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

Completed · Phase 2 · Has a placebo group

Conditions studied: Recurrent Non Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT00652340

Run by

Tragara Pharmaceuticals, Inc.

People needed

120

Starts

2008-04-01

Expected to finish

2012-03-01

Last updated by the study team

2012-04-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Bakersfield, California, United States
• Study site — Los Angeles, California, United States
• Study site — Rancho Mirage, California, United States
• Study site — San Diego, California, United States
• Study site — San Dimas, California, United States
• Study site — Stockton, California, United States
• Study site — Norwich, Connecticut, United States
• Study site — Lake North, Florida, United States
• Study site — Lakeland, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Savannah, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Kokomo, Indiana, United States
• Study site — New Albany, Indiana, United States
• Study site — Waterloo, Iowa, United States
• Study site — Louisville, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Jackson, Michigan, United States
• Study site — Lansing, Michigan, United States
• Study site — Livonia, Michigan, United States
• Study site — Saginaw, Michigan, United States
• Study site — Saint Joseph, Michigan, United States
• Study site — Robbinsdale, Minnesota, United States

Full record on ClinicalTrials.gov

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