Phase 3 Study of ADI-PEG 20 in Patients with Hepatocellular Carcinoma
Research type
Research Study
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
IRAS ID
77657
Contact name
David Propper
Sponsor organisation
Polaris Group
Eudract number
2011-002041-36
Clinicaltrials.gov Identifier
Research summary
Primary liver cancer, hepatocellular carcinoma (HCC) is one of the most common malignancies in the world. The Polaris Group is conducting a phase 3 clinical study on the study drug ADI-PEG 20. ADI-PEG 20 causes a nutrient called arginine (an amino acid) to break down. Normal cells do not require arginine however, liver cancer cells seem to need arginine to survive. The Polaris Group is using ADI-PEG 20 as a way to starve liver cancer cells and stop them from growing. The purpose of this study is to see what effects the study drug ADI-PEG 20 has on the participant and their liver cancer (HCC). We would like to find out more information about tumour shrinkage, whether people might live longer and how safe the drug is in participants taking the study drug ADI-PEG 20. We are also interested in knowing if tumour growth is slowed down by this drug. Up to approximately 600 participants will take part in this study worldwide. Approximately 50 participants will take part in the UK. Around 400 participants will be treated with ADI-PEG 20, and around 200 participants will be treated with placebo (a dummy drug).Participation will involve a total of 13 weeks or longer depending on the number of treatments the participant completes. Tumour scans will be performed every 12 weeks and if they show that the participants tumour is not growing, they may continue to receive additional cycles of ADI-PEG 20 or placebo until their tumour grows larger, their tumour goes away or unless they have serious side effects. The study involves the following procedures: physical examination, vital signs, ECG, CT (or MRI) scans, blood tests and a tumour tissue test on an existing tumour sample.
REC name
London - South East Research Ethics Committee
REC reference
11/LO/1369
Date of REC Opinion
15 Nov 2011
REC opinion
Further Information Favourable Opinion