A phase IB, open-label study to determine the safety and pharmacokinetics of twice daily oral dosing of PKC412 [midostaurin]administered in combinations sequentially and concomitantly with daunorubicin and cytarabine for standard induction therapy, and high dose cytarabine for consolidation in patients with acute myeloid leukemia (AML).

Trial Profile

A phase IB, open-label study to determine the safety and pharmacokinetics of twice daily oral dosing of PKC412 [midostaurin]administered in combinations sequentially and concomitantly with daunorubicin and cytarabine for standard induction therapy, and high dose cytarabine for consolidation in patients with acute myeloid leukemia (AML).

Completed
Phase of Trial: Phase I

Latest Information Update: 23 Mar 2015

At a glance

  • Drugs Midostaurin (Primary) ; Cytarabine; Daunorubicin
  • Indications Acute myeloid leukaemia
  • Focus Pharmacokinetics; Therapeutic Use
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 05 Jun 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 24 Dec 2009 Planned number of patients changed from 52 to 70 as reported by M.D. Anderson Cancer Center.
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