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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: James Graham Brown Cancer Center to University of Louisville
    • Primary completion date: Jun 2018 to Jun 2025
    • Study completion date: Jun 2019 to Jun 2027
    • Collaborator revised
    v9
  2. 2 versions Re-verified since Feb 29, 2016, no change to tracked fieldsv7-v8
  3. Site contact updatedv6
  4. 2 versions Re-verified since Nov 13, 2013, no change to tracked fieldsv4-v5
  5. Lead sponsor: Jason A Chesney, MD, PhD to James Graham Brown Cancer Center
    • Collaborators expanded, about 3 words
    v3
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Number NCT01638676
Lead Sponsor University of Louisville
Collaborators: James Graham Brown Cancer Center
Conditions
(from sponsor)		 Melanoma
Related terms Melanoma
Enrollment 55 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov