Clinical Trials /

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

NCT02447419

Description:

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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study to Evaluate the Safety and Efficacy of Gefitinib, in Subjects With EFGR Amplification Refractory Solid Tumors
  • Official Title:

Clinical Trial IDs

  • ORG STUDY ID: 2014-10-029
  • NCT ID: NCT02447419

Conditions

  • Solid Tumor

Interventions

DrugSynonymsArms
GefitinibGefitinib

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
GefitinibExperimentalGefitinib 250 mg will be administered orally daily
  • Gefitinib

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:20 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:overall response rate
Time Frame:up too 100 weeks
Safety Issue:
Description:

Secondary Outcome Measures

Measure:progression-free survival
Time Frame:expected average of 24 weeks
Safety Issue:
Description:
Measure:overall survival
Time Frame:up too 100 weeks
Safety Issue:
Description:
Measure:Number of subjects with Adverse Events as a measure of safety
Time Frame:up too 100 weeks
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Samsung Medical Center

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