Study of Pegylated Human Recombinant Arginase for Liver Cancer (BCT-100-002)
BCT-100-002
Recombinant Human Arginase I (rhArgI) for Patients With Advanced Hepatocellular Carcinoma (HCC)
2 other identifiers
interventional
20
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 23, 2010
CompletedFirst Posted
Study publicly available on registry
March 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2012
CompletedMarch 14, 2012
March 1, 2012
1.9 years
March 23, 2010
March 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tumor response
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 Outcomes (5)
Overall Survival
12 weeks
Time to Progression
12 weeks
Plasma arginase level
12 weeks
Quality of Life
12 weeks
Plasma arginine levels
12 weeks
Study Arms (1)
PEG-BCT-100
EXPERIMENTALPegylated Recombinant Human Arginase I
Interventions
Weekly dose of PEG-BCT-100 for at least 8 weeks (or until disease progression) at 1600U/kg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bio-Cancer Treatment International Limitedlead
- The University of Hong Kongcollaborator
- Chinese University of Hong Kongcollaborator
Study Sites (1)
Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, The University of Hong Kong
Hong Kong, Hong Kong
Related Publications (1)
Chan SL, Cheng PNM, Liu AM, Chan LL, Li L, Chu CM, Chong CCN, Lau YM, Yeo W, Ng KKC, Yu SCH, Mok TSK, Chan AWH. A phase II clinical study on the efficacy and predictive biomarker of pegylated recombinant arginase on hepatocellular carcinoma. Invest New Drugs. 2021 Oct;39(5):1375-1382. doi: 10.1007/s10637-021-01111-8. Epub 2021 Apr 15.
PMID: 33856599DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronnie TP Poon, Prof
Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, The University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2010
First Posted
March 24, 2010
Study Start
March 1, 2010
Primary Completion
February 1, 2012
Study Completion
February 1, 2012
Last Updated
March 14, 2012
Record last verified: 2012-03