Status:
COMPLETED
Pilot Study Evaluating the Efficacy and Safety of Metformin in Melanoma
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Metastatic Melanoma (Stage IIIC Non-résécable or no Surgically Curable or Stage IV With Classification AJCC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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, ...
Eligibility Criteria
Inclusion
- Major patients with metastatic melanoma (stage IIIC non-résécable or no surgically curable or stage IV with classification AJCC) in progression after a first-line of treatment by vemurafenib or chemotherapy, and non-eligible or non-responders to ipilimumab.
- Metastases measurable by RECIST criteria. Hematologic, renal and hepatic appropriate functions. Negative pregnancy test.
Exclusion
- Patients with symptomatic brain metastases and Performans Status (PS)\>2. Patients with carcinomatous meningitis. Pregnant or breathfeeding women. Patients with a contraindication to the metformine. HIV infection, active infection with HBV or HCV. Patients already treated with metformin in the context of diabetes.
Key Trial Info
Start Date :
August 30 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01840007
Start Date
August 30 2011
End Date
November 18 2015
Last Update
November 29 2022
Active Locations (2)
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1
Bahadoran
Nice, Alpes-Maritimes, France, 06200
2
MORTIER Laurent
Lille, Nord, France, 59000