Hepatocellular Carcinoma Clinical Trial
Official title:
Recombinant Human Arginase I (rhArgI) for Patients With Advanced Hepatocellular Carcinoma (HCC): An Adaptive Design Dose Escalation Trial With Addition of Standard Doxorubicin Treatment
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 establish a safe dose level for weekly intravenous administration of PEG- BCT-100
(rhArgIpeg5000) based on clinical and laboratory safety assessments following a range
of doses (from 500 to >5000 U/kg).
- To define the optimal biological dose (OBD) of PEG-BCT-100 based on the
pharmacodynamics (PD) of arginine depletion (ADD) relative to plasma PK of PEG-
BCT-100.
- To evaluate any objective tumor responses to PEG-BCT-100 in HCC patients receiving
weekly doses of PEG-BCT-100 alone and in combination with standard doses of doxorubicin
Secondary objectives of this study are:
- To define any toxicities associated with the metabolic and cellular alterations of ADD
relative to dose and PK of PEG-BCT-100 (rhArgIpeg5000).
- To develop a safe and biologically active dose and schedule for PEG-BCT-100 treatment
in phase 2 trials, either as monotherapy or in combination with best standard of care
chemotherapy.
- To confirm the safety and initial anti-tumor activity of the preferred dose and regimen
of PEG-BCT-100 in 18 additional patients with advanced HCC
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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