Dose-Finding Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

Phase 2 Completed 232 enrolled EVIVE Biotechnology

RandomizedSingle-groupOpen-labelTreatment

Summary

This is a randomized open label dose finding study to evaluate the efficacy and safety of F-627 on women with Stage I-IV breast cancer receiving chemotherapy treatment.

Timeline

Start: 2012-06
Primary completion: 2014-12
Completion: 2014-12

Publications

Glaspy J, Bondarenko I, Krasnozhon D, Rutty D, Chen J, Fu Y, Wang S, Hou Q, Li S. Efbemalenograstim alfa not inferior to pegfilgrastim in providing neutrophil support in women with breast cancer undergoing myelotoxic chemotherapy: results of a phase 2 randomized, multicenter, open-label trial. Support Care Cancer. 2024 Jan 9;32(2):91. doi: 10.1007/s00520-023-08260-x.

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
Comparator	Pegfilgrastim	Protein / enzyme biologic	6 mg	—

Dose-Finding Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

Summary

Timeline

Publications

Drugs

Indications