Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081900
Status:
TERMINATED
Last Update Posted:
2015-04-13
First Post:
2004-04-26
Brief Title:
A Safety and Efficacy Study of DENSPM in Patients With Liver Cancer Who Are Not Eligible for Surgical Care
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
A Phase 12 Study of DENSPM N1 N11-diethylnorspermine in Patients With Unresectable Hepatocellular Carcinoma
Status:
TERMINATED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was terminated early by Genzyme because there were insufficient data to support clinical benefit to HCC patients on the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Approximately 18-45 patients with Hepatocellular Carcinoma HCC will be treated with DENSPM at approximately 5 centers in the United States First we will be trying to determine the highest dose that can be given safely and is well tolerated this is called the maximally tolerated dose or the MTD for short Once that is established we will enroll additional patients to learn more about potential side effects and to see whether DENSPM can slow the growth of HCC tumors We also want to learn about the safety of DENSPM Many medications used to treat cancer cause side effects discomforts or illness In this study we want to understand what side effects occur in patients with HCC who are treated with DENSPMStudy was terminated after initial assessment of insufficient data to support clinical benefit in this population
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