drugset / Trial / NCT02698189

A Dose Exploration Study With Birabresib (MK-8628) in Participants With Selected Hematologic Malignancies (MK-8628-005)

NCT02698189 ↗

Phase 1 Terminated 9 enrolled Merck Sharp & Dohme LLC
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a study to determine the recommended dose of birabresib (MK-8628) for further studies in participants with acute myeloid leukemia (AML) including AML de novo and AML secondary to myelodysplastic syndrome (MDS) and in participants with diffuse large B cell lymphoma (DLBCL). The recommended dose will be established by evaluating dose limiting toxicity (DLT), safety, tolerability, and early efficacy signals.

Timeline

Start
2016-05-19
Primary completion
2018-01-18
Completion
2021-09-09

Outcome

Outcome not reported

Stopped: “This study was terminated due to limited efficacy and not due to safety reasons”

Drugs

EvaluationDrugModalityDoseRoute
Subject Birabresib Small molecule 20 mg Oral