NCT00709826

APRiCOT-P: Study of Apricoxib With Gemcitabine and Erlotinib to Treat Advanced Pancreatic Cancer

APRiCOT-P (Apricoxib in Combination Oncology Treatment - Pancreas): Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Gemcitabine and Erlotinib in the Treatment of Patients With Advanced Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Tragara Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumors will have a clinical benefit compared with Gemcitabine/Erlotinib only.

Conditions

• Pancreatic Cancer
• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine	Gemcitabine: per package insert.
DRUG	placebo	placebo: 100 mg tablets, 400 mg/day
DRUG	Erlotinib	Erlotinib - per package insert.
DRUG	apricoxib	apricoxib: 100mg tablets, given orally

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-06-01
• Completion: 2011-05-01
• First posted: 2008-07-03
• Last updated: 2012-11-07
• Results posted: 2012-11-07

Locations

39 sites across 1 country: United States