Tomivosertib in Relapsed or Refractory Acute Myeloid Leukemia (AML)
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 study, the recommended starting dose of tomivosertib for the subsequent combination with the other agents will be determined, as described in Section 4.3 and Section 8.0. Tomivosertib will be dosed continuously on days 1-28 of each 28-day cycle at the dose level assigned for that cohort.
Timeline
- Start
- 2023-09-29
- Primary completion
- 2024-07-29
- Completion
- 2024-08-20
Outcome
Outcome not reported
Stopped: “Premature withdrawal of investigational product per study sponsor.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tomivosertib | Small molecule | 100 mg | Oral |