Date: 2016-02-29
Type of information: Initiation of the trial
phase: 1
Announcement: initiation of the trial
Company: Merck&Co (USA - NJ)
Product: MK-8628 (formerly known as OTX015)
Action
mechanism: Bromodomain inhibitor. This synthetic small molecule is an inhibitor of BET bromodomain proteins 2/3/4. These proteins are considered potential cancer targets, as they play a pivotal role in regulating the transcription of growth-promoting and cell cycle regulators, especially c-MYC. MK-8628 (formerly known as OTX015) has been developed by OncoEthix a Swiss-based privately held biotechnology company specializing in oncology drug development. Merck&Co has acquired the company in December 2014.
Disease: 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).
Therapeutic area: Cancer - Oncology
Country: Canada, France, Switzerland, UK, USA
Trial
details: This is a study to determine the recommended dose of 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. (NCT02698189)
Latest
news: * On February 29, 2016, a Phase I trial sponsored by Merck&Co was published on the NIH website ClinicalTrials.gov for MK-8628 (formerly known as OTX015) and is currently recruiting participants.