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

Solid Tumor Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02447419
• Other study ID #: 2014-10-029
• Status: Completed
• Phase: Phase 2
• Start date: December 3, 2014
• Est. completion date: December 1, 2020

Study information

• Verified date: June 2022
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 1, 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• Gefitinib
Gefitinib 250mg will be administered orally daily

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate		up too 100 weeks
Secondary	progression-free survival		expected average of 24 weeks
Secondary	overall survival		up too 100 weeks
Secondary	Number of subjects with Adverse Events as a measure of safety		up too 100 weeks