Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 19, 2005

Last Updated Date

April 22, 2009

Start Date ^†

July 2003

Current Primary Outcome Measures ^†

The primary objective of this study is to compare overall survival for ZD1839 plus best supportive care versus placebo plus best supportive care

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00242801 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

· ZD1839 + BSC versus Placebo + BSC in terms of time to treatment failure
· ZD1839 + BSC versus Placebo + BSC in terms of investigator assessed overall
· objective tumour response (CR + PR)
· ZD1839 + BSC versus Placebo + BSC in terms of tolerability
· ZD1839 + BSC versus Placebo + BSC in terms of quality of life changes

Original Secondary Outcome Measures ^†

· ZD1839 + BSC versus Placebo + BSC in terms of time to treatment failure
· ZD1839 + BSC versus Placebo + BSC in terms of investigator assessed overall
· objective tumour response (CR + PR)
· ZD1839 + BSC versus Placebo + BSC in terms of tolerability
· ZD1839 + BSC versus Placebo + BSC in terms of quality of life changes

Descriptive Information

Brief Title ^†

Iressa vs Best Supportive Care - 2nd/3rd Line Survival Study

Official Title ^†

A Double Blind,Placebo Controlled,Parallel Group,Multicentre,Randomised,Phase Iii Survival Study Comparing ZD1839 (IRESSA™)(250mg Tablet) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care In Patients With Advanced NSCLC Who Have Received One Or Two Prior Chemotherapy Regimens And Are Refractory Or Intolerant To Their Most Recent Regimen

Brief Summary

This study is being carried out to see if adding ZD1839 to other standard supportive care is more effective than standard supportive care alone for the treatment of patients with NSCLC whose disease has recurred after previous chemotherapy treatment.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

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

Condition ^†

NSCLC

Intervention ^†

Drug: Gefitinib

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 ^†

Completed

Enrollment ^†

1692

Completion Date

April 2005

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

· Life expectancy of at least 8 weeks.
- Histologically or cytologically confirmed non-small cell bronchogenic carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma
- Not suitable for chemotherapy
- WHO Performance status 0,1, 2 or 3

Exclusion Criteria:

Newly diagnosed CNS mets
Less than 1 week since completion of prior radiotherapy or persistence of any radiotherapy related toxicity
ALT/AST greater than 5 x upper limit of normal
ANC less than 1.0 x 109/L or platelets less than 100 x 109/L

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Argentina, Australia, Brazil, Bulgaria, Canada, Chile, Estonia, Germany, Greece, Hungary, India, Ireland, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Romania, Russian Federation, Singapore, Slovakia, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, Venezuela

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00242801

Responsible Party

Secondary IDs ^††

ISEL

Study Sponsor ^†

AstraZeneca

Collaborators ^††

Investigators ^†

Study Director:

AstraZeneca Oncology Medical Science Direction

AstraZeneca

Information Provided By

AstraZeneca

Verification Date

April 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.