NCT01287585

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 636 (actual)
• Sponsor: Polaris Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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).

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-07-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2011-02-01
• Last updated: 2019-09-06

Locations

73 sites across 6 countries: United States, China, Italy, South Korea, Taiwan, United Kingdom