Date: 2016-07-29
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Merck KGaA (Germany)
Product: tepotinib
Action
mechanism: tyrosine kinase inhibitor. Tepotinib is an investigational small-molecule inhibitor of the c-Met receptor tyrosine kinase that has been shown to cause growth inhibition and regression of tumors in preclinical models. Alterations of the c-Met signaling pathway are found in various cancer types and correlate with aggressive tumor behavior and poor clinical prognosis.
Disease: lung adenocarcinoma stage IIIB/IV
Therapeutic area: Cancer - Oncology
Country: Belgium, France, Germany, Italy, Poland, Spain, USA
Trial
details: This study will look at how effective tepotinib is at stopping the growth and spread of lung cancer that carries a specific genetic alteration (MET exon 14 skipping alterations) and that did not respond to standard of care treatment such as chemotherapy (platinum doublet containing regimen). This study will also measure a number of other things including safety of the study drug and the side effects, how body processes the study drug, or how the study drug affects your quality of life. The study also has an optional pharmacogenetic research part. Pharmacogenetic research is an important way to try to understand the role of genetics in human disease and how genes impact the effectiveness of drugs, because differences in genes can change the way a person responds to a particular drug. (NCT02864992)
Latest
news: * On July 29, 2015, a Phase 2 trial sponsored by Merck KGaA was published on the NIH website ClinicalTrials.gov for tepotinib and is currently recruiting participants.
