drugset / Trial / NCT02698189
A Dose Exploration Study With Birabresib (MK-8628) in Participants With Selected Hematologic Malignancies (MK-8628-005)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Birabresib | Small molecule | 20 mg | Oral |