Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107861
Status:
COMPLETED
Last Update Posted:
2009-07-14
First Post:
2005-04-11
Brief Title:
Interferon-Beta Gene Transfer AdhIFN-β as Treatment for Refractory Colorectal Carcinoma With Liver Metastases
Sponsor:
Biogen
Organization:
Biogen
Study Overview
Official Title:
A Phase III Study of Interferon-Beta Gene Transfer AdhIFN-β in the Treatment of Refractory Colorectal Carcinoma With Liver Metastases
Status:
COMPLETED
Status Verified Date:
2009-07
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 study will be conducted in subjects with refractory colorectal carcinoma with unresectable liver metastases The purposes of the study are
to evaluate the safety and any harmful effects of an intravenous injection of AdhIFN-β
help determine whether the virus carrying the interferon-beta gene will enter the bloodstream and liver tumor cells and cause the cancer cells to die
to evaluate the safety and any harmful effects of an intravenous injection of AdhIFN-β
help determine whether the virus carrying the interferon-beta gene will enter the bloodstream and liver tumor cells and cause the cancer cells to die
Detailed Description:
This trial is a clinical research study of AdhIFN-β an investigational replication-defective recombinant adenovirus containing the human interferon beta gene for people that have refractory colorectal carcinoma with liver metastases Scientists have been exploring a variety of approaches to develop medications to treat patients with refractory colorectal carcinoma with liver metastases a disease for which current treatment provides only limited relief so there is a need for new medications
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