drugset / Trial / NCT01560195

A Study of Pegylated rhG-CSF as Support to Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy Receiving Chemotherapy

NCT01560195 ↗

Phase 3 Unknown 150 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b and phase 2 trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with filgrastim. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with advanced NSCLC.

Timeline

Start
2012-04
Primary completion
2013-01
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject Pegylated rhG-CSF Protein / enzyme biologic 100 ug/kg —
Subject Pegylated rhG-CSF Protein / enzyme biologic 6 mg —
Comparator rhG-CSF Protein / enzyme biologic 5 ug/kg —