A Phase 2/3, Multicenter, Randomized, Double Blind, Study to Evaluate Duration of Severe Neutropenia With Plinabulin Versus Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy (Protective 1)

Trial Profile

A Phase 2/3, Multicenter, Randomized, Double Blind, Study to Evaluate Duration of Severe Neutropenia With Plinabulin Versus Pegfilgrastim in Patients With Solid Tumors Receiving Docetaxel Myelosuppressive Chemotherapy (Protective 1)

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 09 Nov 2017

At a glance

  • Drugs Plinabulin (Primary) ; Pegfilgrastim
  • Indications Neutropenia
  • Focus Registrational; Therapeutic Use
  • Acronyms Protective-1
  • Sponsors BeyondSpring Pharmaceuticals
  • Most Recent Events

    • 09 Nov 2017 According to a BeyondSpring Pharmaceuticals media release, data from the phase 2 portion of this trial is expected in December 2017 and interim phase 3 data from this trial is expected by mid-2018.
    • 06 Jul 2017 According to a BeyondSpring Pharmaceuticals media release, the company expects reporting Phase 2 efficacy data in the second half of 2017 and Phase 3 interim data in 2018, as well as in submitting a New Drug Application (NDA) in 2019 to the FDA and CFDA.
    • 06 Jul 2017 According to a BeyondSpring Pharmaceuticals media release, the China Food and Drug Administration (CFDA) has approved the Company's Clinical Trial Applications (CTAs) to allow the initiation of the phase II/III trial of Plinabulin.
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