A Study Comparing Pegylated Filgrastim and Filgrastim in Support for Chemotherapy
Status:
Completed
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
Chinese Academy of Medical Sciences
Collaborators:
Beijing Chest Hospital Changhai Hospital First Hospital of China Medical University Fudan University Fujian Cancer Hospital Hospital affiliated to Academy of Military Medical Sciences Hunan Cancer Hospital Peking University Third Hospital Qilu Hospital Qilu Hospital of Shandong University The Second Affiliated Hospital of Dalian Medical University Tianjin Medical University Cancer Tianjin People's Hospital West China Hospital Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Zhejiang Cancer Hospital