APRiCOT-L: Study to Evaluate Efficacy and Safety of Apricoxib With Erlotinib in Patients With Non-small Cell Lung Cancer (TP2001-201)
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| ClinicalTrials.gov Identifier: NCT00652340 |
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Recruitment Status :
Completed
First Posted : April 3, 2008
Results First Posted : April 9, 2012
Last Update Posted : April 9, 2012
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Sponsor:
Tragara Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Tragara Pharmaceuticals, Inc.
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Recurrent Non Small Cell Lung Cancer | Drug: apricoxib/erlotinib Drug: erlotinib/placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | April 2008 |
| Actual Primary Completion Date : | June 2010 |
| Actual Study Completion Date : | March 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
MedlinePlus related topics:
Lung Cancer
| Arm | Intervention/treatment |
|---|---|
| Experimental: A |
Drug: apricoxib/erlotinib
apricoxib: 100 mg tablets, 400mg/day erlotinib: per package insert |
| Placebo Comparator: B |
Drug: erlotinib/placebo
erlotinib: per package insert placebo: 100 mg tablets, 400 mg/day |
Primary Outcome Measures :
- Time to Disease Progression (TDP) [ Time Frame: Baseline and every other cycle. ]
Secondary Outcome Measures :
- Overall Survival [ Time Frame: Randomization and every cycle ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652340
Locations
| United States, Arizona | |
| Tucson, Arizona, United States | |
| United States, California | |
| 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 | |
| United States, Connecticut | |
| Norwich, Connecticut, United States | |
| United States, Florida | |
| Lake North, Florida, United States | |
| Lakeland, Florida, United States | |
| Miami, Florida, United States | |
| United States, Georgia | |
| Savannah, Georgia, United States | |
| United States, Illinois | |
| Chicago, Illinois, United States | |
| United States, Indiana | |
| Kokomo, Indiana, United States | |
| New Albany, Indiana, United States | |
| United States, Iowa | |
| Waterloo, Iowa, United States | |
| United States, Kentucky | |
| Louisville, Kentucky, United States | |
| United States, Louisiana | |
| New Orleans, Louisiana, United States | |
| United States, Michigan | |
| Ann Arbor, Michigan, United States | |
| Jackson, Michigan, United States | |
| Lansing, Michigan, United States | |
| Livonia, Michigan, United States | |
| Saginaw, Michigan, United States | |
| St. Joseph, Michigan, United States | |
| United States, Minnesota | |
| Robbinsdale, Minnesota, United States | |
| United States, Missouri | |
| St. Louis, Missouri, United States | |
| United States, New Jersey | |
| Neptune, New Jersey, United States | |
| United States, New York | |
| Elmhurst, New York, United States | |
| Stony Brook, New York, United States | |
| United States, North Carolina | |
| Gastonia, North Carolina, United States | |
| Wilmington, North Carolina, United States | |
| United States, Ohio | |
| Akron, Ohio, United States | |
| Canton, Ohio, United States | |
| Columbus, Ohio, United States | |
| Jefferson City, Ohio, United States | |
| Sylvania, Ohio, United States | |
| United States, Oregon | |
| Corvallis, Oregon, United States | |
| Portland, Oregon, United States | |
| United States, Pennsylvania | |
| Upland, Pennsylvania, United States | |
| United States, South Carolina | |
| Charleston, South Carolina, United States | |
| United States, Texas | |
| Arlington, Texas, United States | |
| Galveston, Texas, United States | |
| United States, Virginia | |
| Newport News, Virginia, United States | |
| Richmond, Virginia, United States | |
| United States, Washington | |
| Tacoma, Washington, United States | |
| United States, West Virginia | |
| Huntington, West Virginia, United States | |
| Morgantown, West Virginia, United States | |
Sponsors and Collaborators
Tragara Pharmaceuticals, Inc.
Investigators
| Study Director: | Tracy Parrott | Tragara Pharmaceuticals, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Tragara Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00652340 |
| Other Study ID Numbers: |
TP2001-201 APRiCOT-L |
| First Posted: | April 3, 2008 Key Record Dates |
| Results First Posted: | April 9, 2012 |
| Last Update Posted: | April 9, 2012 |
| Last Verified: | March 2012 |
Additional relevant MeSH terms:
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Carcinoma, Bronchogenic Bronchial Neoplasms Erlotinib Hydrochloride Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |