Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00073736
Status:
COMPLETED
Last Update Posted:
2011-08-12
First Post:
2003-12-03
Brief Title:
Safety and Tolerability of IV Infusion of MB07133 in Patients With Unresectable Hepatocellular Carcinoma
Sponsor:
Ligand Pharmaceuticals
Organization:
Ligand Pharmaceuticals
Study Overview
Official Title:
A Phase 12 Open-Label Study to Assess the Safety Tolerability and Pharmacokinetics of Intravenous Infusion of MB07133 in Subjects With Unresectable Hepatocellular Carcinoma and Child-Pugh Class A Liver Function
Status:
COMPLETED
Status Verified Date:
2011-08
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:
Hepatocellular carcinoma HCC is the most common primary cancer of the liver MB07133 is being developed for the treatment of inoperable HCC using a platform technology known as HepDirectTM which enables drugs to be targeted specifically to the liver The objective for this study is to determine the safety and tolerability of MB07133
Detailed Description:
To determine the maximum tolerated dose of MB07133 when administered as a 7-day continuous iv To characterize the safety profile and the pharmacokinetics of MB07133 and metabolites during and after continuous infusion To determine the effect of MB07133 on hepatocellular carcinoma HCC tumor size
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