Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111761
Status:
COMPLETED
Last Update Posted:
2013-12-12
First Post:
2005-05-25
Brief Title:
Evaluating Panitumumab ABX-EGF in Patients With Metastatic Colorectal Cancer
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Clinical Trial of the Safety and Efficacy of ABX-EGF in Combination With Irinotecan Leucovorin and 5-Fluorouracil in Subjects With Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2013-11
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 if panitumumab in combination with irinotecan leucovorin and 5-fluorouracil 5-FU is safe and efficacious in patients with metastatic colorectal cancer
Detailed Description:
Indication Metastatic Colorectal Cancer Primary Objective To assess the safety of ABX-EGF in combination with the FOLFIRI regimen in subjects with metastatic colorectal cancer The primary objective in the original protocol was to assess progression free survival after treatment with ABX-EGF in combination with the Saltz regimen in subjects with metastatic colorectal cancer
Secondary Objectives To assess the clinical efficacy of ABX-EGF in combination with the FOLFIRI regimen in subjects with metastatic colorectal cancer Secondary objectives in the original protocol were to assess safety and additional measures of the clinical efficacy of ABX-EGF in combination with the Saltz regimen in subjects with metastatic colorectal cancer
To assess the pharmacokinetics PK of ABX-EGF in combination with the FOLFIRI regimen in subjects with metastatic colorectal cancer Secondary objectives in the original protocol were to assess the PK of ABX-EGF in combination with the Saltz regimen and the PK of irinotecan IR and its active metabolite SN-38 when IR is given in combination with ABX-EGF leucovorin LV and 5-fluorouracil 5-FU in subjects with metastatic colorectal cancer
Secondary Objectives To assess the clinical efficacy of ABX-EGF in combination with the FOLFIRI regimen in subjects with metastatic colorectal cancer Secondary objectives in the original protocol were to assess safety and additional measures of the clinical efficacy of ABX-EGF in combination with the Saltz regimen in subjects with metastatic colorectal cancer
To assess the pharmacokinetics PK of ABX-EGF in combination with the FOLFIRI regimen in subjects with metastatic colorectal cancer Secondary objectives in the original protocol were to assess the PK of ABX-EGF in combination with the Saltz regimen and the PK of irinotecan IR and its active metabolite SN-38 when IR is given in combination with ABX-EGF leucovorin LV and 5-fluorouracil 5-FU in subjects with metastatic colorectal cancer
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