Study of Pegylated Human Recombinant Arginase for Liver Cancer
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|ClinicalTrials.gov Identifier: NCT00988195|
Recruitment Status : Completed
First Posted : October 2, 2009
Last Update Posted : March 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm Hepatocellular Carcinoma||Biological: Pegylated Recombinant Human Arginase I Drug: Doxorubicin||Phase 1|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
Pegylated Recombinant Human Arginase I
Biological: Pegylated Recombinant Human Arginase I
Week 1 (Single Dose); Weeks 3 - 11 (Weekly Dose x 8 weeks)in 8 escalation doses
Other Name: PEG-BCT-100
Weeks 13-24 (once every 3 weeks)
Other Name: Adriamycin
- Plasma arginase and arginine levels,as well as tumour response, i.e. an effect on growth in the milieu of arginine depletion. [ Time Frame: 24 weeks ]
- Overall Survival, Time to Progression [ Time Frame: 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988195
|Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, The University of Hong Kong|
|Hong Kong, Hong Kong|
|Principal Investigator:||Ronnie TP Poon, Prof||Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, The University of Hong Kong|