1
Participants
Start Date
April 30, 2012
Primary Completion Date
May 31, 2013
Study Completion Date
May 31, 2013
Recombinant human arginase 1 Peg5000
Patients will receive weekly IV infusions of PEG-BCT-100, until evidence of disease progression, intolerable adverse events, or withdrawal of patient consent. For safety sake, each subject will receive an induction dose of PEG-BCT-100 500 U/kg and 1000 U/kg at week -2 and week -1, respectively. The study dose of PEG-BCT-100 1600 U/kg will be initiated at week 1 (Day1). Each escalation of dose level will be determined by the investigator according to each subject's tolerability and criteria for treatment discontinuation.
Department of Paediatrics and Adolescent Medicine, The University of Hong Kong, Hong Kong
Lead Sponsor
The University of Hong Kong
OTHER
Bio-Cancer Treatment International Limited
INDUSTRY