drugset / Trial / NCT02527746
Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
Non-randomizedParallel-groupOpen-labelTreatment
Summary
A Phase I, dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients who received up to 4 cycles of Epirubicin and Cyclophosphamide. 18 patients (6 patients each cohort) were assigned to three escalated dose cohorts of 80, 240 and 320 µg/kg.
Timeline
- Start
- 2012-12
- Primary completion
- 2013-12
- Completion
- 2013-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | F-627 | Protein / enzyme biologic | 80 ug/kg | Subcutaneous |
| Subject | F-627 | Protein / enzyme biologic | 240 ug/kg | Subcutaneous |
| Subject | F-627 | Protein / enzyme biologic | 320 ug/kg | Subcutaneous |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Background | Epirubicin | Small molecule | 100 mg/m2 | Intravenous |