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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
James Graham Brown Cancer Center-Universityof Louisville
Louisville, Kentucky, United States
James Graham Brown Cancer Center
Louisville, Kentucky, United States
Observation of two CTCAE drug related grade 4 toxicities in six patients.
During phase I, six patients will be enrolled and monitored for toxicities. If drug related deaths occur or more than two drug related CTCAE grade 4 toxicities occur the trial will be suspended. Phase II will estimate the efficacy of the drugs, enrolling 20 patients during stage 1 with an upper limit of 39 for the 2nd stage.
Time frame: Duration of phase I portion, approxiately 6 months
Clinical Response Rate
Phase II will study the efficacy of the drugs enrolling 20 patients during stage I with an upper limit of 39 for the 2nd stage.
Time frame: 6 years
To estimate the overall survival rates.
Patients will be contacted every 3 months following treatment administration for up to three years to obtain survival data.
Time frame: Approximately 3 years
To explore the effect of other covariates on overall survival
To identify demographic, disease and treatment related effects on overall survival.
Time frame: 3 years
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