drugset / Trial / NCT01637493
Pharmacokinetics and Pharmacodynamics Study of Pegfilgrastim in Chemotherapy Patients
Phase 1
Unknown
24 enrolled
Hangzhou Jiuyuan Gene Engineering Co. Ltd.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to examine the safety,tolerability,pharmacokinetics and pharmacodynamics of Pegfilgrastim in patients with chemotherapy-induced neutropenia.
Timeline
- Start
- 2012-02
- Primary completion
- 2013-02
- Completion
- 2013-06
Publications
- Background Roskos LK, Lum P, Lockbaum P, Schwab G, Yang BB. Pharmacokinetic/pharmacodynamic modeling of pegfilgrastim in healthy subjects. J Clin Pharmacol. 2006 Jul;46(7):747-57. doi: 10.1177/0091270006288731.
- Background Johnston E, Crawford J, Blackwell S, Bjurstrom T, Lockbaum P, Roskos L, Yang BB, Gardner S, Miller-Messana MA, Shoemaker D, Garst J, Schwab G. Randomized, dose-escalation study of SD/01 compared with daily filgrastim in patients receiving chemotherapy. J Clin Oncol. 2000 Jul;18(13):2522-8. doi: 10.1200/JCO.2000.18.13.2522.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegfilgrastim | Protein / enzyme biologic | 30 ug/kg | Subcutaneous |
| Subject | Pegfilgrastim | Protein / enzyme biologic | 60 ug/kg | Subcutaneous |
| Subject | Pegfilgrastim | Protein / enzyme biologic | 100 ug/kg | Subcutaneous |
| Subject | Pegfilgrastim | Protein / enzyme biologic | 200 ug/kg | Subcutaneous |