Ph 3 ADI-PEG 20 Versus Placebo in Subjects With Advanced Hepatocellular Carcinoma Who Have Failed Prior Systemic Therapy
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01287585
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 636 participants
Conditions and interventions
Conditions
Interventions
- ADI-PEG 20 (arginine deiminase formulated with polyethylene glycol) Drug
- Placebo Drug
- Best Supportive Care Other
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
- Jul 2011 (Type not available)
- Primary completion
- Jul 2015 (Actual)
- Completion
- Jul 2015 (Actual)
- Last update posted
- Sep 6, 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 6, 2019 · Synced Oct 28, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01287585 live on ClinicalTrials.gov.