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: 09 Nov 2017

At a glance

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

    • 09 Nov 2017 According to an Onconova Therapeutics media release, the company has designed the protocol of this trial. The company is awaiting the results of a Phase Phase 1/2 Expansion Trial (see profile 236134) before proceeding further for this trial. The also plans to submit protocol to the FDA in the first half of 2018 to initiate the SPA process with the FDA.
    • 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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