A Phase I/II Study of the Selective Inhibitor of Nuclear Export Selinexor (KPT-330) in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Leukemia or Myelodysplastic Syndrome

Trial Profile

A Phase I/II Study of the Selective Inhibitor of Nuclear Export Selinexor (KPT-330) in Combination With Fludarabine and Cytarabine in Patients With Refractory or Relapsed Leukemia or Myelodysplastic Syndrome

Suspended
Phase of Trial: Phase I/II

Latest Information Update: 10 Apr 2017

At a glance

  • Drugs Cytarabine (Primary) ; Fludarabine (Primary) ; Selinexor (Primary) ; Cytarabine; Hydrocortisone; Methotrexate
  • Indications Acute myeloid leukaemia
  • Focus Therapeutic Use
  • Most Recent Events

    • 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.
    • 10 Mar 2017 Status changed from recruiting to suspended, according to a Karyopharm Therapeutics media release.
    • 09 Mar 2017 New trial record
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