A Two-Stage, Open-Label Followed by Placebo-Controlled Phase 2 Study of Pracinostat and Azacitidine in Patients With IPSS-R High and Very High Risk Myelodysplastic Syndromes Previously Untreated With Hypomethylating Agents

Trial Profile

A Two-Stage, Open-Label Followed by Placebo-Controlled Phase 2 Study of Pracinostat and Azacitidine in Patients With IPSS-R High and Very High Risk Myelodysplastic Syndromes Previously Untreated With Hypomethylating Agents

Recruiting
Phase of Trial: Phase II

Latest Information Update: 15 Jun 2018

At a glance

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

    • 31 May 2018 According to a MEI Pharma media release, Based on the positive interim analysis announced today, Helsinn and MEI are expanding open-label enrollment to a total of up to 60 MDS patients. The goal of this expanded cohort is to gain an estimate of the response rate and overall survival in this patient population to better inform the design of a global registration study.
    • 31 May 2018 According to a MEI Pharma media release, company announced that a planned interim analysis in this study successfully met a predefined patient retention threshold. The positive outcome supports continuation of the study.
    • 08 Nov 2017 According to a MEI Pharma media release, data from the first stage is expected in the first half of 2018.
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