This Study is to Compare the Efficacy of ZD6474 and ZD1839 in Subjects With NSCLC.

NCT ID: NCT00059722

Last Updated: 2016-08-24

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

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2007-06-30

Brief Summary

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The purpose of this study is to compare the efficacy of ZD6474 and ZD1839 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.

Detailed Description

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Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ZD6474

Intervention Type DRUG

Placebo

Intervention Type DRUG

ZD1839

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Failure of either first-line and/or second-line chemotherapy either of which was platinum-based (the prior regimen must have failed the subject because of toxicity or progression of tumor
* Prior histologic or cytologic confirmation of locally advanced or metastatic (IIIB/IV) NSCLC

Exclusion Criteria

* Subjects who have received second-line or subsequent chemotherapy
* Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic, need not be excluded)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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Research Site

Pine Bluff, Arkansas, United States

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Los Angeles, California, United States

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Palm Springs, California, United States

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San Diego, California, United States

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Boca Raton, Florida, United States

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Jacksonville, Florida, United States

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Orange Park, Florida, United States

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Coeur d'Alene, Idaho, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Shreveport, Louisiana, United States

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Saint Loius, Missouri, United States

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St Louis, Missouri, United States

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Brooklyn, New York, United States

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New York, New York, United States

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Greenville, North Carolina, United States

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Bismarck, North Dakota, United States

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Madison, Wisconsin, United States

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Buenos Aires, , Argentina

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Mendoza, , Argentina

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Brussels, , Belgium

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Brussels (Jette), , Belgium

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Brussels (Woluwé-St-Lambert), , Belgium

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Edegem, , Belgium

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Liège, , Belgium

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Wilrijk, , Belgium

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Hamburg, City state of Hamburg, Germany

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Essen, North Rhine-Westphalia, Germany

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Mainz, Rhineland-Palatinate, Germany

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Berlin, State of Berlin, Germany

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Ryhope, Sunderland, Germany

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Berlin, , Germany

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Essen, , Germany

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Hamburg, , Germany

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Mainz, , Germany

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Bloemfontein, , South Africa

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Cape Town, , South Africa

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Durban, , South Africa

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Johannesburg, , South Africa

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Lyttelton Manor, , South Africa

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Parktown, , South Africa

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Port Elizabeth, , South Africa

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Pretoria, , South Africa

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Northwood, Middlesex, United Kingdom

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Cardiff, South Glamorgan, United Kingdom

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Edinburgh, , United Kingdom

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Leeds, , United Kingdom

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Manchester, , United Kingdom

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Countries

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United States Argentina Belgium Germany South Africa United Kingdom

Other Identifiers

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6474IL/0003

Identifier Type: -

Identifier Source: org_study_id

NCT00072423

Identifier Type: -

Identifier Source: nct_alias

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