Official Title: “Multicentre, Open Label, Extension Study of Treatment With Gefitinib(IRESSA™) for Patients Completing Other Gefitinib Clinical Studies Who May Benefit From Gefitinib Treatment”

The purpose of this study is to provide gefitinib treatment to patients who, on completion or closure of other gefitinib clinical studies, were either receiving placebo treatment, or are continuing on the same dose and regimen of gefitinib established in their preceding study, for as long as the patients continue to derive benefit.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: ZD1839 (Iressa)
  • Gefitinib supplied for oral use at the dose and schedule that the patient received in the previous gefitinib clinical study. In the case of placebo patients, the gefitinib dose will be as described in the protocol of their previous gefitinib clinical study.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• There are no outcome variables in this programme. No formal analysis or statistical analysis will be performed on any data obtained. Serious adverse event data will be collected for regulatory reporting purposes only.
  • Time Frame: Study medication will continue until the patient shows disease progression, disease related symptomatic progression, withdraws consent or experiences toxicity leading to withdrawal ofstudy treatment.
    Safety Issue?: No

Inclusion Criteria:

• Patients who have completed preceding gefitinib therapy from either the 1839IL/0709 (250mg dosing) study or 1839IL/0710 (250mg dosing) study and in the opinion of the investigator may benefit from further gefitinib treatment.
• No more than 14 days lapse in gefitinib treatment between the patient completing the preceding gefitinib clinical study and beginning of this study except when agreed by the AstraZeneca physician.

Exclusion Criteria:

• Any evidence of clinically active interstitial lung disease (patients with chronic,stable, radiographic changes who are asymptomatic need not be excluded).
• In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).
• Withdrawal, at any time, from the preceding gefitinib study.
• Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's
• Wort

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Alison Armour Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00683306

Study ID Number: D791AC00008

ClinicalTrials.gov Identifier: NCT00683306

Health Authority: Austria: Ethikkommission