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Completed

NCT Number: NCT00652340

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

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.

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Key information

Conditions

Recurrent Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tucson, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

apricoxib/erlotinib

Drug

apricoxib: 100 mg tablets, 400mg/day

erlotinib: per package insert

erlotinib/placebo

Drug

erlotinib: per package insert

placebo: 100 mg tablets, 400 mg/day

Primary outcomes

  1. Time to Disease Progression (TDP)

    Time frame: Baseline and every other cycle.

Secondary outcomes

  1. Overall Survival

    Time frame: Randomization and every cycle

Sponsors and collaborators

Lead sponsor

Tragara Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Acronym: TP2001-201

Important dates

Study start
2008
Primary completion
2010
Study completion
2012
First posted
Apr 3, 2008
Registry last updated
Apr 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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