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B-Raf inhibitor and MEK inhibitor

Dabrafenib + Trametinib + Metformin for Melanoma

Phase 1 & 2
Waitlist Available
Led By Jason A Chesney, MD, PhD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights

Study Summary

This trial is testing a combination of two existing drugs, Dabrafenib and Trametinib, with the addition of Metformin to see if it is more effective than either drug alone, with the goal of improved clinical outcomes and survival for patients with metastatic melanoma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical Response Rate
Observation of two CTCAE drug related grade 4 toxicities in six patients.
Secondary outcome measures
To estimate the overall survival rates.
To explore the effect of other covariates on overall survival

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dabrafenib, Trametinib and MetforminExperimental Treatment3 Interventions
Dabrafenib 150 mg PO BID until progression or unacceptable toxicity. Trametinib 2 mg PO QD until progression or unacceptable toxicity. Metformin 500 mg PO BID x 2 weeks, then 850 mg PO BID until progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430
Dabrafenib
2011
Completed Phase 3
~4120
Trametinib
2014
Completed Phase 2
~1550

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,984 Total Patients Enrolled
9 Trials studying Melanoma
407 Patients Enrolled for Melanoma
James Graham Brown Cancer CenterOTHER
43 Previous Clinical Trials
9,218 Total Patients Enrolled
6 Trials studying Melanoma
376 Patients Enrolled for Melanoma
Jason A Chesney, MD, PhDPrincipal InvestigatorJames Graham Brown Cancer Center

Media Library

Dabrafenib and Trametinib (B-Raf inhibitor and MEK inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02143050 — Phase 1 & 2
Dabrafenib and Trametinib (B-Raf inhibitor and MEK inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02143050 — Phase 1 & 2
Melanoma Research Study Groups: Dabrafenib, Trametinib and Metformin
Melanoma Clinical Trial 2023: Dabrafenib and Trametinib Highlights & Side Effects. Trial Name: NCT02143050 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the enrollment criteria of this medical experiment encompass adults over 20 years old?

"According to the criteria for enrollment, this medical trial mandates that patients must be over 18 years old and no older than 100."

Answered by AI

How many individuals have been recruited to participate in this research project?

"Affirmative. The clinical trial, originally posted on September 1st 2014 and recently edited October 22nd 2021, is recruiting participants as indicated by the information shared on ClinicalTrials.gov. This project seeks 53 individuals from two medical centres to take part in it."

Answered by AI

What have been some of the prior explorations involving Metformin?

"Currently, there are 264 active clinical trials exploring the efficacy of Metformin with 49 studies in their final phase. While Boston is home to several Metformin-based investigations, a total of 7706 sites around the world have launched similar research projects."

Answered by AI

What conditions can Metformin be deployed to manage?

"Metformin is widely used to treat metastatic melanoma and other illnesses such as unresectable melanoma, physical activity deficiency, and type 1 diabetes mellitus."

Answered by AI

What are the eligibility requirements for taking part in this experiment?

"To qualify for this trial, applicants must have the diagnosis of melanoma and be between 18 to 100 years old. The study is hoping to enlist roughly 53 participants."

Answered by AI

Are there still vacancies for participants in this experiment?

"Affirmative, the information posted on clinicaltrials.gov attests that this research is presently enrolling volunteers. This investigation was initially published on September 1st 2014 and has since been updated as of October 22nd 2021. 53 participants are sought for between 2 sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Dabrafenib, Trametinib and Metformin for Melanoma Patients
Jason Chesney 2014. "Study of Dabrafenib, Trametinib and Metformin for Melanoma Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02143050.
~0 spots leftby Apr 2025
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