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Sponsors and Collaborators: |
Chonnam National University Hospital AstraZeneca |
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Information provided by: | Chonnam National University Hospital |
ClinicalTrials.gov Identifier: | NCT00824746 |
A single arm, open label, prospective, phase II trial of Gefitinib retreatment for the advanced or metastatic (IIIb and IV) NSCLC patients who previously responded to gefitinib And progressive disease should be observed with at least one prior regimen following previous gefitinib failure.
Primary endpoint
Secondary endpoints
Condition | Intervention | Phase |
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Carcinoma, Non-Small-Cell Lung |
Drug: Gefitinib retreatment |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Retreatment of Gefitinib in the Patients With Non-Small Cell Lung Cancer (NSCLC) Previously Responded to Gefitinib A Single Arm, Open Label, Phase II Study |
Estimated Enrollment: | 20 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | June 2011 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Single arm: Experimental
Gefitinib retreatment
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Drug: Gefitinib retreatment
phase II trial of Gefitinib retreatment for the advanced or metastatic (IIIb and IV) NSCLC patients who previously responded to gefitinib And progressive disease should be observed with at least one prior regimen following previous EGFR-TKI failure.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of, Jeonnam | |
Chonnam National University Hwasun Hospital | |
Hwasun-gun, Jeonnam, Korea, Republic of, 519-809 |
Principal Investigator: | Young-Chul Kim, MD, PhD | Chonnam National University Hospital |
Responsible Party: | Chonnam National University Hwasun Hospital ( Young-Chul Kim, MD, PhD. Professor ) |
Study ID Numbers: | D791JL00001 |
Study First Received: | January 16, 2009 |
Last Updated: | January 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00824746 History of Changes |
Health Authority: | South Korea: Institutional Review Board |
Gefitinib Recurrence Carcinoma, Non-Small-Cell Lung |
Thoracic Neoplasms Respiratory Tract Diseases Lung Neoplasms Lung Diseases Non-small Cell Lung Cancer Protein Kinase Inhibitors |
Gefitinib Carcinoma, Non-Small-Cell Lung Recurrence Neoplasms, Glandular and Epithelial Carcinoma |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions Carcinoma |
Neoplasms Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Therapeutic Uses Lung Diseases Carcinoma, Non-Small-Cell Lung Gefitinib Neoplasms, Glandular and Epithelial |