IRB #

IRB00008019

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

Principal Investigator

Gina Vaccaro

Study Purpose

"The purpose of this study is to find out if ADI-PEG 20 (the study drug) can increase overall survival time for subjects with advanced hepatocellular carcinoma (HCC). The study will also evaluate the side effects of the study drug.

Medical Condition(s)

Liver

Eligibility Criteria

* Liver Cancer (Hepatocellular Carcinoma)
* Failure on prior treatment with at least 1 chemotherapy
* Cannot be candidate for surgery

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

For as long as the treatment works and/or with no intolerable side effects.

Minors Included

No

Contact

Clinical Trials hotline: Phone 503-494-1080 or trials@ohsu.edu

Sponsor

Polaris Group

Recruitment End

Compensation Provided

No