Clinical Trial

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

Recruiting Phase 1/2
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Record status
This record was last updated October 29, 2021 (before its estimated June 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2012-07-11; most recent amendment 2021-10-22.
Trial Details
NCT Number NCT01638676
Lead Sponsor University of Louisville
Collaborators: James Graham Brown Cancer Center
Conditions Melanoma
Enrollment 55 participants
Start Date 2012-07
Primary Completion 2025-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2021-10-29