A Phase 2, International, Multicenter, Randomized, Open-label, Parallel Group Study to Evaluate the Efficacy and Safety of CC-486 (oral azacitidine) Alone and in Combination with Durvalumab (MEDI4736) in Subjects With Myelodysplastic Syndromes Who Fail to Achieve an Objective Response to Treatment With Azacitidine for Injection or Decitabine

Trial Profile

A Phase 2, International, Multicenter, Randomized, Open-label, Parallel Group Study to Evaluate the Efficacy and Safety of CC-486 (oral azacitidine) Alone and in Combination with Durvalumab (MEDI4736) in Subjects With Myelodysplastic Syndromes Who Fail to Achieve an Objective Response to Treatment With Azacitidine for Injection or Decitabine

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 25 Jul 2018

At a glance

  • Drugs Azacitidine (Primary) ; Durvalumab (Primary)
  • Indications Myelodysplastic syndromes
  • Focus Therapeutic Use
  • Sponsors Celgene Corporation
  • Most Recent Events

    • 23 Jul 2018 Status changed from recruiting to active, no longer recruiting.
    • 12 Apr 2018 The combination will not be studied, hence the the durvalumab plus CC-486 combination arm is removed, study design changed.
    • 28 Feb 2018 Planned number of patients changed from 194 to 120.
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