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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00242801

Purpose

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.

Condition	Intervention	Phase
NSCLC	Drug: Gefitinib	Phase III

Drug Information available for: ZD1839

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy 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

Further study details as provided by AstraZeneca:

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

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

Estimated Enrollment:	1692
Study Start Date:	July 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242801

Show 213 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Oncology Medical Science Direction

AstraZeneca

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	1839IL/0709, ISEL
Study First Received:	October 19, 2005
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00242801
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Non-small cell lung cancer
Gefitinib

ClinicalTrials.gov processed this record on January 16, 2009