Spots Global Cancer Trial Database for Study of Pegylated Human Recombinant Arginase for Liver Cancer (BCT-100-002)

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Trial Identification

Brief Title: Study of Pegylated Human Recombinant Arginase for Liver Cancer (BCT-100-002)

Official Title: Recombinant Human Arginase I (rhArgI) for Patients With Advanced Hepatocellular Carcinoma (HCC)

Study ID: NCT01092091

Conditions

Neoplasm

Hepatocellular Carcinoma

Interventions

Pegylated Recombinant Human Arginase I

Study Description

Brief Summary: 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).

Detailed Description: 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