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Study to Evaluate the Safety and Efficacy of Gefitinib, in Subjects With EFGR Amplification Refractory Solid Tumors

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ClinicalTrials.gov Identifier: NCT02447419
Recruitment Status : Unknown
Verified May 2019 by Jeeyun Lee, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : May 18, 2015
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Jeeyun Lee, Samsung Medical Center

Brief Summary:

This study is a single-arm,phase II study of gefitinib in patient with epidermal growth factor receptor amplification Refractory solid tumors.

Gefitinib 250 mg will be administered orally daily.

To investigate the efficacy and safety of gefitinib in patient with epidermal growth factor receptor amplification Refractory solid tumors.


Condition or disease Intervention/treatment Phase
Solid Tumor Drug: Gefitinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : December 3, 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Gefitinib

Arm Intervention/treatment
Experimental: Gefitinib
Gefitinib 250 mg will be administered orally daily
Drug: Gefitinib
Gefitinib 250mg will be administered orally daily




Primary Outcome Measures :
  1. overall response rate [ Time Frame: up too 100 weeks ]

Secondary Outcome Measures :
  1. progression-free survival [ Time Frame: expected average of 24 weeks ]
  2. overall survival [ Time Frame: up too 100 weeks ]
  3. Number of subjects with Adverse Events as a measure of safety [ Time Frame: up too 100 weeks ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Provision of fully informed consent prior to any study specific procedures.
  2. Patients must be ≥20 years of age.
  3. Patient with Epidermal growth factor receptor amplification Refractory Solid Tumors and/or specific sensitivity to Gefitinib by Avatar scan that has recurred or progressed following standard therapy, or that has not responded to standard therapy, or for which there is no standard therapy.

    (EGFR amplification by cancer scan + EGFR IHC overexpression +2 or +3)

  4. ECOG performance status 0-2.
  5. Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
  6. Adequate Organ Function Laboratory Values

    • Absolute neutrophil count ≥ 1.5 x 109/L, Hemoglobin ≥ 9g/dL, Platelets ≥ 100 x 109/L
    • bilirubin ≤ 1.5 x upper limit of normal AST/ALT ≤ 2.5 x upper limit of normal (5.0 X upper limit of normal , for subjects with liver metastases)
    • creatinine ≤1.5 x UNL
  7. Patients of child-bearing potential should be using adequate contraceptive measures (two forms of highly reliable methods) should not be breast feeding and must have a negative pregnancy test prior to start of dosing.
  8. Adequate heart function.

Exclusion Criteria:

  1. Patients with second primary cancer, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≤5 years.
  2. Has known active central nervous system (CNS) metastases.
  3. Has an active infection requiring systemic therapy.
  4. Pregnancy or breast feeding
  5. Patients with cardiac problem.
  6. KRAS mutation (codon 12 or 13) or BRAF mutation (V600)
  7. Any previous treatment with Gefitinib
  8. Patients with a risk factor of interstitial lung disease

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): NCT02447419


Contacts
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Contact: Jee Yun Lee, MD,Ph.D. 2-3410-3459 ext 82

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: yoon Jeong Ahn    221487395 ext 82      
Principal Investigator: Jeeyun Lee, M.D., Ph.D.         
Sponsors and Collaborators
Samsung Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jeeyun Lee, MD,PhD, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT02447419    
Other Study ID Numbers: 2014-10-029
First Posted: May 18, 2015    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Gefitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action