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.

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.

Planning
Phase of Trial: Phase III

Latest Information Update: 27 Mar 2017

At a glance

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

    • 27 Mar 2017 The protocol for this trial is expected to be ready for submission to the EMA and the FDA for a Special Protocol Assessment during the second or third quarter of 2017, according to an Onconova Therapeutics media release.
    • 07 Oct 2016 New trial record
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