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First received: February 16, 2023

Clinical Trial: Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML)

Study Status: ACTIVE_NOT_RECRUITING

Recruit Status: ACTIVE_NOT_RECRUITING

Condition: Acute Myeloid Leukemia

Study Type: INTERVENTIONAL


Official Title: Phase 1 Dose Escalation Study of Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML)

Brief Summary: Phase 1 of the study will open first with a (Bayesian optimal interval BOIN) dose finding design.The starting dose of tomivosertib is 100mgdaily (doses 24 ± 2 hours apart), PO, self-administered with meals.The dose finding follows a BOIN design, with the 100mg BID dose level with a meal being the highest dose.There is one dose level below (dose level -1 = 100mg QD without a meal) that will be given if the de-escalation condition is met during dose finding.Upon completion of the phase 1 dose finding portion of the…

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