An Open Phase I/IIa Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Intraveneous BI 6727 as Monotherapy or in Combination With Subcutaneous Cytarabine in Patients With Acute Myeloid Leukaemia.

Trial Profile

An Open Phase I/IIa Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Intraveneous BI 6727 as Monotherapy or in Combination With Subcutaneous Cytarabine in Patients With Acute Myeloid Leukaemia.

Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 31 Aug 2017

At a glance

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

    • 25 Aug 2017 Planned End Date changed from 11 Jul 2017 to 11 Jan 2018.
    • 19 Jun 2017 Data from this and other two trials NCT01721876 and NCT01662505 was used to develop a population model characterising the pharmacokinetic profiles of volasertib and cytarabine were published in the Clinical Pharmacokinetics.
    • 08 Jun 2017 Planned End Date changed from 1 Jun 2017 to 11 Jul 2017.
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