Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2026-01-03 @ 6:42 PM
Study NCT ID:
NCT00683306
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2018-09-13
First Post:
2008-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment
Sponsor:
AstraZeneca
Organization:
Study Overview
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
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: