NCT00073736

Safety and Tolerability of I.V. Infusion of MB07133 in Patients With Unresectable Hepatocellular Carcinoma

A Phase 1/2 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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Ligand Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 i.v. 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.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	MB07133 300mg/m2/day	7-day continuous infusion in 28-day cycles
DRUG	MB07133 600 mg/m2/day	7-day continuous infusion in 28-day cycles
DRUG	MB07133 1200 mg/m2/day	7-day continuous infusion in 28-day cycles
DRUG	MB07133 1800 mg/m2/day	7-day continuous infusion in 28-day cycles
DRUG	MB07133 2400 mg/m2/day	7-day continuous infusion in 28-day cycles

Timeline

• Start date: 2003-09-01
• Primary completion: 2007-07-01
• First posted: 2003-12-05
• Last updated: 2011-08-12

Locations

4 sites across 3 countries: United States, Hong Kong, Taiwan