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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

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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