Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT01638676

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

Led by University of Louisville · Updated on 2021-10-29

55

Participants Needed

1

Research Sites

778 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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female patients 18 years of age or older
  • Histologically confirmed BRAFV600E melanoma at Stage IIIC or Stage IV
  • ECOG Performance Status of 0 to 2
  • Life expectancy of at least 3 months
  • At least one measurable tumor site by RECIST 1.1
  • Adequate blood counts, kidney, and liver function within 42 days before treatment:
    • Absolute neutrophil count at least 1.0 x 10^9/L
    • Platelet count at least 50 x 10^9/L
    • Hemoglobin at least 8 g/dL
    • Serum creatinine no more than twice the upper limit of normal
    • Total bilirubin no more than three times the upper limit of normal
    • AST/ALT no more than three times the upper limit of normal, or four times if liver metastases present
  • Fertile males must use effective contraception during treatment and for 3 months after
  • Pre-menopausal females or females less than 2 years post-menopause must have a negative pregnancy test and use birth control from screening until 90 days after last dose
  • Females of non-childbearing potential must be surgically sterile or postmenopausal for at least 1 year
  • Written informed consent obtained before any study procedures
Not Eligible

You will not qualify if you...

  • Prior treatment with Vemurafenib
  • Known allergy or hypersensitivity to Metformin or its components
  • Previous melanoma progression while on Metformin
  • Radiotherapy for non-CNS disease within 2 weeks before starting study treatment or unresolved radiation side effects above Grade 1 except alopecia
  • Pregnant or breastfeeding women or those refusing to use contraception
  • Any uncontrolled infection or medical condition that would interfere with the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

James Graham Brown Cancer Center-University of Louisville

Louisville, Kentucky, United States, 40202

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here