A Phase II, Dose-finding Study of F-627 in Patients With Breast Cancer Receiving Myelotoxic Chemotherapy.

Summary

This was a randomized, open-label, active-controlled, dose-finding, phase II study to evaluate the efficacy and safety of 2 doses of F-627 compared to Filgrastim in women with breast cancer receiving myelotoxic chemotherapy. Subjects would be randomized to one of three arms, which were 10 mg/dose of F-627, 20 mg/dose of F-627 or Filgrastim, in an equal ratio.

Timeline

Start

2014-07-03

Primary completion

2015-09-20

Completion

2015-12-22

Publications

• Ji D, Wang S, Yao W, Hou D, Wang X, Ye C, Li H, Yang H, Yi J, Lu J, Wang H, Xu X, Cai D, Liu X, Yan X, Nie J, Cui S, Jiang H, Cao J. Efbemalenograstim Alfa, an Fc Fusion Protein, Long-Acting Granulocyte Colony-Stimulating Factor for Reducing the Risk of Chemotherapy-Induced Neutropenia: Results of a Phase II Randomized, Multicenter, Open-Label Trial. Clin Drug Investig. 2025 Nov;45(11):889-899. doi: 10.1007/s40261-025-01479-y. Epub 2025 Oct 9.

Drugs

Indications