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

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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

Recruiting
Phase of Trial: Phase II

Latest Information Update: 19 Apr 2018

At a glance

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

    • Most Recent Events

    • 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.
    • 28 Feb 2018 Planned End Date changed from 11 Oct 2019 to 30 Jun 2022.
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