Phase 2 Melanoma Trial, Recruiting NCT01638676 Sponsor: University of Louisville Condition: Melanoma
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Phase 2 Melanoma Trial, Recruiting

NCT01638676
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must be 18 years of age or older
  • You must have been diagnosed with a specific type of melanoma (skin cancer) confirmed by a biopsy, with a gene mutation called BRAFV600E, and the cancer must be at an advanced stage (Stage IIIC or Stage IV)
  • You must be well enough to carry out basic daily activities, based on a standard health assessment scale (confirm with trial site)
  • Your doctor expects you to live for at least 3 months or longer
  • You must have at least one area of cancer that can be measured on a scan
  • Your blood, kidney, and liver test results must meet certain minimum levels, checked within 6 weeks before starting the trial (confirm with trial site)
  • If you are a man who could father a child, you must agree to use effective contraception during treatment and for at least 3 months after finishing treatment
  • If you are a woman who could become pregnant, you must have a negative pregnancy test before starting, and agree to use an approved form of birth control from that point until 90 days after the last dose
  • Women who cannot become pregnant (due to surgery or being post-menopausal for at least 1 year) may also be eligible
  • You must be willing and able to give written consent to participate before any study activities begin

Who may not be able to join:

  • You have previously been treated with a drug called Vemurafenib
  • You have a known allergy or sensitivity to Metformin or any of its ingredients
  • Your melanoma got worse while you were previously taking Metformin
  • You have had radiotherapy (radiation treatment) to areas other than the brain within the 2 weeks before starting the trial, or you are still experiencing side effects from previous radiation (except hair loss)
  • You are pregnant, breastfeeding, or unwilling to use the required methods of contraception
  • You have any other uncontrolled infection or health condition that could affect your participation in the trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
University of Louisville
Registry
ClinicalTrials.gov
Start date
1 July 2012
Est. completion
1 June 2025

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Observation of CTCAE grade 4 or higher adverse events in six patients

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov