Title
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
Phase
Phase 1/Phase 2Lead Sponsor
Ligand PharmaceuticalsStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Hepatocellular CarcinomaIntervention/Treatment
mb07133 ...Study Participants
28Hepatocellular 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.
7-day continuous infusion in 28-day cycles
7-day continuous infusion in 28-day cycles
7-day continuous infusion in 28-day cycles
7-day continuous infusion in 28-day cycles
7-day continuous infusion in 28-day cycles
7-day continuous infusion in 28-day cycles
7-day continuous infusion in 28-day cycles
7-day continuous infusion in 28-day cycles
7-day continuous infusion in 28-day cycles
7-day continuous infusion in 28-day cycles
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