Second phase II/III registrational trial (106) of Plinabulin in combination with a myelosuppresive chemotherapeutic regimen composed of three agents, TAC, in patients with solid tumors

Trial Profile

Second phase II/III registrational trial (106) of Plinabulin in combination with a myelosuppresive chemotherapeutic regimen composed of three agents, TAC, in patients with solid tumors

Planning
Phase of Trial: Phase II/III

Latest Information Update: 21 Aug 2017

At a glance

  • Drugs Plinabulin (Primary) ; Cyclophosphamide; Docetaxel; Doxorubicin
  • Indications Solid tumours
  • Focus Registrational; Therapeutic Use
  • Most Recent Events

    • 21 Aug 2017 According to a BeyondSpring Pharmaceuticals media release, the company has received US FDA approval to initiate this trial.
    • 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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