Trial Of Erlotinib With Or Without PF-3512676 In Advanced Non Small Cell Lung Cancer

December 16, 2010 updated by: Pfizer

A Randomized Phase 2 Trial Of Erlotinib With Or Without PF-3512676 For The Treatment Of Patients With Advanced EGFR-Positive Non-Small Cell Lung Cancer After Failure Of At Least One Prior Chemotherapy Regimen

To assess the efficacy and safety of PF-3512676 administered in combination with erlotinib in patients with advanced EGFR-positive non-small cell lung cancer after failure of at least one prior chemotherapy regimen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

43

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
    • Alabama
      • Daphne, Alabama, United States, 36526
        • Pfizer Investigational Site
      • Huntsville, Alabama, United States, 35805
        • Pfizer Investigational Site
      • Mobile, Alabama, United States, 36608
        • Pfizer Investigational Site
    • California
      • Corona, California, United States, 92879
        • Pfizer Investigational Site
      • Glendora, California, United States, 91741
        • Pfizer Investigational Site
      • Greenbrae, California, United States, 94904
        • Pfizer Investigational Site
      • Pasadena, California, United States, 91105
        • Pfizer Investigational Site
      • Pomona, California, United States, 91767
        • Pfizer Investigational Site
      • Rancho Cucamonga, California, United States, 91730
        • Pfizer Investigational Site
      • San Mateo, California, United States, 94402
        • Pfizer Investigational Site
      • West Covina, California, United States, 91790
        • Pfizer Investigational Site
    • Connecticut
      • Norwalk, Connecticut, United States, 06856
        • Pfizer Investigational Site
    • Florida
      • Deerfield Beach, Florida, United States, 33442
        • Pfizer Investigational Site
      • Melbourne, Florida, United States, 32901
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33136
        • Pfizer Investigational Site
    • Indiana
      • Munster, Indiana, United States, 46321
        • Pfizer Investigational Site
    • Iowa
      • Mason City, Iowa, United States, 50401
        • Pfizer Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40202
        • Pfizer Investigational Site
    • Missouri
      • Bridgeton, Missouri, United States, 63044
        • Pfizer Investigational Site
      • Chesterfield, Missouri, United States, 63017
        • Pfizer Investigational Site
      • Kirkwood, Missouri, United States, 63122
        • Pfizer Investigational Site
    • New Jersey
      • Somerville, New Jersey, United States, 08876
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10016
        • Pfizer Investigational Site
      • Stony Brook, New York, United States, 11794
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45209
        • Pfizer Investigational Site
      • Fairfield, Ohio, United States, 45014
        • Pfizer Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-0850
        • Pfizer Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Pfizer Investigational Site
      • Philadephia, Pennsylvania, United States, 19104
        • Pfizer Investigational Site
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Pfizer Investigational Site
      • Dallas, Texas, United States, 75246
        • Pfizer Investigational Site
      • Dalls, Texas, United States, 75246
        • Pfizer Investigational Site

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:

  • Advanced, EGFR-positive NSCLC
  • ECOG Performance Status 0, 1 or 2
  • Measurable disease

Exclusion Criteria:

  • Known CNS metastasis
  • Pre-existing autoimmune or antibody mediated disease

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Standard of Care chemotherapy plus experimental intervention (PF-3512676)
Drug: PF-3512676 + Erlotinib

PF-3512676 0.2 mg/kg subcutaneously on days 1, 8 and 15 of each 21 day cycle until disease progression or unacceptable toxicity.

Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity
Active Comparator: B
Standard of Care chemotherapy
Drug: Erlotinib
Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity
Other Names:
  • Tarceva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival
Time Frame: 50Events
50Events

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: Time of death
Time of death
Overall Safety Profile
Time Frame: 28 days post treatment
28 days post treatment
Time to Tumor Progression
Time Frame: End of treatment
End of treatment
Duration of Response
Time Frame: Time of disease progression
Time of disease progression
Overall Objective Response Rate
Time Frame: Time of disease progression
Time of disease progression

Collaborators and Investigators

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

Sponsor

Pfizer

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

Helpful Links

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

August 1, 2006

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

May 3, 2006

First Submitted That Met QC Criteria

May 3, 2006

First Posted (Estimate)

May 4, 2006

Study Record Updates

Last Update Posted (Estimate)

December 23, 2010

Last Update Submitted That Met QC Criteria

December 16, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A8501006

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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