Pilot Study Evaluating the Efficacy and Safety of Metformin in Melanoma
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary evaluation criteria is the response rate (response rate, RR) defined by the ratio between the total number of patients with a complete response (complete response, CR) or partial (partial response, PR) and the total number of patients in the study. Partial or complete responses will be defined by RECIST 1.1 (15) criteria : Complete response: disappearance of all targets lesions Partial response: decrease of at least 30% of the sum of the biggest diameters of each target lesion All others patients, including those for who the response couldn't be measured, will be considered non-responders.
Once time after 6 months of treatment by metformine
BAHADORAN Philippe, PHD
Service de Dermatologie - Hôpital de l'Archet - CHU de Nice
France: Agence Nationale de Sécurité du Médicament et des produits de santé