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

Study drug

Sex

All

Actual Enrollment

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

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Beijing, Beijing, China

Location

Research Site

Chengdu, Sichuan, China

Location

Research Site

Guangzhou, Guangdong, China

Location

Research Site

Hangzhou, Zhejiang, China

Location

Research Site

Jinan, Shandong, China

Location

Research Site

Nanjing, Jiangsu, China

Location

Research Site

Shanghai, Shanghai, China

Location

Research Site

Suzhou, Jiangsu, China

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	-

"There is no result for the study"

Documents available

CSR-1839IL-0052 SubStudy.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca China Clinical Study Information

+86 21 5256 4555-5038

loius.zhang@astrazeneca.com

Investigators

Principal Investigator

Karen Atkin

AstraZeneca

A study on the long term survivals in an Expand Access Program (EAP) of Iressa

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Documents available

CSR-1839IL-0052 SubStudy.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator