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.

Treatment

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.

Arm Label

Target Number of Participant

Arm Type

Arm 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.

Gender

Age

Description

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.A 12-lead ECG (electrocardiogram) with no clinically significant changes that does not require normal or medical intervention, and other cardiac functions without a history of other than symptomatic QTc.

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.Patients with a clinically significant gastrointestinal disorder that may lead to impairment in the dosing, distribution or absorption of the test drug, such as when the tablet is not orally administrable.
4.Has an active infection requiring systemic therapy.
5.Patients with cardiac problem.
6.Patients with uncontrolled seizures, central nervous system disorders or psychiatric disorders who are unable to voluntarily agree to clinical research under the judgment of the investigator
7.Pregnancy or breast feeding
8.Patients with active infection or other uncontrolled disease
9.Any previous treatment with Gefitinib
10.Patients with a risk factor of interstitial lung disease

Overall response rate

It is defined as the final analysis date of the data

Progression of survival

It is defined as the final analysis date of the data

Overall survival

It is defined as the final analysis date of the data

Toxicity assessment

It is defined as the final analysis date of the data

Exploratory biomarker assessment

It is defined as the final analysis date of the data