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A Phase III, Multi-Center, Randomized, Controlled Study to Assess the Efficacy and Safety of ON 01910.Na Administered as a 72-Hour Continuous Intravenous Infusion Every Other Week in Myelodysplastic Syndrome Patients with Excess Blasts Relapsing After, or Refractory to, or Intolerant to Azacitidine or Decitabine

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Trial Profile

A Phase III, Multi-Center, Randomized, Controlled Study to Assess the Efficacy and Safety of ON 01910.Na Administered as a 72-Hour Continuous Intravenous Infusion Every Other Week in Myelodysplastic Syndrome Patients with Excess Blasts Relapsing After, or Refractory to, or Intolerant to Azacitidine or Decitabine

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 May 2024

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At a glance

  • Drugs Rigosertib (Primary) ; Cytarabine; Erythropoietin; Filgrastim; Hydroxycarbamide
  • Indications Myelodysplastic syndromes
  • Focus Registrational; Therapeutic Use
  • Acronyms ONTIME
  • Sponsors Onconova Therapeutics

Most Recent Events

  • 29 Jun 2020 Status changed from active, no longer recruiting to completed.
  • 04 Dec 2018 Results assessing safety and pharmacokinetics of rigosertib in patients with myelodysplastic syndromes, presented at the 60th Annual Meeting and Exposition of the American Society of Hematology.
  • 20 Jul 2018 Planned End Date changed from 1 Nov 2018 to 1 Feb 2019.

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