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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: 08 Feb 2019

At a glance

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

    • 30 Jan 2019 Planned End Date changed from 18 Apr 2019 to 18 Apr 2020.
    • 30 Jan 2019 Planned primary completion date changed from 1 Oct 2018 to 15 Jan 2020.
    • 06 Dec 2018 According to a BeyondSpring Pharmaceuticals media release, based on the results from Phase 3 portion of Study 105 and the data from the phase 2 portion of Study 106, the company has the necessary data to submit a new drug application (NDA) to the China Food and Drug Administration (China FDA) or National Medical Products Administration (NMPA), for the use of Plinabulin for the treatment of chemotherapy-induced neutropenia (CIN).
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