Ignite Creation Date:
2024-05-06 @ 12:03 AM
Last Modification Date:
2024-10-26 @ 10:44 AM
Study NCT ID:
NCT01480141
Status:
WITHDRAWN
Last Update Posted:
2013-03-26
First Post:
2011-11-23
Brief Title:
A Window of Opportunity Trial of Afatinib In Early Stage Non-Small Cell Lung Cancer NSCLC
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
A Therapeutic Trial of Afatinib in the Neoadjuvant Setting Molecular Effects of Afatinib A Window of Opportunity Trial In Early Stage NSCLC
Status:
WITHDRAWN
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left MUSC no patient enrollments
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is for patients that have Non-Small Cell Lung Cancer NSCLC and he or she will have surgery to remove the tumor The main purpose of this study is to study how safe and suitable treatment with Afatinib is in participants before surgery to remove the tumor Another goal of the study is to see if treatment with Afatinib affects the growth and activity of the tumor Afatinib has not been approved for use by the FDA Food and Drug Administration and is experimental
In some persons the growth of cancer cells is thought to be stimulated by Epidermal Growth Factor EGF This is a protein found in the body which binds to the cell wall to sites called receptors and stimulates cell growth Some cells have too many receptors and uncontrolled growth and because of this develop into a cancer tumor There are several other cancer drugs that bind to these receptors to slow or stop cancer growth such as Gefitinib and erlotinib which are FDA approved and used for the treatment of NSCLC
The drug Afatinib has been shown to inhibit mutated EGF receptors in clinical trials and may be a candidate for the treatment of NSCLC and a variety of early stage cancers Participants in this study will take Afatinib by mouth in pill form for at least 14 days before having their scheduled surgery to remove their cancer tumor Participants will be observed for side effects and followed for 30 days after surgery to assess the results after surgery
In some persons the growth of cancer cells is thought to be stimulated by Epidermal Growth Factor EGF This is a protein found in the body which binds to the cell wall to sites called receptors and stimulates cell growth Some cells have too many receptors and uncontrolled growth and because of this develop into a cancer tumor There are several other cancer drugs that bind to these receptors to slow or stop cancer growth such as Gefitinib and erlotinib which are FDA approved and used for the treatment of NSCLC
The drug Afatinib has been shown to inhibit mutated EGF receptors in clinical trials and may be a candidate for the treatment of NSCLC and a variety of early stage cancers Participants in this study will take Afatinib by mouth in pill form for at least 14 days before having their scheduled surgery to remove their cancer tumor Participants will be observed for side effects and followed for 30 days after surgery to assess the results after surgery
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None