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Evaluation of EGFR TKI Resistance Mechanism Using Plasma DNA Analysis

This study is currently recruiting participants.
Verified January 2013 by Samsung Medical Center
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Myung-Ju Ahn, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01776684
First received: January 23, 2013
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  Purpose

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 Intervention
EGFR Mutation Positive Non-small Cell Lung Cancer
 Drug: EGFR TKIs (gefitinib, erlotinib, afatinib, et al)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • detection of resistant gene [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: January 23, 2013
Last Updated: January 25, 2013
Health Authority: Korea: Food and Drug Administration

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
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013