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

NCT00652340 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2012-04-09

Study results available
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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.

Conditions

  • Recurrent Non Small Cell Lung Cancer

Interventions

DRUG

apricoxib/erlotinib

apricoxib: 100 mg tablets, 400mg/day erlotinib: per package insert

DRUG

erlotinib/placebo

erlotinib: per package insert placebo: 100 mg tablets, 400 mg/day

Sponsors & Collaborators

  • Tragara Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Tracy Parrott · Tragara Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2010-06-30
Completion
2012-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00652340 on ClinicalTrials.gov