Approval Probability
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Birabresib · 1 trial · 6 indications
A DLT was defined as any of the following toxicities that were considered by the investigator to be related to MK-8628: Hematologic toxicity: Grade 4 hematologic toxicity or febrile neutropenia, Grade 3 neutropenia with infection, Grade 3 thrombocytopenia with bleeding or lasting \>7 days; Non-hematologic toxicity: Grade 3 or 4 non-hematologic toxicity (regardless of duration) unless it was not optimally managed with supportive care, Grade 3 or 4 laboratory abnormality, with or without symptoms, lasting \>48 hours, Intolerable Grade 2 non-hematologic toxicity resulting in study drug discontinuation or delay \>7 days with or without dose reduction, Designated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) liver test abnormalities; Treatment delay \>2 weeks or dose reduction requirement for initiating Cycle 2.
| Arm | Type | Description |
|---|---|---|
| Continuous Dosing Regimen | EXPERIMENTAL | Participants receive birabresib capsules once daily in a fasted state in the morning on Days 1-21 of each 21-day cycle. Starting dose for dose escalation is 80 mg. |
| Days 1-7 Dosing Regimen | EXPERIMENTAL | Participants receive birabresib capsules once daily in a fasted state in the morning on Days 1-7 of each 21-day cycle. Starting dose for dose escalation is 100 mg. |
| Name | Type | Description |
|---|---|---|
| Birabresib | DRUG | Birabresib 10, 20 and/or 40 mg oral capsules |
Inclusion Criteria: 1. Signed informed consent obtained prior to initiation of any study-specific procedures and treatment; 2. Histologically or cytologically confirmed diagnosis of one of the following advanced or metastatic solid tumors for which standard therapy either does not exist or has prov...
Birabresib is an investigational small molecule being studied for the treatment of NUT Midline Carcinoma, a rare and aggressive cancer. It is also being evaluated in other advanced solid tumors, including triple negative breast cancer, non-small cell lung cancer with ALK rearrangement or KRAS mutation, castrate-resistant prostate cancer, and pancreatic ductal adenocarcinoma.
Birabresib targets bromodomain and extra-terminal (BET) proteins. It is a small molecule inhibitor of these proteins, which play a role in regulating gene expression that can drive tumor growth. By inhibiting BET proteins, Birabresib aims to disrupt cancer cell proliferation.
Birabresib is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is also known as MK-8628.
Birabresib is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to evaluate its safety and efficacy.
Birabresib has been studied in one completed Phase 1 clinical trial, identified as NCT02259114. This dose-finding study enrolled 47 adults with selected advanced solid tumors, including NUT Midline Carcinoma, and was designed to evaluate the safety and tolerability of the drug.
Yes, Birabresib is also known as MK-8628. The clinical trial NCT02259114, titled 'A Dose-Finding Study of Birabresib (MK-8628), a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, in Adults With Selected Advanced Solid Tumors,' uses both names to refer to the same drug.