Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101920
Status:
COMPLETED
Last Update Posted:
2010-10-15
First Post:
2005-01-18
Brief Title:
ABX-EGF as Second Line Treatment of Advanced Non-Small-Cell Lung Cancer NSCLC
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Clinical Trial of the Safety and Efficacy of ABX-EGF as Second Line Treatment for Advanced Non-Small Lung Cancer
Status:
COMPLETED
Status Verified Date:
2010-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rationale Overexpression of epidermal growth factor receptor EGFR has been observed in kidney prostate colon lung breast and other cancers and is often associated with a poor prognosis TGFa and EGF the ligands for EGFR are also overexpressed in some of these tumor types suggesting a self-propagating stimulus that may be responsible for rapid tumor growth Blocking this stimulus by blocking activation of EGFR with ABX-EGF a fully human monoclonal antibody against EGFR may prevent tumor growth and perhaps shrink tumors Purpose This is a Phase 2 clinical trial to evaluate the safety and efficacy of ABX-EGF in the treatment of advanced NSCLC following failure of paclitaxel and carboplatin therapy on treatment arm 1 of Immunex Protocol 0540004 Amgen Protocol 20025404 Part 2
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