Status:
COMPLETED
APRiCOT-P: Study of Apricoxib With Gemcitabine and Erlotinib to Treat Advanced Pancreatic Cancer
Lead Sponsor:
Tragara Pharmaceuticals, Inc.
Conditions:
Pancreatic Cancer
Metastatic Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib in patients with advanced pancreatic cancer.
Detailed Description
This study will compare the anti-tumor efficacy of apricoxib and gemcitabine/erlotinib with placebo and gemcitabine/erlotinib as measured by progression-free survival to test the hypothesis that down ...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed adenocarcinoma of the pancreas that is locally advanced or metastatic.
- Life expectancy greater than or equal to 3 months.
- Patients must have measurable disease by RECIST.
- ECOG PS of 0, 1, or 2.
- Negative serum pregnancy test at the time of first dose for women of childbearing potential.
Exclusion
- Previous chemotherapy as primary treatment for locally advanced or metastatic pancreatic cancer(stage 3 T3 and T4, and all stage 4).
- RT within 2 weeks or chemotherapy within 3 weeks or noncytotoxic investigational agents within 4 weeks of initiating study treatment.
- Evidence of New York Heart Association class III or greater cardiac disease.
- History of myocardial infarction, stroke, ventricular arrhythmia.
- Symptomatic central nervous system metastases.
- Pregnant or nursing women.
- Hypersensitivity or intolerance to apricoxib, erlotinib, gemcitabine, sulfonamides, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs).
- History of upper gastrointestinal bleeding, ulceration or perforation. History of lower GI bleeding, ulceration, or perforation within 12 months.
- Previous anti-EGFR kinase therapy.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00709826
Start Date
August 1 2008
End Date
May 1 2011
Last Update
November 7 2012
Active Locations (39)
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1
Arizona Clinical Research Center
Tucson, Arizona, United States, 85715
2
Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
3
Southbay Oncology Hematology Partners
Campbell, California, United States, 95008
4
Bay Area Cancer Research Group, LLC
Concord, California, United States, 94523