A Phase 1 Investigator Sponsored Study of Selinexor in Combination With Daunorubicin and Cytarabine in Patients With Previously Untreated Poor-Risk Acute Myeloid Leukemia

Trial Profile

A Phase 1 Investigator Sponsored Study of Selinexor in Combination With Daunorubicin and Cytarabine in Patients With Previously Untreated Poor-Risk Acute Myeloid Leukemia

Suspended
Phase of Trial: Phase I

Latest Information Update: 31 Oct 2017

At a glance

  • Drugs Selinexor (Primary) ; Cytarabine; Daunorubicin
  • Indications Acute myeloid leukaemia; Leukaemia
  • Focus Adverse reactions
  • Most Recent Events

    • 31 Oct 2017 Some discrepancy was found in the study status. For confirmation I have sent mail to the investigator and waiting for the reply (levla.khavarian@moffitt.org).
    • 23 May 2017 Planned End Date changed from 1 Oct 2017 to 1 Mar 2018.
    • 10 Mar 2017 According to a Karyopharm Therapeutics media release, the FDA has placed selinexor (KPT-330) trials on partial clinical hold due to incomplete information in the existing version of the investigator's brochure (IB), Karyopharm has amended the IB and updated the informed consent documents accordingly and submitted to the FDA as requested.
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