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APRiCOT-L: Study to Evaluate Efficacy and Safety of Apricoxib With Erlotinib in Patients With Non-small Cell Lung Cancer (TP2001-201)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00652340
Recruitment Status : Completed
First Posted : April 3, 2008
Results First Posted : April 9, 2012
Last Update Posted : April 9, 2012
Sponsor:
Information provided by (Responsible Party):
Tragara Pharmaceuticals, Inc.

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

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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


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 :
  1. Time to Disease Progression (TDP) [ Time Frame: Baseline and every other cycle. ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Randomization and every cycle ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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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
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Study Director: Tracy Parrott Tragara Pharmaceuticals, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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