A Phase 2/3, Multicenter, Randomized Study to Evaluate Plinabulin Versus Pegfilgrastim in Reducing the Duration of Severe Neutropenia in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy With Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) (Protective 2)

Trial Profile

A Phase 2/3, Multicenter, Randomized Study to Evaluate Plinabulin Versus Pegfilgrastim in Reducing the Duration of Severe Neutropenia in Breast Cancer Patients Receiving Myelosuppressive Chemotherapy With Docetaxel, Doxorubicin, and Cyclophosphamide (TAC) (Protective 2)

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 30 Nov 2017

At a glance

  • Drugs Plinabulin (Primary) ; Cyclophosphamide; Docetaxel; Doxorubicin
  • Indications Neutropenia
  • Focus Registrational; Therapeutic Use
  • Acronyms Protective 2
  • Sponsors BeyondSpring Pharmaceuticals
  • Most Recent Events

    • 30 Nov 2017 According to a BeyondSpring Pharmaceuticals media release, the company expects to submit a New Drug Application (NDA) in 2018 to the FDA and CFDA. Also company expects to open US and European sites within the next several months.
    • 09 Nov 2017 According to a BeyondSpring Pharmaceuticals media release, interim Phase 2 data from this trial is expected by mid-2018.
    • 26 Oct 2017 Status changed from not yet recruiting to recruiting, according to a BeyondSpring Pharmaceuticals media release.
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