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Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis

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ClinicalTrials.gov Identifier: NCT01776684
Recruitment Status : Unknown
Verified January 2013 by Myung-Ju Ahn, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : January 28, 2013
Last Update Posted : January 28, 2013
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Myung-Ju Ahn, Samsung Medical Center

Brief Summary:
To detect resistance gene from serially collected plasma DNA in non-small cell lung cancer harbouring EGFR activating mutation who are being treated with EGFR TKIs by using castPCR method.

Condition or disease Intervention/treatment Phase
EGFR Mutation Positive Non-small Cell Lung Cancer Drug: EGFR TKIs (gefitinib, erlotinib, afatinib, et al) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Detection of Resistance Genes From Serially Collected Plasma DNA in Non-small Cell Lung Cancer Patients Harboring EGFR Activating Mutation Who Are Being Treated With EGFR TKIs
Study Start Date : June 2012
Estimated Primary Completion Date : May 2014
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib
U.S. FDA Resources

Arm Intervention/treatment
Experimental: EGFR positive arm
Patients with NSCLC harboring activating EGFR mutation (deletion in exon 19, L858R mutation in exon 21)
Drug: EGFR TKIs (gefitinib, erlotinib, afatinib, et al)



Primary Outcome Measures :
  1. detection of resistant gene [ Time Frame: 24 months ]
    To evaluate the efficiency of castPCR method for detection of resistance genes, especially, T790M mutation from serially collected plasma DNA in non-small cell lung cancer patients harboring EGFR activating mutation who are being treated with EGFR TKIs



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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Histologically confirmed NSCLC 2. Aged of or older than 20 years 3. ECOG performance status 0-2 4. Adequate hematological, renal, hepatic function 5. Patients with tumors harboring EGFR mutation (del 19 or L858R mutation) 6. Patient who are about to be treated with EGFR TKI (gefitinib, erlotinib or other EGFR TKI) 7. At least more than one measurable disease 8. Informed consent

Exclusion Criteria:

  • 1. Active infection 2. Active bleeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01776684


Contacts
Contact: Myung-Ju Ahn, M.D., Ph.D. silkahn@skku.edu
Contact: Jong-Mu Sun, M.D., Ph.D. tntntn3@gmail.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Myung-Ju Ahn, M.D., Ph.D.       silkahn@skku.edu   
Sponsors and Collaborators
Samsung Medical Center
AstraZeneca

Responsible Party: Myung-Ju Ahn, M.D., Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01776684     History of Changes
Other Study ID Numbers: 2011-10-054
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: January 2013

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action