drugset / Trial / NCT01840007

Pilot Study Evaluating the Efficacy and Safety of Metformin in Melanoma

NCT01840007 ↗

Phase 2 Completed 20 enrolled Centre Hospitalier Universitaire de Nice
NaSingle-groupOpen-labelTreatment

Summary

In western countries, melanoma represents a major mistake of public health by its frequency, lethality and the increasing of incidence. Surgery can cure melanoma diagnosed very early. In other cases, it exists a risk of recurrence of lymph node and visceral. At the stage of visceral metastases, the prognosis of melanoma is catastrophic, with a median survival of 6 months. Indeed, the reference chemotherapy by dacarbazine induces a very limited response rate of 10-20%, the ipilimumab which has been authorized in the second intention, has a response rate of 10%, and other available treatments don't have a superior efficiency. Metformin is an oral antidiabetic of biguanides family which acts by inducing the activation of AMPK, a molecule which is inactivated in many cancers including the melanoma. In agreement with these data, several preclinical studies suggested that metformin has antineoplastic activity. In the case of melanoma, a study published recently has showed that metformin inhibits proliferation of melanoma cells in vitro and we confirmed for our part these results in our laboratory (INSERM U895).

Timeline

Start
2011-08-30
Primary completion
2015-05-28
Completion
2015-11-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 2540 mg Oral

Indications