Solid Tumor
Conditions
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.
Interventions
DRUGGefitinib
Gefitinib 250mg will be administered orally daily
Sponsors
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate | up too 100 weeks |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival | expected average of 24 weeks |
| overall survival | up too 100 weeks |
| Number of subjects with Adverse Events as a measure of safety | up too 100 weeks |
Countries
South Korea
Outcome results
None listed