A Study on the Long Term Survivals in an Expand Access Program (EAP) of Iressa - Full Text View

Purpose

The primary objective is to describe the quality of life of long-term survivors who are not terminated from the EAP.

Condition	Intervention	Phase
Non-small Cell Lung Cancer	Genetic: EGFR Mutation Test Genetic: Ki-67 protein expression	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer Smoking and Youth

Drug Information available for: Gefitinib

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Describe the quality of life of long-term survivors who are not terminated from the EAP [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To describe the current tumour control status via RECIST [ Designated as safety issue: Yes ]
To collect the risk factors related to prognosis in addition to the information already collected from EAP (age, gender, histology, smoking history, previous history of anti-cancer treatment, disease stage before starting gefitinib treatment, etc.) [ Designated as safety issue: Yes ]
To describe the treatment compliance of gefitinib in these patients [ Designated as safety issue: Yes ]
To describe the current clinical status of long-term survivors in the EAP program by clinical [ Designated as safety issue: Yes ]
To compare the key clinical features (age group, gender, histology, smoking history, disease stage, treatment-naive or pre-treated, response to prior chemotherapy,) in fast-progressors versus long-term survivals. [ Designated as safety issue: Yes ]

Enrollment:	59
Study Start Date:	August 2009
Study Completion Date:	April 2010
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

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. 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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provision of informed consent prior to any study specific procedures.
Participated in the Iressa EAP in China.
Diagnosed as NSCLC.
Patients who started EAP at least 3 years before this study initiated and have not yet terminated from the EAP (active long-term survivors).
Patients who consent to provide blood sample and available archival tumour tissue sample for EGFR gene testing (provision of tumour tissue sample is optional).

Exclusion Criteria:

Patients who disagree to participate this study.
Patients in whose medical objection was recorded to use the existing data from medical practice for scientific research.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000740

Locations

China, Beijing
Research Site
Beijing, Beijing, China
China, Guangdong
Research Site
Guangzhou, Guangdong, China
China, Hubei
Research Site
Wuhan, Hubei, China
China, Jiangsu
Research Site
Nanjing, Jiangsu, China
Research Site
Suzhou, Jiangsu, China
China, Shandong
Research Site
Jinan, Shandong, China
China, Shanghai
Research Site
Shanghai, Shanghai, China
China, Sichuan
Research Site
Chengdu, Sichuan, China
China, Zhejiang
Research Site
Hangzhou, Zhejiang, China

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Karen Atkin	AstraZeneca
Study Chair:	Louis Zhang	AstraZeneca
Principal Investigator:	Longyun Li	Peking Union Medical College Hospital

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Li L, Zhong W, Liao M, Chen L, Han B, Guan Z, Yu S, Liu X, Wu Y, Jiang G, Xu J, Chen J, Tao M, Luo R, Li W, Xu N, Zhao X, Wang M. [A Study on the Long-term Non-small Cell Lung Cancer Survivors in the Expand Access program of gefitinib in China]. Zhongguo Fei Ai Za Zhi. 2012 Jun 20;15(6):332-9. Chinese.

Responsible Party:	MC MD, AstraZeneca China
ClinicalTrials.gov Identifier:	NCT01000740 History of Changes
Other Study ID Numbers:	1839IL/0052 SubStudy
Study First Received:	September 7, 2009
Last Updated:	May 20, 2010
Health Authority:	China: Ethics Committee

Keywords provided by AstraZeneca:

EAP
Long term survival (3 years)
Gefitinib
efficacy

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases

Respiratory Tract Diseases
Gefitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013