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An Open Label, Phase I, Dose Escalation Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Volasertib in Combination With Decitabine in Patients ≥ 65 Years With Acute Myeloid Leukemia

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Trial Profile

An Open Label, Phase I, Dose Escalation Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Volasertib in Combination With Decitabine in Patients ≥ 65 Years With Acute Myeloid Leukemia

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Volasertib (Primary) ; Decitabine
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions
  • Sponsors Boehringer Ingelheim
  • Most Recent Events

    • 01 Jan 2021 Protocol was amended to add other Schedules (B, C, and D) with reduced volasertib dose density with the aim to improve treatment tolerability.
    • 01 Jan 2021 Results published in the International Journal of Hematology
    • 14 Dec 2016 Status changed from active, no longer recruiting to discontinued.
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