Is it time to test biguanide metformin in the treatment of melanoma?
Michael Cerezo, Tijana Tomic, Robert Ballotti...
https://pubmed.ncbi.nlm.nih.gov/24862830Actively Recruiting
Phase 1
Phase 2
Age: 18Years +
All Genders
ID01638676
A Phase I/II Trial of Vemurafenib and Metformin for Unresectable Stage IIIC and Stage IV BRAF V600E+ Melanoma Patients
Led by University of Louisville · Updated on 2021-10-29
55
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University of Louisville
Lead Sponsor
J
James Graham Brown Cancer Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and clinical activity of a combination treatment using Vemurafenib and Metformin for patients with unresectable Stage IIIC and Stage IV melanoma that is positive for the BRAF V600E mutation. This Phase I/II study aims to determine if the combined regimen has acceptable toxicity and improves objective response rates and survival outcomes in metastatic melanoma patients, based on earlier pre-clinical studies and a Phase I trial. The study involves two phases: Phase I focuses on assessing the safety of Vemurafenib given orally at 960 mg daily combined with Metformin starting at 500 mg twice daily for two weeks, then increasing to 850 mg twice daily. Phase II will evaluate the clinical effectiveness of this combination. Treatment is given in 28-day cycles and continues until the disease progresses or unacceptable side effects occur. The safety profile is monitored throughout both phases. Participants will undergo evaluations including safety monitoring for severe side effects, tumor response assessments, and overall survival follow-up every 12 weeks for up to three years after the last dose. Laboratory tests, imaging to measure tumor size, and other assessments will be performed regularly during the study period, which is estimated to last about 60 months. The main outcome measured is the occurrence of severe adverse events, along with treatment effectiveness and overall survival.
CONDITIONS
Brief Title
A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female patients 18 years of age or older
- Histologically confirmed BRAF V600E positive melanoma at Stage IIIC or Stage IV
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 3 months
- At least one measurable tumor site by RECIST 1.1 criteria
- Adequate blood counts, kidney, and liver function within 42 days before starting treatment
- Fertile males agree to use effective contraception during treatment and for 3 months afterward
- Premenopausal females or females less than 2 years post-menopause must have a negative pregnancy test and agree to use contraception during and 90 days after treatment
- Females not of childbearing potential may participate if surgically sterile or postmenopausal for at least 1 year
- Written informed consent obtained before any study procedures
You will not qualify if you...
- Previous treatment with Vemurafenib
- Known allergy to Metformin or its components
- Melanoma progression while on Metformin
- Radiotherapy for non-brain disease within 2 weeks before starting study treatment or unresolved radiation side effects above Grade 1 except hair loss
- Pregnant, breastfeeding, or refusing to use effective pregnancy prevention methods
- Any uncontrolled infection or medical condition that could interfere with study conduct
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive oral Vemurafenib daily combined with Metformin twice daily, starting at 500 mg for 2 weeks and then 850 mg twice daily. Treatment cycles last 28 days and continue until disease progression or unacceptable toxicity occurs.
Regular visits as per protocol for safety and efficacy monitoring
Follow-up
Duration - Up to 3 years after last drug dose
Participants are monitored for overall survival and adverse events after completing treatment. Follow-up occurs every 12 weeks for up to 3 years after the last drug dose.
Visits every 12 weeks (+/- 7 days) after treatment ends
Trial Site Locations
Total: 1 location
1
James Graham Brown Cancer Center-University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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