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

Phase 2

Completed

• Conditions: Solid Tumor
• Interventions: Drug: Gefitinib

• Registration Number: NCT02447419
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-03
• Study First Submitted: 2015-05-14
• Study First Submitted QC: 2015-05-15
• Study First Posted: 2015-05-18
• Primary Completion: 2020-06
• Study Completion: 2020-12-01
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-13
• Last Update Posted: 2022-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gefitinib	Gefitinib	Gefitinib 250 mg will be administered orally daily

Primary Outcome Measures

Name	Time	Method
overall response rate	up too 100 weeks

Secondary Outcome Measures

Name	Time	Method
progression-free survival	expected average of 24 weeks
Number of subjects with Adverse Events as a measure of safety	up too 100 weeks
overall survival	up too 100 weeks

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of