Ph 3 ADI-PEG 20 Versus Placebo in Subjects With Advanced Hepatocellular Carcinoma Who Have Failed Prior Systemic Therapy
NCT ID: NCT01287585
Last Updated: 2019-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
636 participants
INTERVENTIONAL
2011-07-31
2015-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ADI-PEG 20
Arginine deiminase formulated with polyethylene glycol.
ADI-PEG 20 (arginine deiminase formulated with polyethylene glycol)
18 mg/m2, weekly, intramuscular, until disease progression or toxicity.
Best Supportive Care
treatment of disease-related symptoms throughout the study.
Placebo
an inert treatment with no therapeutic value.
Placebo
weekly, intramuscular, until disease progression or toxicity.
Best Supportive Care
treatment of disease-related symptoms throughout the study.
Interventions
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ADI-PEG 20 (arginine deiminase formulated with polyethylene glycol)
18 mg/m2, weekly, intramuscular, until disease progression or toxicity.
Placebo
weekly, intramuscular, until disease progression or toxicity.
Best Supportive Care
treatment of disease-related symptoms throughout the study.
Eligibility Criteria
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Inclusion Criteria
* Prior treatment with at least 1 systemic agent, with documented progressive disease after systemic agent(s), or adverse event(s)associated with prior systemic agent(s) that resulted in discontinuance of that agent(s).
* Cirrhotic status of Child-Pugh grade B7.
* Expected survival of at least 3 months.
* Adequate hematologic, hepatic, and renal function.
Exclusion Criteria
* Significant cardiac disease.
* Serious infection requiring treatment with systemically administered antibiotics.
* Pregnancy or lactation.
* Expected non-compliance.
* Uncontrolled intercurrent illness, or psychiatric illness or social situations that would limit compliance with study requirements.
* Subjects who have had any anticancer treatment within 2 weeks prior to entering the study.
* Subjects who have not fully recovered from toxicities associated with previous HCC loco-regional or systemic therapies.
* Subjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current HCC diagnosis.
* Allergy to pegylated products.
* Bleeding esophageal or gastric varices within the prior three months, except if banded or treated.
* Subjects known to be HIV positive.
* Uncontrolled ascites (defined as not easily controlled with diuretic treatment).
* Having received any blood transfusion, blood component preparation, erythropoietin, albumin preparation, or granulocyte colony stimulating factors (G-CSF) within 7 days prior to screening laboratories or after screening laboratories have been obtained until first dose of study drug or placebo.
* Use of traditional medicines approved by local authorities, including but not limited to Chinese herbs within 14 days of first dose of study drug or placebo.
* ECOG performance status \> 2.
* Prior allograft,including liver transplant.
18 Years
ALL
No
Sponsors
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Polaris Group
INDUSTRY
Responsible Party
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Principal Investigators
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John S Bomalaski, M.D.
Role: STUDY_DIRECTOR
Polaris Group
Locations
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University of Alabama
Birmingham, Alabama, United States
Southern California Research Center
Coronado, California, United States
Catherine Frenette
La Jolla, California, United States
Stanford University
Palo Alto, California, United States
University of California at San Diego Moores Cancer Center
San Diego, California, United States
Pacific Medical Center
San Francisco, California, United States
Piedmont Research Institute
Atlanta, Georgia, United States
University of Hawaii
Honolulu, Hawaii, United States
University of Maryland Greenbaum Cancer Center
Baltimore, Maryland, United States
Johns Hopkins University Hospital
Baltimore, Maryland, United States
Wayne State University School of Medicine, Dept Oncology
Detroit, Michigan, United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States
Nebraska Hem-Onc
Lincoln, Nebraska, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
University of Oregon
Portland, Oregon, United States
Drexel University
Philadelphia, Pennsylvania, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States
UT Southwestern
Dallas, Texas, United States
Michael E. DeBakey VA Medical Center
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
A ward of Oncology-287 Changhuai Rd
Bengbu, Anhui, China
Oncology, No. 678, Furong Rd
Hefei, Anhui, China
The First Hospital of Medical University Of Anhui
Hefei, Anhui, China
5th Fl, Inpatient Bldg, No. 8,
Fengtai Distrcit, Beijing Municipality, China
No. 156 North Road of West Second Ring
Gulou District, Fujian, China
15th Floor, In-patient Building (East), No. 651 Dongfeng East Road
Guangzhou, Guangdong, China
5th Fl, Inpatient Bldg, No. 71, Heti Rd
Qingxiu Disttrict, Guangxi, China
3rd Floor, Medicine Building, No. 150 Haping Rd
Harbin, Heilongjiang, China
Oncology, 185 Road Juqian Street
Changzhou, Jiangsu, China
The Chinese people's liberation army 81 hospital
Nanjing, Jiangsu, China
5th Floor, Medical Building, No. 1018 Huguang Rd
Changchun, Jilin, China
No. 193, Lianhe Rd, Shahekou Dist.
Dalian, Liaoning, China
No. 596, Xinsi Rd., Baqiao Dist.
Xi'an, Shaanxi, China
Floor 7, 3rd Inpatient Building No. 37, Guoxue Xiang
Chengdu, Sichuan, China
13th Floor, Internal Medicine Building, No. 29 Gaotanyan Main St.
Chongqing, , China
Bldg No. 5, 3rd Floor, Dongan Rd
Shanghai, , China
Istituto Tumori "Giovanni Paolo II"
Bari, , Italy
Policlinico S. Orsola-Malpighi
Bologna, , Italy
Azienda Ospedaliera Niguarda Cà Granda
Milan, , Italy
Fondazione Centro San Raffaele del Monte Tabor
Milan, , Italy
Fondazione IRCCs "Ca Granda" Ospedale Maggiore Policlinico
Milan, , Italy
Policlinico di Monza
Monza, , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Azienda Ospedaliera San Camillo Forlanini
Roma, , Italy
Instituto Nazionale pler le Malattie Infettive
Rome, , Italy
Asan Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul St. Mary's Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
CGMHCY
Chiayi City, , Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Chang Gung Medical Foundation-Kaohsiung
Kaohsiung County, , Taiwan
China Medicine University Hospital
Taichung, , Taiwan
CMMC-LY
Tainan City, , Taiwan
CMMC-YK
Tainan City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
Mackay Memorial Hospital-Taipei Branch
Taipei, , Taiwan
Northern Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou
Taoyuan, , Taiwan
Clatterbridge Cancer Center
Bebington, , United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
St. Bartholomew's Hospital
London, , United Kingdom
The Royal Marsden Hospital
London, , United Kingdom
Christie NHS Trust
Manchester, , United Kingdom
Nottingham University Hospital
Nottingham, , United Kingdom
Royal Marsden
Sutton, , United Kingdom
Countries
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References
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Abou-Alfa GK, Qin S, Ryoo BY, Lu SN, Yen CJ, Feng YH, Lim HY, Izzo F, Colombo M, Sarker D, Bolondi L, Vaccaro G, Harris WP, Chen Z, Hubner RA, Meyer T, Sun W, Harding JJ, Hollywood EM, Ma J, Wan PJ, Ly M, Bomalaski J, Johnston A, Lin CC, Chao Y, Chen LT. Phase III randomized study of second line ADI-PEG 20 plus best supportive care versus placebo plus best supportive care in patients with advanced hepatocellular carcinoma. Ann Oncol. 2018 Jun 1;29(6):1402-1408. doi: 10.1093/annonc/mdy101.
Other Identifiers
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POLARIS2009-001
Identifier Type: -
Identifier Source: org_study_id
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