Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00102024
Status:
TERMINATED
Last Update Posted:
2010-08-27
First Post:
2005-01-19
Brief Title:
Safety and Activity of 90Y-Labeled IDEC-159 in Subjects With Metastatic Colorectal Adenocarcinoma
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Phase III Open-Label Dose-Escalation Study to Evaluate the Safety and Activity of Single Dose 90Y-Labeled IDEC-159 Humanized Domain Deleted Anti TAG-72 Monoclonal Antibody in Subjects With Metastatic Colorectal Adenocarcinoma
Status:
TERMINATED
Status Verified Date:
2010-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase III open-label dose-escalating study in patients with metastatic colorectal cancer The objectives of the study are to obtain information on the safety of radiolabeled IDEC-159 as well as its activity in colorectal cancer Another objective is to determine the maximum tolerated dose MTD The study duration is 2 years with visits occuring daily andor weekly for the first 3 months and every 6 weeks until the end of the 2 year period
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