Hepatocellular Carcinoma Clinical Trial
Official title:
Recombinant Human Arginase I (rhArgI) for Patients With Advanced Hepatocellular Carcinoma (HCC)
The purpose of this study is to determine whether recombinant human arginase (PEG-BCT-100) is safe and effective in the treatment of advanced hepatocellular carcinoma (HCC).
The primary objectives of this study are:
- To evaluate any objective tumor responses to PEG-BCT-100 in HCC patients receiving
weekly doses of PEG-BCT-100 alone.
- To perform PK and PD analysis
- To measure Quality of Life of the patients
Secondary objectives of this study are:
- To define any toxicity associated with the metabolic and cellular alterations of ADD
relative to dose and PK of PEG-BCT-100 (rhArgIpeg5000).
- To confirm the safety and anti-tumor activity of PEG-BCT-100 at the preferred dose
(1600U/kg) in 50 patients (at least 18 evaluable subjects) with advanced HCC.
- To measure duration of response including Overall Survival and Time to Progression
analysis
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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