NCT01092091

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Bio-Cancer Treatment International Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Neoplasm
• Hepatocellular Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Pegylated Recombinant Human Arginase I	Weekly dose of PEG-BCT-100 for at least 8 weeks (or until disease progression) at 1600U/kg

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2010-03-24
• Last updated: 2012-03-14

Locations

1 site across 1 country: Hong Kong