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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tragara Pharmaceuticals, Inc.
• Treatments: Erlotinib Hydrochloride

Criteria

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