A Study Comparing Pegylated Filgrastim and Filgrastim in Support for Chemotherapy

Summary

Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and delay the schedule of chemotherapy. Preventive filgrastim administration has long been established as the standard of care. A pegylated filgrastim was independently developed by GeneLeuk Biopharmaceutical Co., Ltd, Shandong, China. It composed of filgrastim and a 20 kd polyethylene glycol molecule covalently bound at the N-terminal residue. Preclinical studies phase 1 and phase 2 trials have shown that pegylated filgrastim has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with filgrastim. These characters were similar to those of Neulasta. The investigators designed a multicenter, randomized, cross-over phase Ⅲ trial to compare the efficacy and safety of a single injection of pegylated filgrastim and daily injections of filgrastim in chemotherapy naive patients receiving commonly used regimens. The hypothesis is that pegylated filgrastim is similarly effective and safe with regular filgrastim.

Timeline

Start

2006-01

Primary completion

2007-05

Completion

2008-12

Publications

• Yang S, He X, Liu P, Zhou S, Dong M, Qin Y, Yang J, Zhang C, Han X, Shi Y. [Duration of filgrastim prophylaxis for chemotherapy-induced neutropenia and its predictors]. Zhonghua Zhong Liu Za Zhi. 2016 Jan;38(1):69-72. doi: 10.3760/cma.j.issn.0253-3766.2016.01.013. Chinese.

Drugs

Indications