ME-344 in Early HER2-negative Breast Cancer With Antiangiogenic-induced Mitochondrial Metabolism

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

July 31, 2016

Primary Completion Date

October 31, 2018

Study Completion Date

November 30, 2018

Conditions
Breast CancerHuman Epidermal Growth Factor 2 Negative Carcinoma of BreastEarly-Stage Breast Carcinoma
Interventions
DRUG

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.

DRUG

Bevacizumab

Bevacizumab is a recombinant humanized monoclonal antibody that blocks angiogenesis by inhibiting vascular endothelial growth factor A (VEGF-A)

OTHER

Normal saline

Use saline as placebo

Trial Locations (5)

25198

H. Arnau de Vilanova Lleida, Lleida

28034

Hospital Ramón y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28223

Clínica Quirón, Madrid

28942

Hospital Universitario de Fuenlabrada, Fuenlabrada

All Listed Sponsors
collaborator

Fundacion CRIS de Investigación para Vencer el Cáncer

OTHER

lead

Centro Nacional de Investigaciones Oncologicas CARLOS III

OTHER

NCT02806817 - ME-344 in Early HER2-negative Breast Cancer With Antiangiogenic-induced Mitochondrial Metabolism | Biotech Hunter | Biotech Hunter