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

Tracking Information

First Received Date ^ICMJE

October 18, 2002

Last Updated Date

June 11, 2008

Start Date ^ICMJE

October 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Outcome Progression free survival

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00047840 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Same as current

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-Line

Intervention ^ICMJE

Drug: ZD6474
Drug: Placebo
Drug: Docetaxel

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

129

Completion Date

September 2006

Primary Completion Date

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Czech Republic, Hungary

Administrative Information

NCT ID ^ICMJE

NCT00047840

Responsible Party

Study ID Numbers ^ICMJE

6474IL/0006

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

ZD6474 Medical Science Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

June 2008

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