A Phase 1b Dose Escalation Study Evaluating the Safety and Pharmacokinetics of Venetoclax in Combination With Azacitidine in Subjects With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

Trial Profile

A Phase 1b Dose Escalation Study Evaluating the Safety and Pharmacokinetics of Venetoclax in Combination With Azacitidine in Subjects With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

Recruiting
Phase of Trial: Phase I

Latest Information Update: 30 Sep 2017

At a glance

  • Drugs Azacitidine (Primary) ; Azacitidine (Primary) ; Venetoclax (Primary)
  • Indications Myelodysplastic syndromes
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors AbbVie
  • Most Recent Events

    • 26 Sep 2017 Phase of the trial has been changed from Phase II to Phase I; Efficacy endpoints have been removed and trial focus changed to only PK and AR; Planned number of patients changed from 90 to 44.
    • 26 Sep 2017 Planned End Date changed from 15 Sep 2019 to 12 Dec 2020.
    • 26 Sep 2017 Status changed from suspended to recruiting.
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