drugset
drugset / Trial / NCT03404726

A Study to Investigate BAY2402234, a Dihydroorotate Dehydrogenase (DHODH) Inhibitor, in Myeloid Malignancies

NCT03404726 ↗

Phase 1 Terminated 40 enrolled Bayer
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The primary objective is to determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD), or pharmacological active dose (PAD) of BAY2402234 in patients with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or chronic myelomonocytic leukemia (CMML). The secondary objective is to evaluate evidence of clinical efficacy associated with BAY2402234 in patients with AML (defined as Complete remission, Complete remission with partial hematologic recovery), and MDS (defined as hematological improvement).

Timeline

Start
2018-03-29
Primary completion
2021-01-26
Completion
2021-01-26

Outcome

Outcome not reported

Stopped: “Lack of sufficient clinical benefit”

Drugs

EvaluationDrugModalityDoseRoute
Subject BAY2402234 Small molecule — Oral

Indications

leukemia