APRiCOT-L: Study to Evaluate Efficacy and Safety of Apricoxib With Erlotinib in Patients With Non-small Cell Lung Cancer
TP2001-201
APRiCOT-L (Apricoxib in Combination Oncology Treatment - Lung) A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase 2 Study of the Efficacy and Safety of Apricoxib in Combination With Erlotinib in Non-Small Cell Lung Cancer Patients
2 other identifiers
interventional
120
1 country
47
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2008
Typical duration for phase_2
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2008
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedFirst Posted
Study publicly available on registry
April 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedResults Posted
Study results publicly available
April 9, 2012
CompletedApril 9, 2012
March 1, 2012
2.2 years
March 31, 2008
March 13, 2012
March 13, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Disease Progression (TDP)
Baseline and every other cycle.
Secondary Outcomes (1)
Overall Survival
Randomization and every cycle
Study Arms (2)
A
EXPERIMENTALB
PLACEBO COMPARATORInterventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Bakersfield, California, United States
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Los Angeles, California, United States
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Rancho Mirage, California, United States
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San Diego, California, United States
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San Dimas, California, United States
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Stockton, California, United States
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Norwich, Connecticut, United States
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Lake North, Florida, United States
Unknown Facility
Lakeland, Florida, United States
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Miami, Florida, United States
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Savannah, Georgia, United States
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Chicago, Illinois, United States
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Kokomo, Indiana, United States
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New Albany, Indiana, United States
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Waterloo, Iowa, United States
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Louisville, Kentucky, United States
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New Orleans, Louisiana, United States
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Ann Arbor, Michigan, United States
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Jackson, Michigan, United States
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Lansing, Michigan, United States
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Livonia, Michigan, United States
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Saginaw, Michigan, United States
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Saint Joseph, Michigan, United States
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Robbinsdale, Minnesota, United States
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St Louis, Missouri, United States
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Neptune City, New Jersey, United States
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Elmhurst, New York, United States
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Stony Brook, New York, United States
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Gastonia, North Carolina, United States
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Wilmington, North Carolina, United States
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Akron, Ohio, United States
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Canton, Ohio, United States
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Columbus, Ohio, United States
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Jefferson, Ohio, United States
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Sylvania, Ohio, United States
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Corvallis, Oregon, United States
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Portland, Oregon, United States
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Upland, Pennsylvania, United States
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Charleston, South Carolina, United States
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Arlington, Texas, United States
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Galveston, Texas, United States
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Newport News, Virginia, United States
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Richmond, Virginia, United States
Unknown Facility
Tacoma, Washington, United States
Unknown Facility
Huntington, West Virginia, United States
Unknown Facility
Morgantown, West Virginia, United States
Related Publications (1)
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.
PMID: 24736085DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Tracy Parrott
- Organization
- Tragara Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Tracy Parrott
Tragara Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2008
First Posted
April 3, 2008
Study Start
April 1, 2008
Primary Completion
June 1, 2010
Study Completion
March 1, 2012
Last Updated
April 9, 2012
Results First Posted
April 9, 2012
Record last verified: 2012-03