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Study details
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A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients

University of Louisville
NCT IDNCT01638676ClinicalTrials.gov data as of Apr 2026
Phase

Phase 1/2

Target enrollment

55

Study length

about 15 years

Ages

18+

Locations

1 site in KY

About this study

This trial is testing the safety of Vemurafenib combined with Metformin in melanoma patients. The phase II part will also evaluate how well this combination works (clinical activity) for people with metastatic melanoma.

Based on ClinicalTrials.gov records.

What participants do

  • 1.Take Metformin
  • 2.Take Vemurafenib
PhasePhase 1/Phase 2
DrugMetformin
Routeoral
Primary goalObservation of CTCAE grade 4 or higher adverse events in six patients

Participation effort

Estimated from trial records. Details can vary by site.

Time + visits
Low13%
Logistics
Moderate50%

Logistics difficulty varies by site location and availability.

Trial highlights

Treatment details

Auto-extracted from trial records to preview treatments and outcomes.

Drug classes

metformin (Biguanide antidiabetic; reduces liver glucose production and improves insulin sensitivity), vemurafenib

Drug routes

oral

Endpoints

Primary: Observation of CTCAE grade 4 or higher adverse events in six patients

Secondary: Number of adverse events, Objective response rate (ORR)as measure of efficacy, Overall Survival Follow up, type of adverse events

Body systems

Oncology