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



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

For Condition: Hepatocellular Carcinoma
Status: Recruiting
Sponsor(s): Metabasis Therapeutics ,
Synopsis: 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.
Details: To determine the maximum tolerated dose of MB07133 when administered as a 7-day continuous infusion. Characterize the safety profile of MB07133. Characterize the pharmacokinetics of MB07133 and metabolites during and after continuous infusion. Determine the effect of MB07133 on hepatocellular carcinoma (HCC) tumor size
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: - Patients with a diagnosis of unresectable HCC confirmed by histology using fine needle aspirate (FNA) or liver biopsy. - Patients with Child-Pugh Class A liver function. For purposes of this trial, an eligible patient must not have Encephalopathy or Ascites and the total Child-Pugh score cannot be greater than 6 at baseline - Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <5 times the upper limit of normal - Males or females 18 years of age or older - Ability to provide written informed consent before initiation of any study-related procedures and ability, in the opinion of the Principal Investigator, to comply with all the requirements of the study - Male and female subjects who are surgically sterile, who remain abstinent, or who agree to practice double barrier forms of birth control from screening through 30 days (females) and 90 days (males), from the last dose of study medication
Total Enrollment: 21

Location and Contact Information:

University of California at Irvine *Recruiting*
Orange,  California,  92868
United States
Recruiting Denise  Fields 714-456-3887

Prince of Wales Hospital - Comprehensive Cancer Trial Unit *Recruiting*
Shatin,  , 
Hong Kong
Recruiting Maria  Lai (852) 26321169


Additional Information:
Study ID Numbers:
  HCC-101; 
Study Start Date: September 2003
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073736

Other Hepatocellular Carcinoma Studies:
1. Prevention of Recurrent Hepatitis B after Liver Transplantation

2. Safety and Efficacy of Doxorubicin Adsorbed to Magnetic Beads

3. T138067-sodium versus doxorubicin in chemotherapy-naive, unresectable, hepatocellular carcinoma patients

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

5. Study of T900607-sodium in chemotherapy naive patients with hepatocellular carcinoma.

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