Status:
COMPLETED
APRiCOT-L: Study to Evaluate Efficacy and Safety of Apricoxib With Erlotinib in Patients With Non-small Cell Lung Cancer
Lead Sponsor:
Tragara Pharmaceuticals, Inc.
Conditions:
Recurrent Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00652340
Start Date
April 1 2008
End Date
March 1 2012
Last Update
April 9 2012
Active Locations (47)
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1
Tucson, Arizona, United States
2
Bakersfield, California, United States
3
Los Angeles, California, United States
4
Rancho Mirage, California, United States