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

NCT01638676 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2021-10-29

No results posted yet for this study

Summary

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

Interventions

DRUG

Vemurafenib

Vemurafenib (960 mg PO daily) in patients with unresectable BRAFV600E positive Stage IIIC and Stage IV melanoma

DRUG

Metformin

Metformin (500 mg PO BID x 2 weeks, then 850 mg PO BID)

Sponsors & Collaborators

  • James Graham Brown Cancer Center

    collaborator OTHER

  • University of Louisville

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2025-06-30
Completion
2027-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01638676 on ClinicalTrials.gov