Ph 3 ADI-PEG 20 Versus Placebo in Subjects With Advanced Hepatocellular Carcinoma Who Have Failed Prior Systemic Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

636

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

July 31, 2015

Study Completion Date

July 31, 2015

Conditions
Hepatocellular Carcinoma
Interventions
DRUG

ADI-PEG 20 (arginine deiminase formulated with polyethylene glycol)

18 mg/m2, weekly, intramuscular, until disease progression or toxicity.

DRUG

Placebo

weekly, intramuscular, until disease progression or toxicity.

OTHER

Best Supportive Care

treatment of disease-related symptoms throughout the study.

Trial Locations (73)

10065

Memorial Sloan-Kettering Cancer Center, New York

21201

University of Maryland Greenbaum Cancer Center, Baltimore

40447

China Medicine University Hospital, Taichung

48201

Wayne State University School of Medicine, Dept Oncology, Detroit

92037

Catherine Frenette, La Jolla

92118

Southern California Research Center, Coronado

100071

5th Fl, Inpatient Bldg, No. 8,, Fengtai Distrcit

116011

5th Floor, Medical Building, No. 1018 Huguang Rd, Changchun

No. 193, Lianhe Rd, Shahekou Dist., Dalian

150040

3rd Floor, Medicine Building, No. 150 Haping Rd, Harbin

213003

Oncology, 185 Road Juqian Street, Changzhou

230601

Oncology, No. 678, Furong Rd, Hefei

233000

A ward of Oncology-287 Changhuai Rd, Bengbu

350025

No. 156 North Road of West Second Ring, Gulou District

400038

13th Floor, Internal Medicine Building, No. 29 Gaotanyan Main St., Chongqing

510060

15th Floor, In-patient Building (East), No. 651 Dongfeng East Road, Guangzhou

530021

5th Fl, Inpatient Bldg, No. 71, Heti Rd, Qingxiu Disttrict

610041

Floor 7, 3rd Inpatient Building No. 37, Guoxue Xiang, Chengdu

710038

No. 596, Xinsi Rd., Baqiao Dist., Xi'an

Unknown

University of Alabama, Birmingham

Stanford University, Palo Alto

University of California at San Diego Moores Cancer Center, San Diego

Pacific Medical Center, San Francisco

Piedmont Research Institute, Atlanta

University of Hawaii, Honolulu

Johns Hopkins University Hospital, Baltimore

University of Minnesota Cancer Center, Minneapolis

Nebraska Hem-Onc, Lincoln

University of Oregon, Portland

Drexel University, Philadelphia

University of Pennsylvania Abramson Cancer Center, Philadelphia

UPMC Cancer Centers, Pittsburgh

UT Southwestern, Dallas

Michael E. DeBakey VA Medical Center, Houston

University of Washington, Seattle

The First Hospital of Medical University Of Anhui, Hefei

The Chinese people's liberation army 81 hospital, Nanjing

Bldg No. 5, 3rd Floor, Dongan Rd, Shanghai

"Istituto Tumori Giovanni Paolo II", Bari

Policlinico S. Orsola-Malpighi, Bologna

Azienda Ospedaliera Niguarda Cà Granda, Milan

Fondazione Centro San Raffaele del Monte Tabor, Milan

"Fondazione IRCCs Ca Granda Ospedale Maggiore Policlinico", Milan

Policlinico di Monza, Monza

Istituto Nazionale per lo Studio e la Cura dei Tumori, Naples

Azienda Ospedaliera di Padova, Padua

Azienda Ospedaliera San Camillo Forlanini, Roma

Instituto Nazionale pler le Malattie Infettive, Rome

Asan Medical Center, Seoul

Korea University Anam Hospital, Seoul

Samsung Medical Center, Seoul

Seoul St. Mary's Hospital, Seoul

Severance Hospital, Seoul

CGMHCY, Chiayi City

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

Chang Gung Medical Foundation-Kaohsiung, Kaohsiung County

CMMC-LY, Tainan City

CMMC-YK, Tainan City

National Cheng Kung University Hospital, Tainan City

Mackay Memorial Hospital-Taipei Branch, Taipei

Northern Taiwan University Hospital, Taipei

Taipei Veterans General Hospital, Taipei

Chang Gung Medical Foundation-Linkou, Taoyuan

Clatterbridge Cancer Center, Bebington

University Hospitals Birmingham NHS Foundation Trust, Birmingham

Hammersmith Hospital, London

King's College Hospital, London

Royal Free Hospital, London

St. Bartholomew's Hospital, London

The Royal Marsden Hospital, London

Christie NHS Trust, Manchester

Nottingham University Hospital, Nottingham

Royal Marsden, Sutton

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Polaris Group

INDUSTRY