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A randomized, controlled pivotal Phase 3 clinical trial comparing the combination of oral rigosertib plus azacitidine to azacitidine plus placebo in high risk myelodysplastic syndrome patients

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Trial Profile

A randomized, controlled pivotal Phase 3 clinical trial comparing the combination of oral rigosertib plus azacitidine to azacitidine plus placebo in high risk myelodysplastic syndrome patients

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 19 Apr 2024

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At a glance

  • Drugs Azacitidine (Primary) ; Azacitidine (Primary) ; Rigosertib (Primary)
  • Indications Myelodysplastic syndromes
  • Focus Registrational; Therapeutic Use
  • Sponsors Onconova Therapeutics; Traws Pharma
  • Most Recent Events

    • 02 Apr 2024 According to a Onconova Therapeutics media release, Trawsfynydd Therapeutics has merged with Onconova Therapeutics to form Traws Pharma
    • 06 Nov 2019 Trial design data of this trial was released in the 61st Annual Meeting and Exposition of the American Society of Hematology.
    • 24 Oct 2019 According to an Onconova Therapeutics media release, company plan to consult with key opinion leaders on the design the study for submission to the FDA as the next step in the development of oral rigosertib. The proposed study does not require a Special Protocol Assessment (SPA).
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