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

NCT01287585 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 636

Last updated 2019-09-06

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Polaris Group

    lead INDUSTRY

Principal Investigators

  • John S Bomalaski, M.D. · Polaris Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States
  • China
  • Italy
  • South Korea
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01287585 on ClinicalTrials.gov