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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT01287585

Public ClinicalTrials.gov record NCT01287585. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 6, 2026, 8:54 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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 identification

NCT ID
NCT01287585
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Polaris Group
Industry
Enrollment
636 participants

Conditions and interventions

Interventions

  • ADI-PEG 20 (arginine deiminase formulated with polyethylene glycol) Drug
  • Best Supportive Care Other
  • Placebo Drug

Drug · Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 30, 2011
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015
Last update posted
Sep 5, 2019

2011 – 2015

United States locations

U.S. sites
21
U.S. states
13
U.S. cities
19
Facility City State ZIP Site status
University of Alabama Birmingham Alabama
Southern California Research Center Coronado California 92118
Catherine Frenette La Jolla California 92037
Stanford University Palo Alto California
University of California at San Diego Moores Cancer Center San Diego California
Pacific Medical Center San Francisco California
Piedmont Research Institute Atlanta Georgia
University of Hawaii Honolulu Hawaii
University of Maryland Greenbaum Cancer Center Baltimore Maryland 21201
Johns Hopkins University Hospital Baltimore Maryland
Wayne State University School of Medicine, Dept Oncology Detroit Michigan 48201
University of Minnesota Cancer Center Minneapolis Minnesota
Nebraska Hem-Onc Lincoln Nebraska
Memorial Sloan-Kettering Cancer Center New York New York 10065
University of Oregon Portland Oregon
Drexel University Philadelphia Pennsylvania
University of Pennsylvania Abramson Cancer Center Philadelphia Pennsylvania
UPMC Cancer Centers Pittsburgh Pennsylvania
UT Southwestern Dallas Texas
Michael E. DeBakey VA Medical Center Houston Texas
University of Washington Seattle Washington

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 52 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01287585, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 5, 2019 · Synced May 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01287585 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →