drugset / Trial / NCT04187898

Open-Label, Phase 1 Study to Evaluate Duration of Severe Neutropenia After Same-Day Dosing of Eflapegrastim in Patients With Breast-Cancer

NCT04187898

Phase 1 Completed 59 enrolled Spectrum Pharmaceuticals, Inc
RandomizedSequentialOpen-labelTreatment

Summary

The purpose of this study is to compare the effect of Eflapegrastim on duration of neutropenia in patients with early-stage breast cancer when administered at varying intervals following Docetaxel and Cyclophosphamide administration.

Timeline

Start
2020-03-11
Primary completion
2024-07-16
Completion
2024-08-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Eflapegrastim Protein / enzyme biologic 13.2 mg Subcutaneous
Background Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Background Docetaxel Small molecule 75 mg/m2 Intravenous