Finding studies
Finding studies
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Lead
Northwestern University
With
PRIMARY OBJECTIVE: To determine the dose of maximum pharmacologic activity (MPA) of tomivosertib in relapsed/refractory AML . SECONDARY OBJECTIVES: 1. To assess the adverse event profile of tomivosertib 2. To estimate the rate of complete remission (CR) 3. To estimate the rate of overall response 4. To estimate the duration of response (DOR) 5. To estimate progression free survival (PFS) 6. To estimate overall survival (OS) 7. To assess the outcomes for patients who undergo allogeneic hematopoietic stem cell transplant (HSCT) 8. To assess the pharmacodynamics of tomivosertib by eIF4E phosphorylation before, during, and after cycle 1 treatment 9. To measure MCL1 expression before and after cycle 1 treatment 10. To assess the steady-state pharmacokinetics of tomivosertib EXPLORATORY OBJECTIVES: 1. To correlate eIF4E phosphorylation before and after cycle 1 treatment with treatment response. 2. To correlate MCL1 expression before and after treatment with treatment response.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
