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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00073736
Recruitment Status : Completed
First Posted : December 5, 2003
Last Update Posted : August 12, 2011
Information provided by:
Ligand Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: MB07133 300mg/m2/day Drug: MB07133 600 mg/m2/day Drug: MB07133 1200 mg/m2/day Drug: MB07133 1800 mg/m2/day Drug: MB07133 2400 mg/m2/day Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2003
Actual Primary Completion Date : July 2007

Arm Intervention/treatment
Experimental: MB07133 Dose Level 1
7-day continuous infusion in 28-day cycles
Drug: MB07133 300mg/m2/day
7-day continuous infusion in 28-day cycles

Experimental: MB07133 Dose Level 2
7-day continuous infusion in 28-day cycles
Drug: MB07133 600 mg/m2/day
7-day continuous infusion in 28-day cycles

Experimental: MB07133 Dose Level 3
7-day continuous infusion in 28-day cycles
Drug: MB07133 1200 mg/m2/day
7-day continuous infusion in 28-day cycles

Experimental: MB07133 Dose Level 4
7-day continuous infusion in 28-day cycles
Drug: MB07133 1800 mg/m2/day
7-day continuous infusion in 28-day cycles

Experimental: MB07133 Dose Level 5
7-day continuous infusion in 28-day cycles
Drug: MB07133 2400 mg/m2/day
7-day continuous infusion in 28-day cycles

Primary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 7-day continuous infusion every 28-days as tolerated ]
    To determine the dose-limiting toxicities (DLT) of MB07133; To determine the maximum-tolerated continuous infusion dose (MTD) of MB07133

Secondary Outcome Measures :
  1. Determine effect of MB07133 on tumor size [ Time Frame: 28 day cycles ]
    To determine the effect on HCC tumor size by using CT scanning, alpha-fetoprotein (AFP) concentration, and performance status.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with a diagnosis of local unresectable HCC confirmed by histology using fine needle aspirate (FNA) or liver biopsy. "Local" is defined as disease either restricted to the liver or contiguous with the liver and no identifiable extrahepatic disease.
  • 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
  • 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

Exclusion Criteria:

  • History of or presence of clinically significant acute or unstable cardiovascular, cerebrovascular (stroke), renal, GI, pulmonary, immunological (with the exception of the presence of hepatitis B virus [HBV], HCV hepatitis, or cirrhosis), endocrine, or central nervous system disorders
  • Patient has a history of cancer other than hepatocellular (excluding resected basal cell carcinoma; or curatively resected stage 1 or less cervical cancer if disease free for 5 years or more).
  • Patients with distant metastasis or extrahepatic disease
  • An Eastern Cooperative Oncology Group (ECOG) performance status score of greater than or equal to 2
  • Current encephalopathy or current treatment for encephalopathy
  • History of drug or alcohol abuse within 6 months before screening
  • History of, or current clinically significant mental disorder or an antagonistic personality that compromises the validity of the informed consent
  • A documented variceal hemorrhage within 4 months of screening
  • Neutrophil count less than or equal to 1,500/mm3, platelet count less than or equal to 100,000/mm3, hemoglobin less than or equal to 8.5 g/dL, or a Prothrombin Time (INR) greater than 1.3 (vitamin K supplementation allowed)
  • Serum creatinine greater than 1.1 times the upper limit of normal
  • History of human immunodeficiency virus or acquired immune deficiency syndrome
  • Use of an investigational drug or product or participation in a drug study within 30 days before dosing
  • Liver function defined as: serum bilirubin greater than 1.5 times the upper limit of normal or an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 5 times upper limit of normal, or serum albumin less than 3.2 g/dL
  • History of gout or abnormal uric acid metabolism
  • The clinical presence of ascites
  • Treatment of HCC within 30 days of screening by chemotherapy or treatment of the target lesion(s) by chemoembolization, PEI, or surgery
  • Radiofrequency ("RF") ablation of the target lesion(s) within 60 days of screening
  • Subjects with a life expectancy of less than 12 weeks
  • Subjects having received an organ transplant
  • Subjects currently receiving coumadin or heparin
  • Pregnant or nursing women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00073736

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United States, California
University of California at Irvine
Orange, California, United States, 92868
Hong Kong
Prince of Wales Hospital - Comprehensive Cancer Trial Unit
Shatin, New Territories, Hong Kong
Tri-Services General Hospital
Taipei, Nei Hu District, Taiwan, 114
Chang-Gung Memorial Hospital
Taipei, Taoyuan County, Taiwan, 333
Sponsors and Collaborators
Ligand Pharmaceuticals
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Study Director: Isabela Niculae, MPH Metabasis Therapeutics, Inc.
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Responsible Party: Director, Project Management, Ligand Pharmaceuticals Identifier: NCT00073736    
Other Study ID Numbers: HCC-101
First Posted: December 5, 2003    Key Record Dates
Last Update Posted: August 12, 2011
Last Verified: August 2011
Keywords provided by Ligand Pharmaceuticals:
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs