A Phase III Study of ADI-PEG20/Supportive Care or Placebo/Supportive Care in Patients with Advanced Liver Cancer

Protocol
11-081
Full 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
Phase
III
Purpose

The purpose of this study is to assess the effectiveness of an investigational drug called ADI-PEG20 in patients with advanced hepatocellular carcinoma (liver cancer) that has not responded to systemic therapy. In prior studies, some patients have experienced tumor shrinkage and have lived longer than anticipated.

ADI-PEG20 causes a nutrient called arginine to break down. Liver cancer cells require arginine to survive. By depriving liver cancer cells of arginine, ADI-PEG20 may prevent them from growing. This is complemented by the lack of a replenishing mechanism of arginine in liver cancer cells compared to normal cells.

In this study, patients will be randomly assigned in a 2:1 fashion to receive ADI-PEG20 plus best supportive care, or a placebo plus best supportive care.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of liver cancer that has stopped responding to systemic therapy, or patients must have been intolerant to systemic therapy.
  • At least 2 weeks must have passed since completion of prior therapy and entry into the study.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Ghassan Abou-Alfa at 646-888-4184.

Disease(s)
Hepatobiliary: Liver Cancer
Locations
Related Diseases