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.
Disease: advanced nuclear protein in testis (NUT) midline carcinoma (NMC), triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), or castration-resistant prostate cancer (CRPC)
Therapeutic area: Cancer - Oncology
Country: Belgium, Canada, France, Spain, Switzerland, USA
Trial
details: The objective of this study is to determine the recommended dose of MK-8628 (formerly known as OTX015) for further studies in participants with advanced nuclear protein in testis (NUT) midline carcinoma (NMC), triple negative breast cancer (TNBC), non-small cell lung cancer (NSCLC), or castration-resistant prostate cancer (CRPC). The recommended dose will be established by evaluating dose limiting toxicity (DLT), safety, discontinuation, and early efficacy. (NCT02698176)
Latest
news: * On February 29, 2016, a Phase I trial sponsored by Merck&Co was published on the NIH website ClinicalTrials.gov for AMG 176 and is currently recruiting participants.