Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.

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NCT00471146

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Study Location
Pfizer Investigational Site
Antioch, California, 94531, 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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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pancreatic Ductal 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 confirmed, metastatic or locally-, advanced pancreatic adenocarcinoma not amenable to curative resection.

- Adequate renal, hepatic and bone marrow function.

- Performance status 0 or 1.

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


- Prior treatment with any systemic chemotherapy for metastatic disease.


- Prior treatment with gemcitabine, AG-013736, or other vascular endothelial growth
factor inhibitors.


- Current or recent bleeding, thromboembolic event and or use of a thrombolytic agent.


- Inability to take oral medication.

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Pancreatic Ductal CarcinomaStudy Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer. NCT00471146
  1. Antioch, California
  2. Corona, California
  3. Glendora, California
  4. La Jolla, California
  5. La Jolla, California
  6. LaVerne, California
  7. Pamona, California
  8. Pasadena, California
  9. Pleasent Hill, California
  10. Pomona, California
  11. Rancho Cucamonga, California
  12. Rancho Mirage, California
  13. Redlands, California
  14. San Diego, California
  15. San Diego, California
  16. San Leandro, California
  17. West Covina, California
  18. Hollywood, Florida
  19. Pembroke Pines, Florida
  20. Stuart, Florida
  21. Tampa, Florida
  22. Atlanta, Georgia
  23. Augusta, Georgia
  24. Augusta, Georgia
  25. Coeur D'Alene, Idaho
  26. Alton, Illinois
  27. Chicago, Illinois
  28. Beech Grove, Indiana
  29. Indianapolis, Indiana
  30. Indianapolis, Indiana
  31. Jeffersonville, Indiana
  32. Louisville, Kentucky
  33. Louisville, Kentucky
  34. Louisville, Kentucky
  35. Louisville, Kentucky
  36. Shelbyville, Kentucky
  37. Baton Rouge, Louisiana
  38. Baton Rouge, Louisiana
  39. Annapolis, Maryland
  40. Burlington, Massachusetts
  41. Peabody, Massachusetts
  42. Kalamazoo, Michigan
  43. Columbus, Mississippi
  44. Corinth, Mississippi
  45. Southaven, Mississippi
  46. Tupelo, Mississippi
  47. St. Louis, Missouri
  48. Billings, Montana
  49. Lincoln, Nebraska
  50. Las Vegas, Nevada
  51. Mineola, New York
  52. Syracuse, New York
  53. Canton, Ohio
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  55. Sylvania, Ohio
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  72. Everett, Washington
  73. Federal Way, Washington
  74. Kennewick, Washington
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  76. Puyallup, Washington
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  78. Bahia Blanca, Buenos Aires
  79. La Plata, Buenos Aires
  80. Ciudad Autonoma de Buenos Aires,
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  83. Wollongong, New South Wales
  84. Clayton, Victoria
  85. East Bentleigh, Victoria
  86. Salzburg,
  87. Wels,
  88. Wien,
  89. Wien,
  90. Wien,
  91. Brussel,
  92. Bruxelles,
  93. Bruxelles,
  94. Gent,
  95. Leuven,
  96. Wilrijk,
  97. Edmonton, Alberta
  98. Kelowna, British Columbia
  99. Victoria, British Columbia
  100. Winnipeg, Manitoba
  101. Winnipeg, Manitoba
  102. Moncton, New Brunswick
  103. Kingston, Ontario
  104. Kingston, Ontario
  105. Oshawa, Ontario
  106. Toronto, Ontario
  107. Montreal, Quebec
  108. Montreal, Quebec
  109. Montreal, Quebec
  110. Clichy cedex,
  111. La Chaussee Saint Victor,
  112. Marseille,
  113. Montpellier Cedex 02,
  114. PARIS Cedex 13,
  115. Paris,
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  128. Shatin, NT
  129. Budapest,
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  132. Kaposvar,
  133. Szentes,
  134. Zalaegerszeg,
  135. Ahmedabad, Gujarat
  136. Bangalore, Karnataka
  137. Cochin, Kerala
