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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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00047840
First received: October 18, 2002
Last updated: January 3, 2013
Last verified: January 2013

October 18, 2002
January 3, 2013
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic,   Hungary
 
NCT00047840
6474IL/0006
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: ZD6474 Medical Science Director, MD AstraZeneca
AstraZeneca
January 2013

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