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Pilot Study Evaluating the Efficacy and Safety of Metformin in Melanoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Metastatic Melanoma (Stage IIIC Non-résécable or no Surgically Curable or Stage IV With Classification AJCC)

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Trial Information

Pilot Study Evaluating the Efficacy and Safety of Metformin in Melanoma


Inclusion Criteria:



- 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Description:

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.

Outcome Time Frame:

Once time after 6 months of treatment by metformine

Safety Issue:

No

Principal Investigator

BAHADORAN Philippe, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Service de Dermatologie - Hôpital de l'Archet - CHU de Nice

Authority:

France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:

10-PP-17

NCT ID:

NCT01840007

Start Date:

August 2011

Completion Date:

February 2014

Related Keywords:

  • Metastatic Melanoma (Stage IIIC Non-résécable or no Surgically Curable or Stage IV With Classification AJCC)
  • Melanoma

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