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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00047840
Recruitment Status : Completed
First Posted : October 24, 2002
Last Update Posted : August 25, 2016
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line Drug: ZD6474 Drug: Placebo Drug: Docetaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : October 2002
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Docetaxel




Primary Outcome Measures :
  1. Outcome Progression free survival

Secondary Outcome Measures :
  1. Incidence and type of adverse events (Aes), clinically significant laboratory abnormalities, and ECG changes;
  2. Objective response rate and duration of response
  3. QoL and lung cancer subscale (LCS) from the FACT-L questionnaire
  4. WHO performance status
  5. Time to death


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00047840


Locations
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United States, California
Research Site
Los Angeles, California, United States
United States, Florida
Research Site
Jacksonville, Florida, United States
United States, Georgia
Research Site
Atlanta, Georgia, United States
United States, Louisiana
Research Site
New Orleans, Louisiana, United States
United States, Massachusetts
Research Site
Boston, Massachusetts, United States
Research Site
Pittsfield, Massachusetts, United States
United States, Michigan
Research Site
Ann Arbor, Michigan, United States
Research Site
Detroit, Michigan, United States
United States, Montana
Research Site
Billings, Montana, United States
United States, New York
Research Site
Great Neck, New York, United States
Research Site
New York, New York, United States
United States, North Carolina
Research Site
Durham, North Carolina, United States
United States, Oregon
Research Site
Coos Bay, Oregon, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
Research Site
Pittsburgh, Pennsylvania, United States
United States, Texas
Research Site
Houston, Texas, United States
Czech Republic
Research Site
Brno, Czech Republic
Research Site
Chomutov, Czech Republic
Research Site
Hradec, Czech Republic
Research Site
Ostrava, Czech Republic
Research Site
Plzen, Czech Republic
Research Site
Praha, Czech Republic
Hungary
Research Site
Budapest, Hungary
Research Site
Debrecen, Hungary
Research Site
Deszk, Hungary
Research Site
Torokbalint, Hungary
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00047840    
Obsolete Identifiers: NCT00054093
Other Study ID Numbers: 6474IL/0006
First Posted: October 24, 2002    Key Record Dates
Last Update Posted: August 25, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action