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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00652340
First Posted: April 3, 2008
Last Update Posted: April 9, 2012
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.
Information provided by (Responsible Party):
Tragara Pharmaceuticals, Inc.
  Purpose
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 Intervention Phase
Recurrent Non Small Cell Lung Cancer Drug: apricoxib/erlotinib Drug: erlotinib/placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Tragara Pharmaceuticals, Inc.:

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 ]

Enrollment: 120
Study Start Date: April 2008
Study Completion Date: March 2012
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


  Show 47 Study Locations
Sponsors and Collaborators
Tragara Pharmaceuticals, Inc.
Investigators
Study Director: Tracy Parrott Tragara Pharmaceuticals, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tragara Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00652340     History of Changes
Other Study ID Numbers: TP2001-201
APRiCOT-L
First Submitted: March 31, 2008
First Posted: April 3, 2008
Results First Submitted: March 13, 2012
Results First Posted: April 9, 2012
Last Update Posted: April 9, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
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