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:
Information provided by (Responsible Party):
Tragara Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00652340
First received: March 31, 2008
Last updated: March 13, 2012
Last verified: March 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival [ Time Frame: Randomization and every cycle ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652340

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

No publications provided by Tragara Pharmaceuticals, Inc.

Additional 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
Study First Received: March 31, 2008
Results First Received: March 13, 2012
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014