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Also known as MK-8628
OTX015/Birabresib · 1 trial · 4 indications
A DLT was graded using the National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.02 and defined as any of the following: grade 3 or 4 non-hematologic adverse events unless they were not optimally treated with supportive care; grade 3 or 4 asymptomatic laboratory abnormal values lasting \>7 days; prolonged grade 2 toxicity (lasting more than 2 weeks) leading to treatment interruption and/or dose reduction; pancytopenia with a hypocellular bone marrow and no marrow blasts lasting ≥6 weeks (AL participants); grade 3 neutropenia with fever or infection (OHM participants); grade 3 thrombocytopenia with bleeding (OHM participants); or grade 4 neutropenia or thrombocytopenia, regardless of symptoms and lasting ≥3 days (OHM participants).
| Arm | Type | Description |
|---|---|---|
| AL 10 mg QD 14-21 | EXPERIMENTAL | Participants received 10 mg birabresib/OTX015 administered orally (PO), once daily (QD), in a fasted state on Days 1 to 14 of a 21-day cycle. |
| AL 20 mg QD 14-21 | EXPERIMENTAL | Participants received 20 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle. |
| AL 40 mg QD 14-21 | EXPERIMENTAL | Participants received 40 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle. |
| AL 20 mg BID 21-21 | EXPERIMENTAL | Participants received 20 mg birabresib/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle. |
| AL 80 mg QD 14-21 | EXPERIMENTAL | Participants received 80 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle. |
| AL 40 mg BID 14-21 | EXPERIMENTAL | Participants received 40 mg birabresib/OTX015 administered PO, twice a day (BID), with the first daily dose in a fasted state, on Days 1 to 14 of a 21-day cycle. |
| AL 120 mg QD 14-21 | EXPERIMENTAL | Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle. |
| AL 120 mg QD 21-21 | EXPERIMENTAL | Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle. |
| AL 160 mg QD 14-21 | EXPERIMENTAL | Participants received 160 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle. |
| AML de novo 80 mg QD 14-21 | EXPERIMENTAL | Participants received 80 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle. |
| AML/MDS 80 mg QD 14-21 | EXPERIMENTAL | Participants received 80 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle. |
| OHM 10 mg QD 21-21 | EXPERIMENTAL | Participants received 10 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle. |
| OHM 20 mg QD 21-21 | EXPERIMENTAL | Participants received 20 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle. |
| OHM 40 mg QD 21-21 | EXPERIMENTAL | Participants received 40 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle. |
| OHM 80 mg QD 21-21 | EXPERIMENTAL | Participants received 80 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle. |
| OHM 40 mg BID 21-21 | EXPERIMENTAL | Participants received 40 mg birabresib/OTX015 administered PO, BID, with the first daily dose in a fasted state, on Days 1 to 21 of a 21-day cycle. |
| OHM 120 mg QD 21-21 | EXPERIMENTAL | Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 21 of a 21-day cycle. |
| OHM 120 mg QD 14-21 | EXPERIMENTAL | Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle. |
| OHM 120 mg QD 5-7 | EXPERIMENTAL | Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 5 of a 7-day cycle. |
| OHM 120 mg QD 7-21 | EXPERIMENTAL | Participants received 120 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 7 of a 21-day cycle |
| OHM/DLBCL 80 mg QD 14-21 | EXPERIMENTAL | Participants received 80 mg birabresib/OTX015 administered PO, QD, in a fasted state on Days 1 to 14 of a 21-day cycle. |
| Name | Type | Description |
|---|---|---|
| OTX015/Birabresib | DRUG | OTX015/Birabresib 10 mg, 20 mg, or 40 mg capsules administered orally |
Inclusion Criteria: * Histologically or cytologically proven acute leukemias (AML or ALL) or hematologic malignancies (DLBCL or MM) using standard diagnosis criteria. Acute leukemia includes de novo and secondary to a pre-existing myelodysplastic syndrome, according to the World Health Organization...
OTX015, also known as Birabresib or MK-8628, is an investigational small molecule developed by Merck & Company, Inc. (MRK). It is being studied in oncology, specifically for hematologic malignancies including acute myeloid leukemia. It remains in clinical development and is not an approved therapy.
OTX015/Birabresib is being evaluated as a treatment for acute myeloid leukemia and other hematologic malignancies. It is an investigational agent and has not been approved for any indication. Its development in acute myeloid leukemia has been studied in a Phase 1 dose-finding trial.
OTX015/Birabresib is developed by Merck & Company, Inc., which trades under the ticker MRK. The drug is also known as MK-8628, reflecting Merck's internal compound designation. Merck conducted the clinical development program for this asset.
OTX015/Birabresib is in Phase 1 clinical development. The only registered trial, NCT01713582, was a Phase 1 dose-finding study that has been completed. The drug is investigational and has not received FDA approval for any indication.
OTX015/Birabresib has been studied in one clinical trial, NCT01713582, titled A Dose-finding Study of the Bromodomain (Brd) Inhibitor OTX015/Birabresib (MK-8628) in Hematologic Malignancies. This completed Phase 1 trial enrolled 141 participants and evaluated acute myeloid leukemia, diffuse large B-cell lymphoma, acute lymphoblastic leukemia, and multiple myeloma.
Yes, OTX015 and Birabresib refer to the same investigational drug, which is also known as MK-8628. These names are used interchangeably in scientific literature and clinical trial records. The compound is a small molecule developed by Merck & Company, Inc. for hematologic malignancies.