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

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT02447419

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor	Drug: Gefitinib	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

16 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Actual Study Start Date :

Dec 3, 2014

Actual Primary Completion Date :

Jun 1, 2020

Actual Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gefitinib Gefitinib 250 mg will be administered orally daily	Drug: Gefitinib Gefitinib 250mg will be administered orally daily

Arm

Intervention/Treatment

Experimental: Gefitinib

Gefitinib 250 mg will be administered orally daily

Drug: Gefitinib

Gefitinib 250mg will be administered orally daily

Outcome Measures

Primary Outcome Measures

overall response rate [up too 100 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Provision of fully informed consent prior to any study specific procedures.
Patients must be ≥20 years of age.
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)

ECOG performance status 0-2.
Have measurable or evaluated disease based on RECIST1.1. as determined by investigator.
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

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.
Adequate heart function.

Exclusion Criteria:

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.
Has known active central nervous system (CNS) metastases.
Has an active infection requiring systemic therapy.
Pregnancy or breast feeding
Patients with cardiac problem.
KRAS mutation (codon 12 or 13) or BRAF mutation (V600)
Any previous treatment with Gefitinib
Patients with a risk factor of interstitial lung disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul		Korea, Republic of

Sponsors and Collaborators

Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jeeyun Lee, MD,PhD, Samsung Medical Center

ClinicalTrials.gov Identifier:

NCT02447419

Other Study ID Numbers:

2014-10-029

First Posted:

May 18, 2015

Last Update Posted:

Jun 15, 2022

Last Verified:

Jun 1, 2022

Additional relevant MeSH terms:

Gefitinib

Study Results

No Results Posted as of Jun 15, 2022