A Phase III, Randomized, Multi-Centre, Double-Blind, Placebo Controlled Clinical Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

Trial Profile

A Phase III, Randomized, Multi-Centre, Double-Blind, Placebo Controlled Clinical Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

Completed
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
  • Most Recent Events

    • 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.
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