Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
20
1 country
2
Study Start
August 30, 2011
Actual (reported)Primary Completion
May 28, 2015
Actual (reported)Study Completion
November 18, 2015
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 18, 2015
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 30, 2011
Actual (reported)April 23, 2013
Actual (reported)April 25, 2013
Actual (reported)May 28, 2015
Actual (reported)November 18, 2015
Actual (reported)Response rate
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
the overall survival, the survival without progress (PFS), the tolerance, and the quality of life.
6 times
The chosen posology is 2540 mg/day of metformin-base so 3 tablets/day of Glucophage ® 1000. Patients should take 3 tablets/day at the rate of 1tablet in morning, noon and evening to favor the absorbtion and reduce the risk of gastrointestinal intolerance. In case of missed dose, patients will be allowed to take 2 tablets on the next grip. The drug will be presented in its officinale form of Glucophage ® 1000 with specifications indicated in the Vidal dictionary. It will be provided each month, to patient, 3 boxes of 30 tablets of Glucophage ® 1000. The patient will be asked to rate each day, on a calendar, the number of tablets of Glucophage ® 1000 effectively taken. It will also ask to the patient to bring back used boxes of Glucophage ® 1000 to count any tablets not taken.
The chosen posology is 2540 mg/day of metformin-base so 3 tablets/day of Glucophage ® 1000. Patients should take 3 tablets/day at the rate of 1tablet in morning, noon and evening to favor the absorbtion and reduce the risk of gastrointestinal intolerance. In case of missed dose, patients will be allowed to take 2 tablets on the next grip. The drug will be presented in its officinale form of Glucophage ® 1000 with specifications indicated in the Vidal dictionary. It will be provided each month, to patient, 3 boxes of 30 tablets of Glucophage ® 1000. The patient will be asked to rate each day, on a calendar, the number of tablets of Glucophage ® 1000 effectively taken. It will also ask to the patient to bring back used boxes of Glucophage ® 1000 to count any tablets not taken.
Bahadoran
Nice, Alpes-Maritimes, 06200, France
MORTIER Laurent
Lille, Nord, 59000, France
Montaudie H, Cerezo M, Bahadoran P, Roger C, Passeron T, Machet L, Arnault JP, Verneuil L, Maubec E, Aubin F, Granel F, Giacchero D, Hofman V, Lacour JP, Maryline A, Ballotti R, Rocchi S. Metformin monotherapy in melanoma: a pilot, open-label, prospective, and multicentric study indicates no benefit. Pigment Cell Melanoma Res. 2017 May;30(3):378-380. doi: 10.1111/pcmr.12576. Epub 2017 Apr 22. No abstract available.
BAHADORAN Philippe, PHD
Service de Dermatologie - Hôpital de l'Archet - CHU de Nice
20 participants (actual enrollment reported by the registry).
First Submitted
April 23, 2013
First Posted
April 25, 2013
Study Start
August 30, 2011
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
May 28, 2015
Actual (reported)Study Completion
November 18, 2015
Actual (reported)Last Updated
March 31, 2026
Record last verified: 2013-02
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