This Study is to Compare the Efficacy of ZD6474 and ZD1839 in Subjects With NSCLC. - Tabular View

Tracking Information

First Received Date ^ICMJE

May 2, 2003

Last Updated Date

April 3, 2009

Start Date ^ICMJE

April 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Primary Outcomes:
Part A
i. Time to progression
ii. Incidence, CTC grade and type of Aes, clinicallyl significant laboratory abnormalities or changes in vital signs, and ECG changes
Part B

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00059722 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Secondary Outcomes:
Part A
i. Objective response
ii. Disease control at 8 weeks
iii. Time to death
iv. WHO performance status
v. QOL and LCS from the FACT-L questionnaire
Part B
i. Objective response in subjects following treatment with the alternate study treatment
ii. Disease control at 8 weeks in subjects following treatment with the alternate study treatment
iii. WHO performance status in subjects following treatment with the alternate study treatment
iv. QOL and LCS from the FACT-L questionnaire in subjects following treatment with the alternate study treatment

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

This Study is to Compare the Efficacy of ZD6474 and ZD1839 in Subjects With NSCLC.

Official Title ^ICMJE

A Phase II, Randomized Double-Blind, 2-Part, Multicenter Study to Compare the Efficacy of ZD6474 With the Efficacy of ZD1839 (Iressa™) in Subjects With Locally Advanced or Metastatic (IIIB/IV) Non-Small Cell Lung Cancer After Failure of First-Line Platinum-Based Chemotherapy and to Assess the Activity of ZD6474 in Subjects Following Failure of Treatment With ZD1839.

Brief Summary

The purpose of this study is to compare the efficacy of ZD6474 and ZD1839 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, Dose Comparison, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Carcinoma, Non-Small-Cell Lung

Intervention ^ICMJE

Drug: ZD6474
Drug: Placebo
Drug: ZD1839

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

160

Completion Date

June 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Failure of either first-line and/or second-line chemotherapy either of which was platinum-based (the prior regimen must have failed the subject because of toxicity or progression of tumor
Prior histologic or cytologic confirmation of locally advanced or metastatic (IIIB/IV) NSCLC

Exclusion Criteria:

Subjects who have received second-line or subsequent chemotherapy
Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic, need not be excluded)

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, Argentina, Belgium, Germany, South Africa, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00059722

Responsible Party

Study ID Numbers ^ICMJE

6474IL/0003

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

AstraZeneca Oncology Medical Director, MD

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

April 2009

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