Status:
COMPLETED
Study Of Gemcitabine Plus AG-013736 Versus Gemcitabine For Advanced Pancreatic Cancer.
Lead Sponsor:
Pfizer
Conditions:
Carcinoma, Pancreatic Ductal
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT00471146
Start Date
July 1 2007
End Date
November 1 2010
Last Update
July 16 2012
Active Locations (204)
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1
Pfizer Investigational Site
Antioch, California, United States, 94531
2
Pfizer Investigational Site
Corona, California, United States, 92878
3
Pfizer Investigational Site
Glendora, California, United States, 91741
4
Pfizer Investigational Site
La Jolla, California, United States, 92037