F-627

DRUG6 trials

Sponsors

EVIVE Biotechnology

Conditions

Breast CancerNeutropenia

Phase 1

Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

CompletedNCT02527746

EVIVE BiotechnologyBreast Cancer, Neutropenia

Start: 2012-12-31End: 2013-12-31Updated: 2024-02-23

Phase 2

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

CompletedNCT01648322

EVIVE BiotechnologyBreast Cancer, Neutropenia

Start: 2012-06-30End: 2014-12-31Updated: 2018-10-03

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

CompletedNCT02521441

EVIVE BiotechnologyNeutropenia

Start: 2014-07-03End: 2015-12-22Updated: 2018-02-23

Phase 3

Placebo-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

CompletedNCT02872103

EVIVE BiotechnologyBreast Cancer, Neutropenia

Start: 2016-08-31End: 2017-12-20Updated: 2021-05-05

Neulasta-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

CompletedNCT03252431

EVIVE BiotechnologyBreast Cancer, Neutropenia

Start: 2018-04-12End: 2020-03-05Updated: 2023-07-03

Study to Compare the Efficacy and Safety of F-627 and GRAN®

CompletedNCT04174599

EVIVE BiotechnologyBreast Cancer, Neutropenia

Start: 2018-04-12End: 2019-06-19Updated: 2025-04-20

Related Papers

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.

2025-10-09

Guard-02: Safety and efficacy of prophylactic use of novel long-acting G-CSF efbemalenograstim α on same-day of chemotherapy in breast cancer patients.

Journal of Clinical Oncology2025-05-28

Abstract 800: Safety and efficacy of same-day administration of novel long-acting G-CSF efbemalenograstim α in breast cancer patients undergoing cytotoxic chemotherapy

Cancer Research2025-04-21

A randomized, multicenter phase III Study of once-per-cycle administration of efbemalenograstim alfa (F-627), a novel long-acting rhG-CSF, for prophylaxis of chemotherapy-induced neutropenia in patients with breast cancer.

2024-09-135 citations

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.

2024-01-094 citations

Efbemalenograstim alfa, an Fc fusion protein, long-acting granulocyte-colony stimulating factor for reducing the risk of febrile neutropenia following chemotherapy: results of a phase III trial

Supportive Care in Cancer2023-12-168 citations

Abstract P5-16-14: A randomized, multicenter phase III study of once-per-cycle administration of efbemalenograstim alfa (F-627), a novel long-acting dimeric rhG-CSF, for prophylaxis of chemotherapy-induced neutropenia in patients with breast cancer

Cancer Research2022-02-153 citations