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Clinical Trial Summary

The main purpose is to evaluate the clinical response, safety and survival of the FDA approved drugs Dabrafenib, Trametinib in combination with Metformin. Investigators hypothesize that the combination of an FDA approved non toxic dose of oral Metformin with the B-Raf inhibitor, Dabrafenib and the MEK inhibitor, Trametinib will yield little toxicity and improve clinical outcomes in terms of objective response rates and survival in metastatic melanoma patients.


Clinical Trial Description

The study will be a single-arm, single center, uncontrolled phase I/II trial to estimate the safety of the combined treatments and then estimate the efficacy in terms of objective response rate in patients with stage IIIC and Stage IV melanoma treated with dabrafenib/trametinib and metformin. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02143050
Study type Interventional
Source University of Louisville
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date September 2014
Completion date November 17, 2017

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