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

Completed · Phase 3 · Has a placebo group

Conditions studied: Hepatocellular Carcinoma

In brief

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.

Key facts

Study ID

NCT01287585

Run by

Polaris Group

People needed

636

Starts

2011-07-01

Expected to finish

2015-07-01

Last updated by the study team

2019-09-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prior diagnosis of HCC confirmed histologically.
• Prior treatment with at least 1 systemic agent, with documented progressive disease after systemic agent(s), or adverse event(s)associated with prior systemic agent(s) that resulted in discontinuance of that agent(s).
• Cirrhotic status of Child-Pugh grade B7.
• Expected survival of at least 3 months.
• Adequate hematologic, hepatic, and renal function.

You may not qualify if…

• Candidate for potential curative therapies (i.e., resection or transplantation) or loco-regional approaches (i.e., ablation, embolization).
• Significant cardiac disease.
• Serious infection requiring treatment with systemically administered antibiotics.
• Pregnancy or lactation.
• Expected non-compliance.
• Uncontrolled intercurrent illness, or psychiatric illness or social situations that would limit compliance with study requirements.
• Subjects who have had any anticancer treatment within 2 weeks prior to entering the study.
• Subjects who have not fully recovered from toxicities associated with previous HCC loco-regional or systemic therapies.
• Subjects with history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor with no known active disease present in the opinion of the investigator will not affect patient outcome in the setting of current HCC diagnosis.
• Allergy to pegylated products.
• Bleeding esophageal or gastric varices within the prior three months, except if banded or treated.
• Subjects known to be HIV positive.
• Uncontrolled ascites (defined as not easily controlled with diuretic treatment).
• Having received any blood transfusion, blood component preparation, erythropoietin, albumin preparation, or granulocyte colony stimulating factors (G-CSF) within 7 days prior to screening laboratories or after screening laboratories have been obtained until first dose of study drug or placebo.
• Use of traditional medicines approved by local authorities, including but not limited to Chinese herbs within 14 days of first dose of study drug or placebo.
• ECOG performance status > 2.
• Prior allograft,including liver transplant.

Where it is running

• 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 Municipality, China
• University of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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