  138. Andhra, Pradesh
  139. Chennai, Tamil Nadu
  140. Dublin 24,
  141. Dublin,
  142. Bologna,
  143. Catania,
  144. Milano,
  145. Milano,
  146. Padova,
  147. Verona,
  148. Nagoya, Aichi
  149. Chiba-shi, Chiba-ken
  150. Chiba city, Chiba
  151. Kashiwa-shi, Chiba
  152. Fukuoka-shi, Fukuoka-ken
  153. Yokohama-shi, Kanagawa
  154. Osaka-shi, Osaka-fu
  155. Suntougun, Shizuoka
  156. Chuo-ku, Tokyo
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  184. Madrid,
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  187. Toledo,
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  190. Winterthur,
  191. Kuei-Shan Jsoamg, Taoyuan County
  192. Taichung,
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  194. Whitchurch, Cardiff
  195. Maidstone, Kent
  196. Leicester, Leicestershire
  197. Withington, Manchester
  198. Northwood, Middlesex
  199. Birmingham,
  200. Birmingham,
  201. Edinburgh,
  202. London,
  203. London,
  204. Manchester,
  205. Southhampton,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.
Official Title  ICMJE A Randomized, Double-Blind Phase 3 Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine Plus Placebo For The First-Line Treatment Of Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer.
Brief Summary The purpose of this study is to determine whether investigational study drug, AG-013736, and gemcitabine are effective in the first-line treatment of advanced pancreatic cancer.
Detailed Description This study was prematurely discontinued for futility on 23 January 2009, based on a planned interim analysis by an independent Data Safety Monitoring Board (DSMB) that found no evidence of improvement in the primary endpoint (survival) in patients treated with axitinib and gemcitabine compared to gemcitabine alone. Enrollment on this study has been discontinued.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Pancreatic Ductal
Intervention  ICMJE
  • Drug: AG-013736
    oral administration, starting dose 5 mg twice daily [BID] every day until unacceptable toxicity or tumor progression.
  • Drug: Gemcitabine
    intravenous administration at 1,000 mg/m^2 day 1, day 8 and day 15 every 4 weeks (conventional dose) until unacceptable toxicity or tumor progression.
  • Drug: placebo
    placebo
Study Arms  ICMJE
  • Experimental: A
    Interventions:
    • Drug: AG-013736
    • Drug: Gemcitabine
  • Active Comparator: B
    Interventions:
    • Drug: Gemcitabine
    • Drug: placebo
Publications * Kindler HL, Ioka T, Richel DJ, Bennouna J, Létourneau R, Okusaka T, Funakoshi A, Furuse J, Park YS, Ohkawa S, Springett GM, Wasan HS, Trask PC, Bycott P, Ricart AD, Kim S, Van Cutsem E. Axitinib plus gemcitabine versus placebo plus gemcitabine in patients with advanced pancreatic adenocarcinoma: a double-blind randomised phase 3 study. Lancet Oncol. 2011 Mar;12(3):256-62. doi: 10.1016/S1470-2045(11)70004-3.

*   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 1, 2011)		630
Original Enrollment  ICMJE
 (submitted: May 7, 2007)		596
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed, metastatic or locally-, advanced pancreatic adenocarcinoma not amenable to curative resection.
  • Adequate renal, hepatic and bone marrow function.
  • Performance status 0 or 1.

Exclusion Criteria:

  • Prior treatment with any systemic chemotherapy for metastatic disease.
  • Prior treatment with gemcitabine, AG-013736, or other vascular endothelial growth factor inhibitors.
  • Current or recent bleeding, thromboembolic event and or use of a thrombolytic agent.
  • Inability to take oral medication.
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,   Belgium,   Canada,   France,   Germany,   Hong Kong,   Hungary,   India,   Ireland,   Italy,   Japan,   Korea, Republic of,   Netherlands,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries Portugal
 
Administrative Information
NCT Number  ICMJE NCT00471146
Other Study ID Numbers  ICMJE A4061028
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 June 2012

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