg QD. The dose determined in Phase 1 will be used in Phase 2
  • Drug: PF-02341066
    For Phase 1 - escalating doses of PF-02341066 will be administered orally on a continuous schedule. The planned doses to be evaluated are 200 and 250 mg BID. The dose determined in Phase 1 will be used in Phase 2
Study Arms  ICMJE
  • Active Comparator: Erlotinib
    Intervention: Drug: Erlotinib
  • Experimental: Erlotinib + PF-02341066
    Interventions:
    • Drug: Erlotinib
    • Drug: PF-02341066
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
Actual Enrollment  ICMJE
 (submitted: December 7, 2012)		27
Original Estimated Enrollment  ICMJE
 (submitted: August 24, 2009)		175
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • histologically proven diagnosis of Non-Small Cell Lung Cancer (NSCLC) that is locally advanced or metastatic and of the adenocarcinoma subtype (including mixed adenosquamous histology)
  • evident disease progression by Response Evaluation Criterion in Solid Tumors (RECIST) after at least one but no more than 2 chemotherapy regimens for advanced disease
  • tumors must have measurable disease as per RECIST

Exclusion Criteria:

  • known interstitial lung disease
  • prior treatment with an agent that is known or proposed to be active by action on EGFR tyrosine kinase or c-Met/HGF (Phase 2 Portion)
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00965731
Other Study ID Numbers  ICMJE A8081002
2009-012377-35 ( EudraCT Number )
Has Data Monitoring Committee No
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 2015

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