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
Patients will be randomized 2:1 to study drug versus placebo. Patients will be recruited
from North American, Europe and Asia. In addition to overall survival, progression free
survival, responses by RECIST 1.1 criteria and time to tumor progression will be calculated.
Safety and tolerability will be assessed, as will pharmacodynamics (peripheral blood levels
of arginine and citrulline), pharmacokinetics (peripheral blood levels of ADI-PEG 20) and
immunogenicity (antibodies to ADI-PEG 20).
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Overall survival - until death or study closure.
John S Bomalaski, M.D.
United States: Food and Drug Administration
|University of Alabama||Birmingham, Alabama|
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|
|Stanford University||Stanford, California 94305|
|University of Washington||Seattle, Washington 98195|
|University of Maryland Greenbaum Cancer Center||Baltimore, Maryland 21201|
|University of Pennsylvania Abramson Cancer Center||Philadelphia, Pennsylvania 19104|
|University of Hawaii||Honolulu, Hawaii 96813|
|Michael E. DeBakey VA Medical Center||Houston, Texas 77030|
|Drexel University||Philadelphia, Pennsylvania 19104|
|University of California at San Diego Moores Cancer Center||San Diego, California|
|Pacific Medical Center||San Francisco, California|
|Piedmont Research Institute||Atlanta, Georgia|
|Johns Hopkins University Hospital||Baltimore, Maryland|
|University of Oregon||Portland, Oregon|