drugset / Trial / NCT01560195
A Study of Pegylated rhG-CSF as Support to Advanced Non-Small-Cell Lung Cancer (NSCLC) Patients Receiving Chemotherapy Receiving Chemotherapy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |