Study to Evaluate the Safety and Efficacy of Gefitinib, i... | NCT02447419

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

NCT02447419

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Jun 15, 2022Actual

Enrollment

16Actual

Phase

Phase 2

Conditions

Solid Tumor

Interventions

Gefitinib

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 3, 2014Actual

Primary Completion Date

Jun 2020Actual

Completion Date

Dec 1, 2020Actual

First Submitted Date

May 14, 2015

First Submission Date that Met QC Criteria

May 15, 2015

First Posted Date

May 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2022

Last Update Posted Date

Jun 15, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Label	Type	Description	Intervention Names
Gefitinib	Experimental	Gefitinib 250 mg will be administered orally daily	Drug: Gefitinib

Name	Type	Description	Arm Group Labels	Other Names
Gefitinib	Drug	Gefitinib 250mg will be administered orally daily	Gefitinib

Measure	Description	Time Frame
overall response rate		up too 100 weeks

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds