Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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/Birabresib is an investigational small molecule being studied for the treatment of Acute Myeloid Leukemia. It is also being evaluated in other hematologic malignancies including Diffuse Large B-cell Lymphoma, Acute Lymphoblastic Leukemia, and Multiple Myeloma. The drug is in Phase 1 clinical development and is not yet approved.
OTX015/Birabresib is a bromodomain (BRD) inhibitor. It targets bromodomain proteins, which are involved in regulating gene expression. By inhibiting these proteins, the drug aims to disrupt cancer cell growth and survival. This mechanism is being studied in the context of hematologic malignancies.
OTX015/Birabresib is being developed by Merck & Company, Inc., which trades under the ticker MRK. The drug is currently in Phase 1 clinical development as an investigational therapy for Acute Myeloid Leukemia and other hematologic malignancies.
OTX015/Birabresib is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is no longer in active clinical trials according to available data.
OTX015/Birabresib has been studied in one clinical trial, identified as NCT01713582. This was a Phase 1 dose-finding study in hematologic malignancies, including Acute Myeloid Leukemia, Diffuse Large B-cell Lymphoma, Acute Lymphoblastic Leukemia, and Multiple Myeloma. The trial enrolled 141 participants and has been completed.
Yes, OTX015/Birabresib is also known as MK-8628. The clinical trial NCT01713582, titled 'A Dose-finding Study of the Bromodomain (Brd) Inhibitor OTX015/Birabresib (MK-8628) in Hematologic Malignancies,' uses both names to refer to the same drug.