A Phase II study of the safety and efficacy of PEG-BCT-100 combined with capecitabine/oxaliplatin in patients with advanced hepatocellular carcinoma (Part I)

Professor Yau, Chung Cheung Thomas   (Project Coordinator (PC))

Dr Cheng Paul   (Co-Investigator)

24

2014-04-15

2661353

A Phase II study of the safety and efficacy of PEG-BCT-100 combined with capecitabine/oxaliplatin in patients with advanced hepatocellular carcinoma (Part I)

advanced hepatocellular carcinoma, capecitabine/oxaliplatin in patients, PEG-BCT-100 combined

Others - Medicine, Dentistry and Health

UIM/257

Matching Grant for Joint Research

2013

Completed

Pegylated recombinant human arginase (PEG-BCT-100) is an investigational new drug developed by BCT for the treatment of arginine reliant human malignancies. Previously it has been gone through extensive pre-clinical pharmacology-toxicology and CMC studies and passed the stringent IND requirements set by US FDA. Recently the phase I/II clinical trials of PEG-BCT-100 in patient with advanced hepatocellular carcinoma has been completed in Hong Kong, suggesting its clinical safety and preliminary efficacy in humans. A phase 2, open label, 2 parts study of PEG-BCT-100 in combination with capecitabine and oxaliplatin (PACOX regimen) in patients with locally advanced or metastatic HCC will be conducted, starting with Part 1 for determination of the maximum tolerated dose (MTD) of oxaliplatin in combination with capecitabine and PEG-BCT-100. Part 2 will test the recommended dose of PACOX regimen as determined in Part 1. The whole study will evaluate the safety and efficacy of PACOX regimen. To fit in the ITF project timeline requirement, the current application is applied to Part 1 only. It is anticipated that Part 1will recruited 9-18 patients for determination of the MTD of oxaliplatin and receiving the PACOX regimen until disease progression or withdrawal. The anticipated average number of PACOX cycles received by each subject is six.