Iressa Follow-up Trial

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00357734

First received: July 26, 2006

Last updated: February 12, 2015

Last verified: January 2015

History of Changes

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 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Drug Information available for: Gefitinib

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. [ Time Frame: Until 30 days after the last dose of trial drug ] [ Designated as safety issue: No ]
Any AEs and SAEs occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease

Secondary Outcome Measures:

To estimate clinical benefit of ZD1839 therapy by assessing progression free survival and overall survival. [ Time Frame: Every 3 months until death of last patient ] [ Designated as safety issue: No ]
Patients are followed for progression and overall survival


Estimated Enrollment:	14
Study Start Date:	January 2005
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	December 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Gefitinib (ZD1839) ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial	Drug: Gefitinib ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


Germany
Research Site
Freiburg, Germany
Research Site
Gauting, Germany
Research Site
Großhansdorf, Germany
Research Site
Hemer, Germany
Research Site
Jena, Germany
Research Site
Minden, Germany
Research Site
Tübingen, Germany

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	AstraZeneca Germany Medical Director, MD	AstraZeneca

More Information

No publications provided


Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00357734 History of Changes
Other Study ID Numbers:	1839IL/0555, D7913L00008
Study First Received:	July 26, 2006
Last Updated:	February 12, 2015
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:


lung cancer breast cancer

ClinicalTrials.gov processed this record on March 03, 2015

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