A Phase 2, Randomized, Open-Label Study Of Single Agent CI-1033 In Patients With Advanced Non-Small Cell Lung Cancer

November 6, 2006 updated by: Pfizer
The purpose of study to determine the activity of CI 1033 against tumors in patients with advanced or metastatic NSCLC who have failed prior platinum-based combination chemotherapy. Another objective is to determine the safety of CI 1033.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

163

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

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Pfizer Investigational Site
  • Germany
      • Gauting, Germany, 82131
        • Pfizer Investigational Site
      • Grosshansdorf, Germany, 22927
        • Pfizer Investigational Site
      • Heidelberg, Germany, 69126
        • Pfizer Investigational Site
  • Ireland
      • Cork, Ireland
        • Pfizer Investigational Site
      • Dublin, Ireland, 7
        • Pfizer Investigational Site
  • Italy
      • Bologna, Italy, 40139
        • Pfizer Investigational Site
      • Orbassano (Torino), Italy, 10043
        • Pfizer Investigational Site
  • Netherlands
    • NH
      • Amsterdam, NH, Netherlands, 1081 HV
        • Pfizer Investigational Site
  • Spain
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Pfizer Investigational Site
  • United Kingdom
      • Glasgow, United Kingdom, G4 0SF
        • Pfizer Investigational Site
      • London, United Kingdom, SE1 9RT
        • Pfizer Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35294
        • Pfizer Investigational Site
      • Birmingham, Alabama, United States, 35924
        • Pfizer Investigational Site
    • California
      • Greenbrae, California, United States, 94904
        • Pfizer Investigational Site
      • San Fransisco, California, United States, 94121
        • Pfizer Investigational Site
      • San Mateo, California, United States, 94402
        • Pfizer Investigational Site
      • San Pablo, California, United States, 94806
        • Pfizer Investigational Site
    • Florida
      • Tampa, Florida, United States, 33612
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Pfizer Investigational Site
      • Chicago, Illinois, United States, 60612
        • Pfizer Investigational Site
      • Park Ridge, Illinois, United States, 60068
        • Pfizer Investigational Site
      • Skokie, Illinois, United States, 60076
        • Pfizer Investigational Site
    • Indiana
      • Jefferson, Indiana, United States, 47130
        • Pfizer Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Pfizer Investigational Site
      • LaGrange, Kentucky, United States, 40031
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40202
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40217
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40207
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Pfizer Investigational Site
      • Boston, Massachusetts, United States, 02115
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Pfizer Investigational Site
      • Ann Arbor, Michigan, United States, 48106
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10032
        • Pfizer Investigational Site
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45219
        • Pfizer Investigational Site
      • Cincinnati, Ohio, United States, 45236
        • Pfizer Investigational Site
      • Columbus, Ohio, United States, 43210
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Pfizer Investigational Site
      • Nashville, Tennessee, United States, 37232
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Pfizer Investigational Site
    • Wisconsin
      • Chippewa Falls, Wisconsin, United States, 54729
        • Pfizer Investigational Site
      • Eau Claire, Wisconsin, United States, 54701
        • Pfizer Investigational Site
      • Ladysmith, Wisconsin, United States, 54848
        • Pfizer Investigational Site
      • Marshfield, Wisconsin, United States, 54449-5277
        • Pfizer Investigational Site
      • Marshfield, Wisconsin, United States, 54449
        • Pfizer Investigational Site
      • Minocqua, Wisconsin, United States, 54548
        • Pfizer Investigational Site
      • Rice Lake, Wisconsin, United States, 54868
        • Pfizer Investigational Site
      • Stevens Point, Wisconsin, United States, 54481
        • Pfizer Investigational Site
      • Wausau, Wisconsin, United States, 54401
        • Pfizer Investigational Site
      • Wisconsin Rapids, Wisconsin, United States, 54494
        • Pfizer Investigational Site
      • Woodruff, Wisconsin, United States, 54568
        • 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:

  • Histologically or cytologically documented diagnosis of progressive or recurrent, locally advanced or metastatic NSCLC; a tumor that expresses at least one member of the erbB family of receptors; failed or relapsed after receiving a platinum-containing regimen as therapy; at least one measurable target lesion as defined by RECIST that has not been irradiated.

Exclusion Criteria:

  • Prior exposure to agents that target the erbB receptor family; unknown response to prior platinum-containing chemotherapy regimen; cytotoxic chemotherapy within 3 weeks prior to baseline disease assessments (6 weeks for nitrosoureas or mitomycin); more than 2 prior chemotherapy regimens: immunotherapy or other biologic therapy within 2 weeks prior to baseline disease assessment; prior irradiation to areas encompassing greater than 30% of marrow-bearing bone; brain metastases.

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary objective is to assess the antitumor activity of CI 1033 in patients with advanced (progressive or recurrent, locally advanced [TNM Stage IIIB] or metastatic [TNM Stage IV]) NSCLC who have failed prior platinum-based combination chemotherapy

Secondary Outcome Measures

Outcome Measure
Secondary objectives also include determining the safety of CI 1033 and the detection of any correlations between baseline tumor erbB expression and efficacy. Safety will be assessed by spontaneous AE reporting, physical examinations

Collaborators and Investigators

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

Sponsor

Pfizer

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

January 1, 2003

Study Completion

November 1, 2005

Study Registration Dates

First Submitted

December 20, 2002

First Submitted That Met QC Criteria

December 23, 2002

First Posted (Estimate)

December 24, 2002

Study Record Updates

Last Update Posted (Estimate)

November 8, 2006

Last Update Submitted That Met QC Criteria

November 6, 2006

Last Verified

January 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4161003

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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