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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00047840
First Posted: October 24, 2002
Last Update Posted: August 25, 2016
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.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
October 18, 2002
October 24, 2002
August 25, 2016
October 2002
Not Provided
Outcome Progression free survival
Not Provided
Complete list of historical versions of study NCT00047840 on ClinicalTrials.gov Archive Site
  • Incidence and type of adverse events (Aes), clinically significant laboratory abnormalities, and ECG changes;
  • Objective response rate and duration of response
  • QoL and lung cancer subscale (LCS) from the FACT-L questionnaire
  • WHO performance status
  • Time to death
Not Provided
Not Provided
Not Provided
 
This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Non-small Cell Lung Cancer.
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line
  • Drug: ZD6474
  • Drug: Placebo
  • Drug: Docetaxel
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
129
September 2006
Not Provided

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic,   Hungary,   United States
 
 
NCT00047840
6474IL/0006
Not Provided
Not Provided
Not Provided
Sanofi ( Genzyme, a Sanofi Company )
Genzyme, a Sanofi Company
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP