Trials / Terminated
TerminatedNCT02698189
A Dose Exploration Study With Birabresib (MK-8628) in Participants With Selected Hematologic Malignancies (MK-8628-005)
A Phase IB Trial With MK-8628, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Subjects With Selected Hematologic Malignancies
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 9 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Birabresib Dose 20 mg | Administered as an oral capsule twice a day for 21 consecutive days per cycle. |
Timeline
- Start date
- 2016-05-19
- Primary completion
- 2018-01-18
- Completion
- 2021-09-09
- First posted
- 2016-03-03
- Last updated
- 2022-09-13
- Results posted
- 2019-07-23
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02698189. Inclusion in this directory is not an endorsement.