- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00047840
This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Non-small Cell Lung Cancer.
August 24, 2016 updated by: Genzyme, a Sanofi Company
A Randomized, Double-blind, Multicenter, Phase II Study to Assess the Safety, Tolerability, and Efficacy of ZD6474 in Combination With Docetaxel (TAXOTERE™) in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) After Failure of Prior Platinum-based Chemotherapy.
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment
129
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
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Brno, Czech Republic
- Research Site
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Chomutov, Czech Republic
- Research Site
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Hradec, Czech Republic
- Research Site
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Ostrava, Czech Republic
- Research Site
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Plzen, Czech Republic
- Research Site
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Praha, Czech Republic
- Research Site
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Budapest, Hungary
- Research Site
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Debrecen, Hungary
- Research Site
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Deszk, Hungary
- Research Site
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Torokbalint, Hungary
- Research Site
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California
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Los Angeles, California, United States
- Research Site
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Florida
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Jacksonville, Florida, United States
- Research Site
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Georgia
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Atlanta, Georgia, United States
- Research Site
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Louisiana
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New Orleans, Louisiana, United States
- Research Site
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Massachusetts
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Boston, Massachusetts, United States
- Research Site
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Pittsfield, Massachusetts, United States
- Research Site
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Michigan
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Ann Arbor, Michigan, United States
- Research Site
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Detroit, Michigan, United States
- Research Site
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Montana
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Billings, Montana, United States
- Research Site
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New York
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Great Neck, New York, United States
- Research Site
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New York, New York, United States
- Research Site
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North Carolina
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Durham, North Carolina, United States
- Research Site
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Oregon
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Coos Bay, Oregon, United States
- Research Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States
- Research Site
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Pittsburgh, Pennsylvania, United States
- Research Site
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Texas
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Houston, Texas, United States
- Research Site
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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:
- 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
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: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Outcome Progression free survival
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Secondary Outcome Measures
Outcome Measure |
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Time to death
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Incidence and type of adverse events (Aes), clinically significant laboratory abnormalities, and ECG changes;
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Objective response rate and duration of response
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QoL and lung cancer subscale (LCS) from the FACT-L questionnaire
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WHO performance status
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
October 1, 2002
Study Completion (Actual)
September 1, 2006
Study Registration Dates
First Submitted
October 18, 2002
First Submitted That Met QC Criteria
October 23, 2002
First Posted (Estimate)
October 24, 2002
Study Record Updates
Last Update Posted (Estimate)
August 25, 2016
Last Update Submitted That Met QC Criteria
August 24, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- 6474IL/0006
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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SanofiCompleted
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