drugset / Trial / NCT03135951

Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy

NCT03135951

Phase 1 Completed 26 enrolled Spectrum Pharmaceuticals, Inc
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the pharmacokinetic (PK) profile of a fixed dose of SPI-2012 in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (TC) chemotherapy, as measured by the serum concentration of SPI-2012 on specific days following drug administration.

Timeline

Start
2017-05-11
Primary completion
2018-02-19
Completion
2018-05-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Eflapegrastim Protein / enzyme biologic 13.2 mg Subcutaneous

Indications