Efficacy, Safety, Tolerability of Gefitinib as 1st Line in Caucasian Patients with EGFR mutation positive advanced NSCLC - IFUM
Study identifier:D791AC00014
ClinicalTrials.gov identifier:NCT01203917
EudraCT identifier:N/A
CTIS identifier:N/A
Recruitment Complete
Official Title
An Open Label, Multicentre, Single Arm Study to Characterise the Efficacy, Safety and Tolerability of Gefitinib 250 mg (IRESSA™) as First line Treatment in Caucasian Patients, who have Epidermal Growth Factor Receptor (EGFR) Mutation Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Medical condition
Caucasian patients with EGFR mutation positive advanced NSCLC
Phase
Phase 4
Healthy volunteers
No
Study drug
Gefitinib
Sex
All
Actual Enrollment
1060
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 01 Sept 2010
Primary Completion Date: 01 Aug 2012
Estimated Study Completion Date: 01 Dec 2016
Study design
Allocation: N/A
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Sept 2016 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Other: 1 gefitinib 250mg tablet | Drug: Gefitinib 250mg tablet oral, once daily until objective disease progression is documented or until other discontinuation criterion is met Other Name: IRESSA™ |
Contacts
Investigators
Principal Investigator
Haiyi Jiang
AstraZeneca
