drugset / Trial / NCT04190550

Testing the Addition of an Anti-cancer Drug, Navtemadlin, to the Usual Treatments (Cytarabine and Idarubicin) in Patients With Acute Myeloid Leukemia

NCT04190550

Phase 1 Active not recruiting 24 enrolled National Cancer Institute (NCI)
NaSingle-groupOpen-labelTreatment

Summary

This phase Ib trial studies the side effects and best dose of navtemadlin when given together with the standard chemotherapy drugs cytarabine and idarubicin in patients with acute myeloid leukemia. Navtemadlin may stop the growth of cancer cells by blocking a protein called MDM2 that is needed for cell growth. Chemotherapy drugs, such as cytarabine and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving navtemadlin with cytarabine and idarubicin may stabilize cancer for longer when compared to giving usual treatments alone.

Timeline

Start
2021-02-04
Primary completion
2027-06-30
Completion
2027-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule Intravenous
Subject Idarubicin Small molecule Intravenous
Subject Navtemadlin Small molecule Oral