A study on the long term survivals in an Expand Access Program (EAP) of Iressa
Study identifier:1839IL/0052 SubStudy
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An International Expanded Access Clinical Programme with ZD1839 (IRESSATM) for Patients with Advanced Non-small Cell Lung Cancer (NSCLC) China amendment 1: A study on the long term survivals in an Expand Access Program (EAP) of Iressa
Medical condition
Non-small Cell Lung Cancer
Phase
Phase 4
Healthy volunteers
No
Study drug
-
Sex
All
Actual Enrollment
59
Study type
Interventional
Age
N/A
Date
Study Start Date: 01 Aug 2009
Primary Completion Date: 01 Apr 2010
Study Completion Date: 01 Apr 2010
Study design
Allocation: Non-randomized
Endpoint Classification: None
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Dec 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Long term survivors who has been used IRESSA for more than 3 years and are still on gefitinib treatment | Genetic: EGFR Mutation Test Explore the EGFR mutation status from both tumour tissue sample and the free DNA in the peripheral blood using appropriate method(s) which may include ARMS assay, ME-PCR coupled sequencing and regular sequencing. Other Name: N/A Genetic: Ki-67 protein expression Ki-67 protein expression in tissue will be analysed by IHC method. |
| No Intervention: 2 Long term survivors who has been used IRESSA for more than 3 years but have already terminated from EAP | - |
| No Intervention: 3 Fast-progressors who defined as no more than 1 follow-up visit after recruitment with the reason of discontinuation being | - |
Contacts
Investigators
Principal Investigator
Karen Atkin
AstraZeneca
