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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
7-day continuous infusion in 28-day cycles
7-day continuous infusion in 28-day cycles
7-day continuous infusion in 28-day cycles
University of California at Irvine
Orange, California, United States
Prince of Wales Hospital - Comprehensive Cancer Trial Unit
Shatin, New Territories, Hong Kong
Tri-Services General Hospital
Taipei, Nei Hu District, Taiwan
Chang-Gung Memorial Hospital
Taipei, Taoyuan County, Taiwan
Safety and tolerability
To determine the dose-limiting toxicities (DLT) of MB07133; To determine the maximum-tolerated continuous infusion dose (MTD) of MB07133
Time frame: 7-day continuous infusion every 28-days as tolerated
Determine effect of MB07133 on tumor size
To determine the effect on HCC tumor size by using CT scanning, alpha-fetoprotein (AFP) concentration, and performance status.
Time frame: 28 day cycles
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7-day continuous infusion in 28-day cycles
7-day continuous infusion in 28-day cycles