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

Samsung Medical Center

Status and phase: Completed; Phase 2

Conditions: Solid Tumor

Treatments: Drug: Gefitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT02447419

2014-10-029

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Gefitinib

Experimental group

Description:

Gefitinib 250 mg will be administered orally daily

Treatment:

Drug: Gefitinib