Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further 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 Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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. ] [ Designated as safety issue: No ]
|Study Start Date:||January 2005|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
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.
Other Name: Iressa