Spots Global Cancer Trial Database for Ph 3 ADI-PEG 20 Versus Placebo in Subjects With Advanced Hepatocellular Carcinoma Who Have Failed Prior Systemic Therapy
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Trial Identification
Brief Title: Ph 3 ADI-PEG 20 Versus Placebo in Subjects With Advanced Hepatocellular Carcinoma Who Have Failed Prior Systemic Therapy
Official Title: A Randomized, Double-Blind, Multi-Center Phase 3 Study of ADI-PEG 20 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed Prior Systemic Therapy
Study ID: NCT01287585
Conditions
Study Description
Brief Summary: This is a study of ADI-PEG 20 (pegylated arginine deiminase), an arginine degrading enzyme versus placebo in patients with hepatocellular carcinoma who have failed prior systemic treatment (chemotherapy). Hepatocellular carcinomas have been found to require arginine, an amino acid. Thus the hypothesis is that by restricting arginine with ADI-PEG 20, the hepatocellular carcinoma cells will starve and die.
Detailed Description: Patients will be randomized 2:1 to study drug versus placebo. Patients will be recruited from North American, Europe and Asia. In addition to overall survival, progression free survival, responses by RECIST 1.1 criteria and time to tumor progression will be calculated. Safety and tolerability will be assessed, as will pharmacodynamics (peripheral blood levels of arginine and citrulline), pharmacokinetics (peripheral blood levels of ADI-PEG 20) and immunogenicity (antibodies to ADI-PEG 20).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, 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, Cheng Du, 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, Padova, , Italy
Azienda Ospedaliera San Camillo Forlanini, Roma, , Italy
Instituto Nazionale pler le Malattie Infettive, Rome, , Italy
Asan Medical Center, Seoul, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
CGMHCY, ChiaYi, , 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, , Taiwan
Northern Taiwan University Hospital, Taipei City, , Taiwan
Mackay Memorial Hospital-Taipei Branch, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou, Taoyuan County, , 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
Contact Details
Name: John S Bomalaski, M.D.
Affiliation: Polaris Group
Role: STUDY_DIRECTOR
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