drugset

drugset / Trial / NCT01092091

Study of Pegylated Human Recombinant Arginase for Liver Cancer (BCT-100-002)

NCT01092091 ↗

Phase 1/2 Completed 20 enrolled Bio-Cancer Treatment International Limited Chinese University of Hong Kong · collab The University of Hong Kong · collab

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether recombinant human arginase (PEG-BCT-100) is safe and effective in the treatment of advanced hepatocellular carcinoma (HCC).

Timeline

Start: 2010-03
Primary completion: 2012-02
Completion: 2012-02

Publications

Chan SL, Cheng PNM, Liu AM, Chan LL, Li L, Chu CM, Chong CCN, Lau YM, Yeo W, Ng KKC, Yu SCH, Mok TSK, Chan AWH. A phase II clinical study on the efficacy and predictive biomarker of pegylated recombinant arginase on hepatocellular carcinoma. Invest New Drugs. 2021 Oct;39(5):1375-1382. doi: 10.1007/s10637-021-01111-8. Epub 2021 Apr 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pegylated Recombinant Human Arginase I	Protein / enzyme biologic	2.7 mg/kg	Intravenous
Subject	Pegylated Recombinant Human Arginase I	Protein / enzyme biologic	1600 iu/kg	Intravenous

Indications