drugset
drugset / Trial / NCT04496999

HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt.

NCT04496999 ↗

Phase 1 Terminated 2 enrolled Insel Gruppe AG, University Hospital Bern
NaSingle-groupOpen-labelTreatment

Summary

This is a non-randomized prospective open-label single-arm clinical phase I trial investigating dose finding, feasibility and safety of the combined treatment of HDM201 and midostaurin in patients with relapsed/refractory acute myeloid leukemia (AML) with FLT3mut applying an accelerated titration design.

Timeline

Start
2020-07-13
Primary completion
2022-09-09
Completion
2022-09-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Midostaurin Small molecule 50 mg —
Subject Siremadlin Small molecule 40 mg —
Subject Siremadlin Small molecule 60 mg —
Subject Siremadlin Small molecule 80 mg —

Indications

acute myeloid leukemia