A Phase 2 Randomized Double-Blind Placebo-Controlled Study of Pracinostat in Combination With Azacitidine in Patients With Previously Untreated International Prognostic Scoring System (IPSS) Intermediate Risk-2 or High-Risk Myelodysplastic Syndrome (MDS)

Trial Profile

A Phase 2 Randomized Double-Blind Placebo-Controlled Study of Pracinostat in Combination With Azacitidine in Patients With Previously Untreated International Prognostic Scoring System (IPSS) Intermediate Risk-2 or High-Risk Myelodysplastic Syndrome (MDS)

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 26 Apr 2017

At a glance

  • Drugs Pracinostat (Primary) ; Azacitidine; Azacitidine
  • Indications Myelodysplastic syndromes
  • Focus Therapeutic Use
  • Sponsors Helsinn Healthcare SA; MEI Pharma
  • Most Recent Events

    • 21 Apr 2017 Planned End Date changed from 1 Mar 2017 to 1 Dec 2017.
    • 21 Apr 2017 Planned primary completion date changed from 1 Mar 2017 to 1 Dec 2017.
    • 17 Jan 2017 Primary endpoint has not been met. (Estimate efficacy [ Time Frame: 6 months ] [ Designated as safety issue: No ]), as per the results published in the Cancer.
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