A Phase I/II Trial of Vemurafenib and Metformin to Unresectable Stage IIIC and Stage IV BRAF.V600E+ Melanoma Patients
This is a Phase I/II study. Phase I will be evaluating the safety of the FDA-approved
Vemurafenib (960 mg orally, daily) in combination with Metformin (500 mg orally, twice daily
for 2 weeks, then 850 mg orally,twice daily) in patients with unresectable Stage IIIC and
Stage IV melanoma. Phase II will evaluate the clinical activity of the combined
Vemurafenib/Metformin regimen. The safety profile of this combined Vemurafenib/Metformin
regimen will be monitored during both phases. The treatment period consists of 28-day cycles
until progression or unacceptable toxicity occurs.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Observation of CTCAE grade 4 or higher adverse events in six patients
In the phase I portion, six patients will be enrolled and observed for CTCAE grade 4 or higher events. If three or more grade 4 or higher adverse events are observed among the six patients, the study will be halted.
Duration of phase I portion, approximately six months
Jason A Chesney, MD PhD
James Graham Brown Cancer Center-U of Louisville
United States: Institutional Review Board
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