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AG-013736 In Combination With Gemcitabine Versus Gemcitabine Alone For Patients With Metastatic Pancreatic Cancer

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NCT00219557

Last updated on October 5, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Antioch, California, 94509 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pancreatic Neoplasms
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

- patients with advanced (localized but surgically unresectable or metastatic)
histologically/cytologically proven epithelial cancer of the exocrine pancreas

- no prior therapy for metastatic disease

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

- patients with locally advanced disease who are candidates for radiation therapy.

- uncontrolled brain metastases (a controlled brain metastasis must be previously
treated, asymptomatic, and without growth for 4 months)

NCT00219557
Pfizer
Completed
AG-013736 In Combination With Gemcitabine Versus Gemcitabine Alone For Patients With Metastatic Pancreatic Cancer

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AG-013736 In Combination With Gemcitabine Versus Gemcitabine Alone For Patients With Metastatic Pancreatic Cancer
A Randomized Phase 2 Study Of The Anti-Angiogenesis Agent AG-013736 In Combination With Gemcitabine In Patients With Chemotherapy Naive Advanced Pancreatic Cancer Preceded By A Phase 1 Portion
This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that is locally advanced or that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior systemic treatment for advanced disease. The purpose of the study is to test whether the angiogenesis inhibitor Axitinib [AG-013736] in combination with gemcitabine is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall survival.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pancreatic Neoplasms
  • Drug: Gemcitabine
    Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks
  • Drug: AG-013736
    Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks.
  • Drug: Gemcitabine
    Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
  • Active Comparator: Gemcitabine
    Intervention: Drug: Gemcitabine
  • Experimental: Axitinib [AG-013736] plus gemcitabine
    Interventions:
    • Drug: AG-013736
    • Drug: Gemcitabine
Spano JP, Chodkiewicz C, Maurel J, Wong R, Wasan H, Barone C, Létourneau R, Bajetta E, Pithavala Y, Bycott P, Trask P, Liau K, Ricart AD, Kim S, Rixe O. Efficacy of gemcitabine plus axitinib compared with gemcitabine alone in patients with advanced pancreatic cancer: an open-label randomised phase II study. Lancet. 2008 Jun 21;371(9630):2101-8. doi: 10.1016/S0140-6736(08)60661-3. Epub 2008 May 29.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
March 2008
March 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with advanced (localized but surgically unresectable or metastatic) histologically/cytologically proven epithelial cancer of the exocrine pancreas
  • no prior therapy for metastatic disease

Exclusion Criteria:

  • patients with locally advanced disease who are candidates for radiation therapy.
  • uncontrolled brain metastases (a controlled brain metastasis must be previously treated, asymptomatic, and without growth for 4 months)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   France,   Germany,   Italy,   Spain,   United Kingdom,   United States
 
 
NCT00219557
A4061016
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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