drugset / Trial / NCT03559387
Randomized Phase 2, Dose-finding Efficacy, Safety Study of ANF-RHO™ Versus Neulasta® in Chemotherapy-Induced Neutropenia
RandomizedParallel-groupOpen-labelTreatment
Summary
Randomized, Open-Label study to determine the dose, efficacy, safety and pharmacokinetic profile of ANF-RHO™ with once-per-cycle injection in comparison with Neulasta in Breast Cancer patients at high risk of developing Chemotherapy-Induced Neutropenia
Timeline
- Start
- 2017-08-03
- Primary completion
- 2018-04-18
- Completion
- 2018-05-22
Outcome
Outcome not reported
Stopped: “Study redesign”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ANF-Rho | Protein / enzyme biologic | 10 ug/kg | Subcutaneous |
| Subject | ANF-Rho | Protein / enzyme biologic | 20 ug/kg | Subcutaneous |
| Subject | ANF-Rho | Protein / enzyme biologic | 30 ug/kg | Subcutaneous |
| Comparator | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |