drugset / Trial / NCT01940601
Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim in Pediatric Patients With Solid Tumors
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this study is to find the optimal dose of balugrastim by characterizing its pharmacokinetics (PK), and by comparing the pharmacodynamics (PD) of balugrastim to filgrastim in children receiving chemotherapy.
Timeline
- Start
- 2014-09
- Primary completion
- 2015-11
- Completion
- 2015-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Balugrastim | Protein / enzyme biologic | 300 ug/kg | Subcutaneous |
| Subject | Balugrastim | Protein / enzyme biologic | 670 ug/kg | Subcutaneous |
| Comparator | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |