Phase I Investigator Sponsored Study to Assess the Tolerability and Efficacy of Selinexor in Combination With High Dose Cytarabine (HiDAC) and Mitoxantrone Chemotherapy for Remission Induction in Acute Myelogenous Leukemia (AML)

Trial Profile

Phase I Investigator Sponsored Study to Assess the Tolerability and Efficacy of Selinexor in Combination With High Dose Cytarabine (HiDAC) and Mitoxantrone Chemotherapy for Remission Induction in Acute Myelogenous Leukemia (AML)

Suspended
Phase of Trial: Phase I

Latest Information Update: 28 Jul 2017

At a glance

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

    • 28 Jul 2017 Last checked against ClinicalTrials.gov.
    • 10 Mar 2017 Status changed from recruiting to suspended, according to a Karyopharm Therapeutics media release
    • 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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