Iressa Follow-up Trial

This study is currently recruiting participants.

Verified by AstraZeneca, April 2009

First Received: July 26, 2006 Last Updated: April 30, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00357734

Purpose

The purpose of this study is to assess the long-term safety profile and the secondary objective to estimate clinical benefit of ZD1839 (gefitinib).

Condition	Intervention	Phase
Lung Cancer Breast Cancer	Drug: Gefitinib	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Multicenter Open-Label, Long-Term Safety Trial of Treatment Extension With ZD1839 in Patients Who Have Been Treated in Other ZD1839 Clinical Trials

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Lung Cancer

Drug Information available for: ZD1839

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To assess the long-term safety profile and the secondary objective to estimate clinical benefit of ZD1839.

Secondary Outcome Measures:

To estimate clinical benefit of ZD1839 therapy by assessing progression free survival and overall survival.

Estimated Enrollment:	100
Study Start Date:	May 2004
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

Provision of written informed consent to participate in the trial.
Female or male aged 18 years and over.
Patients with previously diagnosed cancer who have been treated with ZD1839 in a parent ZD1839 clinical trial and may benefit from continuation

Exclusion Criteria:

Known severe hypersensitivity to ZD1839
Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort.
Withdrawal from a parent ZD1839 trial because of tumor progress

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357734

Contacts

Contact: AstraZeneca Germany Clinical Study Information

+49 - (0)4103 - 708 3648

Manfred.Klevesath@astrazeneca.com

Locations

Germany
Research Site	Completed
Gauting, Germany
Research Site	Completed
Hemer, Germany
Research Site	Recruiting
Minden, Germany
Research Site	Recruiting
Jena, Germany
Research Site	Recruiting
Tuebingen, Germany
Research Site	Completed
Heidelberg, Germany
Research Site	Completed
Berlin, Germany
Research Site	Recruiting
Grosshansdorf, Germany

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Germany Medical Director, MD

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca ( Alison Armour )
Study ID Numbers:	1839IL/0555, D7913L00008
Study First Received:	July 26, 2006
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00357734 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

lung cancer
breast cancer

Study placed in the following topic categories:

Thoracic Neoplasms
Respiratory Tract Diseases
Skin Diseases
Lung Neoplasms

Lung Diseases
Breast Neoplasms
Gefitinib
Breast Diseases

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases

Skin Diseases
Lung Neoplasms
Lung Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009