A Study on the Safety and Effectiveness of Vemurafenib and Metformin for Melanoma Patients

Sponsor: University of Louisville

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01638676

Provider View

This study aims to test the safety and effectiveness of combining Vemurafenib and Metformin in treating melanoma. It will assess how well this combination works and its safety for patients with advanced melanoma.

Patient Parameters

Program Overview

This study is designed to test how safe and effective the combination of two drugs, Vemurafenib and Metformin, is for treating melanoma, a type of skin cancer. The study is divided into two parts. The first part (Phase I) will focus on ensuring the combination is safe for patients. The second part (Phase II) will look at how well the combination works in treating the cancer. Researchers believe that using these two drugs together could improve treatment outcomes for patients with advanced melanoma, based on earlier studies and trials.

Description

This study is in two phases. In Phase I, researchers will check the safety of taking Vemurafenib (960 mg by mouth daily) with Metformin (500 mg by mouth twice a day for two weeks, then 850 mg twice a day) in patients with advanced melanoma that cannot be surgically removed. In Phase II, they will see how well this drug combination works. The safety of this treatment will be closely monitored throughout both phases. Patients will receive treatment in 28-day cycles, continuing until the cancer progresses or side effects become too severe.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older
  • Must have a confirmed diagnosis of BRAFV600E melanoma at Stage IIIC or IV
  • Must have a performance status score of 0 to 2, indicating ability to carry out daily activities
  • Must have a life expectancy of at least 3 months
  • Must have at least one measurable tumor
  • Must have adequate blood, kidney, and liver function based on recent lab tests
  • Men must use effective birth control during treatment and for 3 months after
  • Women who can become pregnant must have a negative pregnancy test and use birth control during and after treatment
  • Must provide written consent to participate

Exclusion Criteria

  • Cannot have been treated with Vemurafenib before
  • Cannot be allergic to Metformin or its ingredients
  • Cannot have had melanoma progress while on Metformin
  • Cannot have had recent radiation treatment unless fully recovered
  • Cannot be pregnant, breastfeeding, or unwilling to use birth control
  • Cannot have any uncontrolled infections or medical conditions that could affect the study

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