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

Tracking Information
First Submitted Date ICMJE	October 18, 2002
First Posted Date ICMJE	October 24, 2002
Last Update Posted Date	August 25, 2016
Study Start Date ICMJE	October 2002
Primary Completion Date	Not Provided
Current Primary Outcome Measures ICMJE; (submitted: September 13, 2005)	Outcome Progression free survival
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00047840 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: September 13, 2005)	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
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Non-small Cell Lung Cancer.
Official Title ICMJE	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.
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.
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
Condition ICMJE	Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line
Intervention ICMJE	Drug: ZD6474; Drug: Placebo; Drug: Docetaxel
Study Arms	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Enrollment ICMJE; (submitted: June 23, 2005)	129
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	September 2006
Primary Completion Date	Not Provided
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Czech Republic, Hungary, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00047840
Other Study ID Numbers ICMJE	6474IL/0006
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Sanofi ( Genzyme, a Sanofi Company )
Study Sponsor ICMJE	Genzyme, a Sanofi Company
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Clinical Sciences & Operations Sanofi
PRS Account	Sanofi
Verification Date	August 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP