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

NCT ID: NCT00050830

Last Updated: 2006-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

163 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Lung Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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CI 1033

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

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Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Greenbrae, California, United States

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San Francisco, California, United States

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San Mateo, California, United States

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San Pablo, California, United States

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Tampa, Florida, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Park Ridge, Illinois, United States

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Skokie, Illinois, United States

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Jefferson, Indiana, United States

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Crestview Hills, Kentucky, United States

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La Grange, Kentucky, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Ann Arbor, Michigan, United States

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New York, New York, United States

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Durham, North Carolina, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Houston, Texas, United States

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Salt Lake City, Utah, United States

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Chippewa Falls, Wisconsin, United States

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Eau Claire, Wisconsin, United States

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Ladysmith, Wisconsin, United States

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Marshfield, Wisconsin, United States

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Marshfield, Wisconsin, United States

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Minocqua, Wisconsin, United States

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Rice Lake, Wisconsin, United States

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Stevens Point, Wisconsin, United States

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Wausau, Wisconsin, United States

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Wisconsin Rapids, Wisconsin, United States

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Woodruff, Wisconsin, United States

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Edmonton, Alberta, Canada

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Montreal, Quebec, Canada

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Gauting, , Germany

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Großhansdorf, , Germany

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Heidelberg, , Germany

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Cork, , Ireland

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Dublin, , Ireland

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Bologna, , Italy

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Orbassano (Torino), , Italy

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Amsterdam, North Holland, Netherlands

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L'Hospitalet de Llobregat, Barcelona, Spain

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Glasgow, , United Kingdom

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London, , United Kingdom

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Countries

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United States Canada Germany Ireland Italy Netherlands Spain United Kingdom

Other Identifiers

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A4161003

Identifier Type: -

Identifier Source: org_study_id