A Phase III, Randomized, Multi-Centre, Double-Blind, Placebo Controlled Clinical Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
Phase of Trial: Phase III
Latest Information Update: 05 Mar 2018
At a glance
- Drugs Benegrastim (Primary)
- Indications Neutropenia
- Focus Registrational; Therapeutic Use
- Sponsors Generon (Shanghai) Corporation
- 24 Jan 2018 According to a Generon Corporation media release, This is one of two pivotal Phase III studies required for BLA submission in the US.
- 24 Jan 2018 Primary endpoint (The duration in days of grade 4 (severe) neutropenia observed in chemotherapy cycle 1 in comparison to Placebo) has been met according to a Generon Corporation media release.
- 22 Jan 2018 Status changed from active, no longer recruiting to completed.