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

Phase 2

Completed

• Conditions: Recurrent Non Small Cell Lung Cancer
• Interventions: Drug: apricoxib/erlotinib; Drug: erlotinib/placebo

• Registration Number: NCT00652340
• Lead Sponsor: Tragara Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-31
• Study Start: 2008-04
• Study First Submitted QC: 2008-04-02
• Study First Posted: 2008-04-03
• Primary Completion: 2010-06
• Status Verified: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2012-03-13
• Results First Submitted QC: 2012-03-13
• Last Update Submitted: 2012-03-13
• Results First Posted: 2012-04-09
• Last Update Posted: 2012-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Pathologically determined Stage IV NSCLC including Stage IIIb (pleural effusion)
• Failed at least one prior platinum-based chemotherapy for Stage IIIb or Stage IV NSCLC. Patients receiving platinum-based chemotherapy only given in an adjuvant setting are not eligible.
• Measurable disease by RECIST
• Greater than or equal to 18 years of age
• ECOG PS of 0 or 1

Exclusion Criteria

• Radiation therapy within 2 weeks; chemotherapy within 3 weeks; non-cytotoxic investigational agents within 4 weeks of initiating study treatment
• Evidence of NYHA class III or greater cardiac disease
• History of MI, stroke, ventricular arrhythmia, or symptomatic conduction abnormality within 12 months
• Known HIV infection or AIDS
• Symptomatic CNS metastases
• Pregnant or nursing women
• Hypersensitivity or intolerance to erlotinib, sulfonamides, aspirin, or other NSAIDs.
• History of upper GI bleeding, ulceration, or perforation
• Prior history of COX-2 inhibitor therapy for the treatment of metastatic NSCLC
• Previous anti-EGFR kinase therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	apricoxib/erlotinib	-
B	erlotinib/placebo	-

Primary Outcome Measures

Name	Time	Method
Time to Disease Progression (TDP)	Baseline and every other cycle.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Randomization and every cycle