- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01092091
Study of Pegylated Human Recombinant Arginase for Liver Cancer (BCT-100-002) (BCT-100-002)
March 13, 2012 updated by: Bio-Cancer Treatment International Limited
Recombinant Human Arginase I (rhArgI) for Patients With Advanced Hepatocellular Carcinoma (HCC)
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, Hong Kong
- Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, The University of Hong Kong
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Confirmed diagnosis of HCC according to the European Association for the Study of the Liver criteria
- Known underlying HCC etiology specified by hepatitis B, hepatitis C, post alcoholic cirrhosis, or other
- HCC lesion(s) which are not resectable and which are measurable by C-T scan
- Progression of or non-response of HCC lesions after treatments which are considered best standard of care - surgical resection, radiofrequency ablation, chemoembolization
- No cancer treatment or surgery within the prior 4 weeks, either chemotherapy, targeted biologic or enzymes, either approved or investigational;
- Males or females from 18 to 75 years-old, inclusive;
- Ability and willingness to provide written informed consent;
- Karnofsky performance status of 80% or above and expected survival of more than 12 weeks; and,
- Negative urine pregnancy test, if female, and willingness to use an effective method of contraception during the entire study period
- No cognitive impairment
- Ability to understand and read Chinese
Exclusion Criteria:
- Advancing liver failure indicated by uncontrolled ascites, pleural effusions, encephalopathy, or a Child-Pugh score of C
- Significant hepatic, renal or bone marrow dysfunction indicated by total bilirubin >40 µmol/L, evidence of bile duct obstruction, serum albumin <30 g/L, serum SGOT >5 x upper limit of normal, ANC <1.0 x 10^9/L, platelets <100 x 10^9/L, or INR >2.0
- Significant cardiac or pulmonary disease defined by New York Heart Association (NYHA) Class III or IV, VEF <50% by echo or MUGA, or a history of myocardial infarction within the past 6 months, significant unstable arrhythmia or evidence of ischemia on ECG
- Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Significant active infection including HIV requiring oral or parenteral anti-infective therapies;
- Use of investigational drug(s) within 4 weeks of enrollment; or,
- Prior treatment with arginine depleting agent.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PEG-BCT-100
Pegylated Recombinant Human Arginase I
|
Weekly dose of PEG-BCT-100 for at least 8 weeks (or until disease progression) at 1600U/kg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12 weeks
|
Time to Progression
Time Frame: 12 weeks
|
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
|
12 weeks
|
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.
|
12 weeks
|
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
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
February 1, 2012
Study Registration Dates
First Submitted
March 23, 2010
First Submitted That Met QC Criteria
March 23, 2010
First Posted (Estimate)
March 24, 2010
Study Record Updates
Last Update Posted (Estimate)
March 14, 2012
Last Update Submitted That Met QC Criteria
March 13, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HKCTR-503C
- PR/CT0299/2009 (Other Identifier: Department of Health, HKSAR)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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