APRiCOT-L: Study to Evaluate Efficacy and Safety of Apricoxib With Erlotinib in Patients With Non-small Cell Lung Cancer
NCT ID: NCT00652340
Last Updated: 2012-04-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2008-04-30
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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A
apricoxib/erlotinib
apricoxib: 100 mg tablets, 400mg/day
erlotinib: per package insert
B
erlotinib/placebo
erlotinib: per package insert
placebo: 100 mg tablets, 400 mg/day
Interventions
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apricoxib/erlotinib
apricoxib: 100 mg tablets, 400mg/day
erlotinib: per package insert
erlotinib/placebo
erlotinib: per package insert
placebo: 100 mg tablets, 400 mg/day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Tragara Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Tracy Parrott
Role: STUDY_DIRECTOR
Tragara Pharmaceuticals, Inc.
Locations
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Tucson, Arizona, United States
Bakersfield, California, United States
Los Angeles, California, United States
Rancho Mirage, California, United States
San Diego, California, United States
San Dimas, California, United States
Stockton, California, United States
Norwich, Connecticut, United States
Lake North, Florida, United States
Lakeland, Florida, United States
Miami, Florida, United States
Savannah, Georgia, United States
Chicago, Illinois, United States
Kokomo, Indiana, United States
New Albany, Indiana, United States
Waterloo, Iowa, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
Ann Arbor, Michigan, United States
Jackson, Michigan, United States
Lansing, Michigan, United States
Livonia, Michigan, United States
Saginaw, Michigan, United States
Saint Joseph, Michigan, United States
Robbinsdale, Minnesota, United States
St Louis, Missouri, United States
Neptune City, New Jersey, United States
Elmhurst, New York, United States
Stony Brook, New York, United States
Gastonia, North Carolina, United States
Wilmington, North Carolina, United States
Akron, Ohio, United States
Canton, Ohio, United States
Columbus, Ohio, United States
Jefferson, Ohio, United States
Sylvania, Ohio, United States
Corvallis, Oregon, United States
Portland, Oregon, United States
Upland, Pennsylvania, United States
Charleston, South Carolina, United States
Arlington, Texas, United States
Galveston, Texas, United States
Newport News, Virginia, United States
Richmond, Virginia, United States
Tacoma, Washington, United States
Huntington, West Virginia, United States
Morgantown, West Virginia, United States
Countries
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References
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Gitlitz BJ, Bernstein E, Santos ES, Otterson GA, Milne G, Syto M, Burrows F, Zaknoen S. A randomized, placebo-controlled, multicenter, biomarker-selected, phase 2 study of apricoxib in combination with erlotinib in patients with advanced non-small-cell lung cancer. J Thorac Oncol. 2014 Apr;9(4):577-82. doi: 10.1097/JTO.0000000000000082.
Other Identifiers
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APRiCOT-L
Identifier Type: -
Identifier Source: secondary_id
TP2001-201
Identifier Type: -
Identifier Source: org_study_id
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