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

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.

Trial Details

NCT ID
NCT01638676
Phase
PHASE1 / PHASE2
Sponsor
University of Louisville
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Vemurafenib
  • Metformin
Locations (sample)
  • Louisville, Kentucky, United States

Key Eligibility Criteria

  • Male or female patients ≥ 18 years of age;
  • Patients with histological confirmed BRAFV600E melanoma (Stage IIIC or Stage IV, American Joint Commission on Cancer);
  • Eastern Cooperative Oncology Group (ECOG) Performance Status(PS) of 0 to 2;
  • Life expectancy ≥ 3 months;

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

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