This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Non-small Cell Lung Cancer.

NCT ID: NCT00047840

Last Updated: 2016-08-25

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

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2006-09-30

Brief Summary

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

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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ZD6474

Intervention Type DRUG

Placebo

Intervention Type DRUG

Docetaxel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologic or cytologic confirmation of NSCLC (locally advanced or metastatic, IB-IV)
* Failure of first-line platinum-based chemotherapy

Exclusion Criteria

* Mixed small cell or non-small-cell histology
* Bronchoalveolar carcinoma
* Prior chemotherapy or herbal preparations must be discontinued more than 4 weeks before the start of study therapy (6 weeks for nitrosoureas, mitomycin and suramin)
* Prior treatment with docetaxel
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

Los Angeles, California, United States

Site Status

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Jacksonville, Florida, United States

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Atlanta, Georgia, United States

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New Orleans, Louisiana, United States

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Boston, Massachusetts, United States

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Pittsfield, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Billings, Montana, United States

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Great Neck, New York, 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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Coos Bay, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Houston, Texas, United States

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Brno, , Czechia

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Chomutov, , Czechia

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Hradec, , Czechia

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Ostrava, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Budapest, , Hungary

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Debrecen, , Hungary

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Deszk, , Hungary

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Törökbálint, , Hungary

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Countries

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United States Czechia Hungary

Other Identifiers

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6474IL/0006

Identifier Type: -

Identifier Source: org_study_id

NCT00054093

Identifier Type: -

Identifier Source: nct_alias

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