drugset / Trial / NCT00497809
Safety and Efficacy Study of GCSF Therapy to Treat Patients at High Risk for Chemotherapy Induced Severe Neutropenia
RandomizedParallel-groupOpen-labelTreatment
Summary
The overall purpose of this study is to assess the dose response, efficacy, and safety of three different dose levels of AVI 014 (granulocyte colony-stimulating factor \[G-CSF\]) in breast cancer patients at high (\>20%) risk for chemotherapy-induced severe neutropenia.
Timeline
- Start
- 2007-08
- Primary completion
- 2008-07
- Completion
- 2009-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AVI-014 | Protein / enzyme biologic | 2.5 ug/kg | — |
| Subject | AVI-014 | Protein / enzyme biologic | 5 ug/kg | — |
| Subject | AVI-014 | Protein / enzyme biologic | 10 ug/kg | — |
| Subject | filgrastim | Protein / enzyme biologic | 5 ug/kg | — |