NCT00988195

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed
Last Updated

March 14, 2012

Status Verified

March 1, 2012

Enrollment Period

1.3 years

First QC Date

September 30, 2009

Last Update Submit

March 13, 2012

Conditions

NeoplasmHepatocellular Carcinoma

Keywords

NeoplasmHepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Plasma arginase and arginine levels,as well as tumour response, i.e. an effect on growth in the milieu of arginine depletion.

    24 weeks

Secondary Outcomes (1)

  • Overall Survival, Time to Progression

    24 weeks

Study Arms (1)

PEG-BCT-100

EXPERIMENTAL

Pegylated Recombinant Human Arginase I

Biological: Pegylated Recombinant Human Arginase IDrug: Doxorubicin

Interventions

Pegylated Recombinant Human Arginase IBIOLOGICAL

Week 1 (Single Dose); Weeks 3 - 11 (Weekly Dose x 8 weeks)in 8 escalation doses

Also known as: PEG-BCT-100
PEG-BCT-100
DoxorubicinDRUG

Weeks 13-24 (once every 3 weeks)

Also known as: Adriamycin
PEG-BCT-100

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

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

Study Sites (1)

Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Links

MeSH Terms

Conditions

NeoplasmsCarcinoma, Hepatocellular

Interventions

BCT-100Doxorubicin

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

DaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Ronnie TP Poon, Prof

    Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

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

September 30, 2009

First Posted

October 2, 2009

Study Start

May 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

March 14, 2012

Record last verified: 2012-03

Locations

HK(1)