Back to search results

Vemurafenib and Metformin for Melanoma

This study is testing the combination of two drugs, Vemurafenib and Metformin, for patients with advanced melanoma (Stage IIIC or IV) that has a specific genetic change called BRAFV600E. The main goal is to see how safe this combination is. Researchers also want to see if it helps shrink tumors or improve how long patients live. You could be eligible if you are at least 18 years old, have BRAFV600E melanoma, and meet other health criteria. The study is currently evaluating safety and clinical activity, but the recruitment status is unclear.

Study design
This is a Phase I/II study, meaning it first looks at safety (Phase I) and then at how well the treatment works (Phase II). It plans to include 55 participants.
What's involved
You would take Vemurafenib daily and Metformin twice daily in 28-day cycles. Treatment continues until your disease gets worse or side effects are too strong.
Compensation
Not stated in the trial record.
Follow-up
The primary safety observation period for Phase I is approximately six months. The record does not specify follow-up after treatment ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT01638676

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Louisville
~55 participants
Updated 2021-10-29 on ClinicalTrials.gov
What's tested:VemurafenibMetformin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Observation of CTCAE grade 4 or higher adverse events in six patients
Measured over Duration of phase I portion, approximately six months

Conditions

Melanoma

Explore related trials

MelanomaBRAF Gene

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

  • Jason A Chesney, MD PhD · PRINCIPAL_INVESTIGATOR · James Graham Brown Cancer Center-U of Louisville

Who to contact

Jason A Chesney, MD PhD
[email protected]
502-562-3429
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Absolute neutrophil count (ANC) ≥ 1.0 x 109/L;
Platelet count ≥ 50 x 109/L;
Hemoglobin ≥ 8 g/dL;
Serum creatinine ≤ 2 x upper limit of normal (ULN)
Total serum bilirubin ≤ 3 x ULN;
Serum aspartate transaminase (AST/SGOT) or serum alanine transaminase (ALT/SGPT) ≤ 3x ULN, and ≤ 4 x ULN if liver metastases are present. 7. Fertile males should use an effective method of contraception during treatment and for at least 3 months after completion of treatment, as directed by their physician; 8. Pre-menopausal females and females \< 2 years after the onset of menopause should have a negative pregnancy test at Screening. Pre-menopausal females must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 90 days after the last dose of study drug. Females of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for ≥ 1 year; 9. Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.

What this trial measures

  • Observation of CTCAE grade 4 or higher adverse events in six patientsDuration of phase I portion, approximately six months

    In the phase I portion, six patients will be enrolled and observed for CTCAE grade 4 or higher events. If three or more grade 4 or higher adverse events are observed among the six patients, the study will be halted.