Therapy Detail
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| Therapy Name | Birabresib |
| Synonyms | |
| Therapy Description |
Birabresib (OTX015) is an inhibitor of the BET bromodomain proteins BRD3, BRD4, and BRD5, which inhibits interaction with acetylated histone H4, potentially resulting in decreased tumor cell proliferation (Mol Cancer Ther Nov 2013 12:C244, PMID: 29733771, PMID: 31204545). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Birabresib | Y-803|MK-8628|OTX015|OTX-015 | BET Inhibitor (Pan) 32 | Birabresib (OTX015) is an inhibitor of the BET bromodomain proteins BRD3, BRD4, and BRD5, which inhibits interaction with acetylated histone H4, potentially resulting in decreased tumor cell proliferation (Mol Cancer Ther Nov 2013 12:C244, PMID: 29733771, PMID: 31204545). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| FBXW7 W425R | adult T-cell leukemia/lymphoma | resistant | Birabresib | Preclinical - Cell culture | Actionable | In a preclinical study, adult T cell leukemia cells expressing FBXW7 W425R demonstrated resistance to treatment with Birabresib (OTX015) in culture (PMID: 32907612). | 32907612 |
| FBXW7 H468R | adult T-cell leukemia/lymphoma | resistant | Birabresib | Preclinical - Cell culture | Actionable | In a preclinical study, adult T cell leukemia cells expressing FBXW7 H468R were resistant to treatment with Birabresib (OTX015) in culture (PMID: 32907612). | 32907612 |
| FBXW7 S462P | adult T-cell leukemia/lymphoma | resistant | Birabresib | Preclinical - Cell culture | Actionable | In a preclinical study, adult T cell leukemia cells expressing FBXW7 S462P were resistant to treatment with Birabresib (OTX015) in culture (PMID: 32907612). | 32907612 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02698189 | Phase I | Birabresib | A Dose Exploration Study With MK-8628 in Participants With Selected Hematologic Malignancies (MK-8628-005) | Terminated | 0 | |
| NCT02259114 | Phase I | Birabresib | A Phase IB Trial With OTX015, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Patients With Selected Advanced Solid Tumors | Completed | 0 | |
| NCT02698176 | Phase I | Birabresib | A Dose Exploration Study With MK-8628 in Participants With Selected Advanced Solid Tumors (MK-8628-006) | Terminated | 0 |
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