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
1 other identifier
interventional
28
3 countries
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hepatocellular-carcinoma
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
December 3, 2003
CompletedFirst Posted
Study publicly available on registry
December 5, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedAugust 12, 2011
August 1, 2011
3.8 years
December 3, 2003
August 10, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability
To determine the dose-limiting toxicities (DLT) of MB07133; To determine the maximum-tolerated continuous infusion dose (MTD) of MB07133
7-day continuous infusion every 28-days as tolerated
Secondary Outcomes (1)
Determine effect of MB07133 on tumor size
28 day cycles
Study Arms (5)
MB07133 Dose Level 1
EXPERIMENTAL7-day continuous infusion in 28-day cycles
MB07133 Dose Level 2
EXPERIMENTAL7-day continuous infusion in 28-day cycles
MB07133 Dose Level 3
EXPERIMENTAL7-day continuous infusion in 28-day cycles
MB07133 Dose Level 4
EXPERIMENTAL7-day continuous infusion in 28-day cycles
MB07133 Dose Level 5
EXPERIMENTAL7-day continuous infusion in 28-day cycles
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
University of California at Irvine
Orange, California, 92868, United States
Prince of Wales Hospital - Comprehensive Cancer Trial Unit
Shatin, New Territories, Hong Kong
Tri-Services General Hospital
Taipei, Nei Hu District, 114, Taiwan
Chang-Gung Memorial Hospital
Taipei, Taoyuan County, 333, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Isabela Niculae, MPH
Metabasis Therapeutics, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 3, 2003
First Posted
December 5, 2003
Study Start
September 1, 2003
Primary Completion
July 1, 2007
Last Updated
August 12, 2011
Record last verified: 2011-08