Study of Pegylated Human Recombinant Arginase for Liver Cancer (BCT-100-002) (BCT-100-002)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01092091|
Recruitment Status : Completed
First Posted : March 24, 2010
Last Update Posted : March 14, 2012
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm Hepatocellular Carcinoma||Biological: Pegylated Recombinant Human Arginase I||Phase 1 Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Recombinant Human Arginase I (rhArgI) for Patients With Advanced Hepatocellular Carcinoma (HCC)|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
Pegylated Recombinant Human Arginase I
Biological: Pegylated Recombinant Human Arginase I
Weekly dose of PEG-BCT-100 for at least 8 weeks (or until disease progression) at 1600U/kg
Other Name: PEG-BCT-100
- Tumor response [ Time Frame: 12 weeks ]Tumor response endpoints include(a)Objective response for each patient evaluated by RECIST, (b)Modified RECIST criteria will be used as secondary reference, (c) The proportion of patients achieving a partial response or complete response (d) The proportion of patients reporting disease progression by RECIST and the times to progression (e)Serial changes in plasma AFP levels after doses of PEG-BCT-100 and (f)Change in relevant viral serology from baseline to end-of-study
- Overall Survival [ Time Frame: 12 weeks ]Overall Survival measurement from the date of starting the first dose of PEG-BCT-100 until death from any cause at every 4 weeks until the patient's death, or 3 months from the last patient's study visit, through clinical visits or telephone follow-ups
- Time to Progression [ Time Frame: 12 weeks ]
- Plasma arginase level [ Time Frame: 12 weeks ]The PK endpoints include (a) Dose-related peak to trough concentrations of plasma PEG-BCT-100 over time (b)Plasma clearance of PEG-BCT-100; and(c)Intra- and inter-subject variability of plasma PK parameters to assess the predictability of PEG-BCT-100 administration
- Quality of Life [ Time Frame: 12 weeks ]Measurement of Quality of Life by completing 2 questionnaires at baseline, week 8 and 4-weekly after week 8 until end of treatment visit. The Chinese version of the EORTC QLQ-C30 will be used, which contains Five functional scales and Three symptom scales. The Chinese version of EORTC QLQ-HCC18 will also be used.
- Plasma arginine levels [ Time Frame: 12 weeks ]The PD endpoints include (a)The magnitude of plasma arginine depletion relative to the dose (b)The duration of effective ADD assessed by plasma arginine <8 µM relative to the plasma peak and time to clearance (c) The relationships of PEG-BCT-100 dose and its resultant effective ADD to changes in AFP and/or tumor symptoms and measurements(d)The temporal and quantitative relationships of depleted plasma arginine to dose and plasma concentrations of PEG-BCT-100; and (e)Correlation of prolonged arginine depletion with extended survival
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): NCT01092091
|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|