Spots Global Cancer Trial Database for Safety and Tolerability of I.V. Infusion of MB07133 in Patients With Unresectable Hepatocellular Carcinoma
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Trial Identification
Brief Title: Safety and Tolerability of I.V. Infusion of MB07133 in Patients With Unresectable Hepatocellular Carcinoma
Official Title: 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
Study ID: NCT00073736
Conditions
Study Description
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 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Isabela Niculae, MPH
Affiliation: Metabasis Therapeutics, Inc.
Role: STUDY_DIRECTOR
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