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

NCT02447419 | Completed Phase 2

• 1 other identifier: 2014-10-029
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• overall response rate

  up too 100 weeks

Secondary Outcomes (3)

• 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

Study Arms (1)

Gefitinib

EXPERIMENTAL

Gefitinib 250 mg will be administered orally daily

Drug: Gefitinib

Interventions

Gefitinib DRUG

Gefitinib 250mg will be administered orally daily

Gefitinib

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

• Byeon S, Hong JY, Lee J, Nam DH, Park SH, Park JO, Park YS, Lim HY, Kang WK, Kim ST. Use of Gefitinib in EGFR-Amplified Refractory Solid Tumors: An Open-Label, Single-Arm, Single-Center Prospective Pilot Study. Target Oncol. 2020 Apr;15(2):185-192. doi: 10.1007/s11523-020-00706-0.

  PMID: 32107712 DERIVED

MeSH Terms

Interventions

Gefitinib

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: May 14, 2015
• First Posted: May 18, 2015
• Study Start: December 3, 2014
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

KR (1)