Iressa Follow-up Trial

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: July 26, 2006
Last updated: June 3, 2015
Last verified: June 2015
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:

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

Enrollment: 14
Study Start Date: January 2005
Study Completion Date: May 2015
Primary Completion Date: May 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


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

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 identifier: NCT00357734

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
Study Director: AstraZeneca Germany Medical Director, MD AstraZeneca
  More Information

Responsible Party: AstraZeneca Identifier: NCT00357734     History of Changes
Other Study ID Numbers: 1839IL/0555  D7913L00008 
Study First Received: July 26, 2006
Last Updated: June 3, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:
lung cancer
breast cancer

Additional relevant MeSH terms:
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses processed this record on April 27, 2016