40
Participants
Start Date
July 31, 2016
Primary Completion Date
October 31, 2018
Study Completion Date
November 30, 2018
ME-344
ME-344 is a synthetic small molecule mitochondrial inhibitor based on the isoflavan ring structure. ME-344 is a chiral compound, and is manufactured predominantly as a single stereoisomer that is dextrorotatory. As a stereoisomeric drug with two chiral centers, ME-344 is one of four potential stereoisomers. The current manufacturing process produces a racemic mixture of two of those stereoisomers, which are enantiomers, and ME-344 is separated from the levorotatory enantiomer by chromatography in the final step.
Bevacizumab
Bevacizumab is a recombinant humanized monoclonal antibody that blocks angiogenesis by inhibiting vascular endothelial growth factor A (VEGF-A)
Normal saline
Use saline as placebo
H. Arnau de Vilanova Lleida, Lleida
Hospital Ramón y Cajal, Madrid
Hospital Universitario 12 de Octubre, Madrid
Clínica Quirón, Madrid
Hospital Universitario de Fuenlabrada, Fuenlabrada
Fundacion CRIS de Investigación para Vencer el Cáncer
OTHER
Centro Nacional de Investigaciones Oncologicas CARLOS III
OTHER