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

March 13, 2012 updated by: Tragara Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, 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
    • Connecticut
      • Norwich, Connecticut, United States
    • Florida
      • Lake North, Florida, United States
      • Lakeland, Florida, United States
      • Miami, Florida, United States
    • Georgia
      • Savannah, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Kokomo, Indiana, United States
      • New Albany, Indiana, United States
    • Iowa
      • Waterloo, Iowa, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Louisiana
      • New Orleans, Louisiana, 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
    • Minnesota
      • Robbinsdale, Minnesota, United States
    • Missouri
      • St. Louis, Missouri, United States
    • New Jersey
      • Neptune, New Jersey, United States
    • New York
      • Elmhurst, New York, United States
      • Stony Brook, New York, United States
    • North Carolina
      • Gastonia, North Carolina, United States
      • Wilmington, North Carolina, United States
    • Ohio
      • Akron, Ohio, United States
      • Canton, Ohio, United States
      • Columbus, Ohio, United States
      • Jefferson City, Ohio, United States
      • Sylvania, Ohio, United States
    • Oregon
      • Corvallis, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Upland, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
    • Texas
      • Arlington, Texas, United States
      • Galveston, Texas, United States
    • Virginia
      • Newport News, Virginia, United States
      • Richmond, Virginia, United States
    • Washington
      • Tacoma, Washington, United States
    • West Virginia
      • Huntington, West Virginia, United States
      • Morgantown, West Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to Disease Progression (TDP)
Time Frame: Baseline and every other cycle.
Baseline and every other cycle.

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: Randomization and every cycle
Randomization and every cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tragara Pharmaceuticals, Inc.

Investigators

  • Study Director: Tracy Parrott, Tragara Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

March 31, 2008

First Submitted That Met QC Criteria

April 2, 2008

First Posted (Estimate)

April 3, 2008

Study Record Updates

Last Update Posted (Estimate)

April 9, 2012

Last Update Submitted That Met QC Criteria

March 13, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TP2001-201
  • APRiCOT-L

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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