The phase I/II , open-label, multi-center, dose escalation study (NCT03008187) of the first-in-class dual PIM/Fms like tyrosine kinase (FLT3) inhibitor, SEL24, for Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) patients has been placed on full clinical hold by the US Food and Drug Administration (FDA).1 The phase I/II study aimed to determine the maximum tolerated dose of SEL24 in R/R AML patients as well as the safety and its anti-leukemic activity.
The full clinical hold decision made by the FDA comes after Selvita, the drug manufacturers, reported a suspected serious unexpected adverse reaction of a fatal stroke in a patient enrolled in one of the cohort in the dose escalation phase of the study. The patient was administered 150 mg dose of SEL24 and received four doses, after which developed a grade 4 venous thrombus in the brain with subsequent intracerebral hemorrhage. The patient was hospitalized and died four days later due to the cerebral event. The death of the patient was evaluated and it was concluded that it could possibly be related to SEL24.1
As a result of the full clinical hold, no new patients are to be enrolled into this phase I/II trial and enrolled patients are not to be administered SEL24 until the full clinical hold is lifted by the FDA. Selvita plans to “work diligently” with the FDA in order to “seek the release of the clinical hold” and will be providing the FDA with the “requested additional data and analysis on patients treated with SEL24, as well as a proposed protocol amendment.1