NCT00652340

APRiCOT-L: Study to Evaluate Efficacy and Safety of Apricoxib With Erlotinib in Patients With Non-small Cell Lung Cancer

APRiCOT-L (Apricoxib in Combination Oncology Treatment - Lung) A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (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 erlotinib with placebo and erlotinib as measured by time to disease progression to test the hypothesis that down regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumor will have a clinical benefit compared with erlotinib alone.

Conditions

• Recurrent Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	apricoxib/erlotinib	apricoxib: 100 mg tablets, 400mg/day erlotinib: per package insert
DRUG	erlotinib/placebo	erlotinib: per package insert placebo: 100 mg tablets, 400 mg/day

Timeline

• Start date: 2008-04-01
• Primary completion: 2010-06-01
• Completion: 2012-03-01
• First posted: 2008-04-03
• Last updated: 2012-04-09
• Results posted: 2012-04-09

Locations

47 sites across 1 country: United States