RecruitingPhase 1Phase 2NCT01638676

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

A Phase I/II Trial of Vemurafenib and Metformin to Unresectable Stage IIIC and Stage IV BRAF.V600E+ Melanoma Patients

Sponsor

University of Louisville

Enrollment

55 participants

Start Date

Jul 1, 2012

Study Type

INTERVENTIONAL

Conditions

Melanoma

Summary

The main purpose of this study is to evaluate the safety of Vemurafenib in combination with Metformin in melanoma patients. The phase II part of the study will also evaluate the clinical activity of the combined regiment. Based on pre-clinical studies and a phase I trial, the investigators hypothesize that the combination of an FDA-approved non-toxic dose of oral Metformin with Vemurafenib will yield little toxicity and improve clinical outcomes in terms of objective response rates and survival in metastatic melanoma patients.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the combination of two drugs — vemurafenib (a targeted cancer therapy) and metformin (a diabetes medication that may also slow cancer growth) — in patients with advanced melanoma that carries a specific genetic mutation called BRAF V600E. **You may be eligible if...** - You are 18 or older - You have been diagnosed with advanced melanoma (Stage IIIC or Stage IV) that has tested positive for the BRAF V600E mutation - Your cancer is measurable on imaging scans - You are reasonably functional in daily activities - Your blood counts, kidney function, and liver function are within acceptable ranges - Your life expectancy is at least 3 months **You may NOT be eligible if...** - Your melanoma does not have the BRAF V600E mutation - You have had prior treatment with vemurafenib or a similar BRAF-targeting drug - Your cancer cannot be measured on scans - You have serious heart, liver, or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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