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 (Responsible Party):

Sanofi ( Genzyme, a Sanofi Company )

ClinicalTrials.gov Identifier:

NCT00047840

First received: October 18, 2002

Last updated: August 24, 2016

Last verified: August 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

October 18, 2002

Last Updated Date

August 24, 2016

Start Date ^ICMJE

October 2002

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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 Arm (s)

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

129

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

Gender

Both

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States, Czech Republic, Hungary

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00047840

Other Study ID Numbers ^ICMJE

6474IL/0006

Has Data Monitoring Committee

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Genzyme, a Sanofi Company

Study Sponsor ^ICMJE

Genzyme, a Sanofi Company

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Sciences & Operations

Sanofi

Information Provided By

Sanofi

Verification Date

August 2016

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

To Top