Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00083616
Status:
COMPLETED
Last Update Posted:
2014-01-10
First Post:
2004-05-26
Brief Title:
Evaluating Panitumumab ABX-EGF Monotherapy in Patients With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine Irinotecan and Oxaliplatin Chemotherapy
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Phase 2 Multicenter Single Arm Clinical Trial of ABX-EGF Monotherapy in Subjects With Metastatic Colorectal Cancer Following Treatment With Fluoropyrimidine Irinotecan and Oxaliplatin Chemotherapy
Status:
COMPLETED
Status Verified Date:
2013-12
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:
The purpose of this study is to determine that panitumumab will have clinically meaningful anti-tumor activity in patients with metastatic colorectal cancer who have developed progressive disease or relapsed while on or after prior fluoropyrimidine irinotecan and oxaliplatin chemotherapy
Detailed Description:
Panitumumab was administered once every 2 weeks until participants developed progressive disease were unable to tolerate panitumumab or discontinued treatment for other reasons eg administrative decision Participants then attended a safety follow-up visit 4 weeks from the last panitumumab infusion Participants were subsequently contacted every 3 months from the last panitumumab infusion through month 24 to assess disease status and survival
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