Study of Dabrafenib, Trametinib and Metformin for Melanoma Patients

ClinicalTrials.gov ID: NCT02143050

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Official title

A Phase I/II Trial of Dabrafenib, Trametinib and Metformin Administered to Unresectable Stage IIIC and Stage IV BRAF V600E + Melanoma Patients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The main purpose is to evaluate the clinical response, safety and survival of the FDA approved drugs Dabrafenib, Trametinib in combination with Metformin. Investigators hypothesize that the combination of an FDA approved non toxic dose of oral Metformin with the B-Raf inhibitor, Dabrafenib and the MEK inhibitor, Trametinib will yield little toxicity and improve clinical outcomes in terms of objective response rates and survival in metastatic melanoma patients.

Study identification

NCT ID: NCT02143050
Recruitment status: Withdrawn
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: University of Louisville; Other
Enrollment: Not listed

Conditions and interventions

Conditions

Melanoma

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 100 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 2014 (Type not available)
Primary completion: Nov 17, 2017 (Actual)
Completion: Nov 17, 2017 (Actual)
Last update posted: Nov 18, 2023

2014 – 2017

United States locations

U.S. sites: 2
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
James Graham Brown Cancer Center-Universityof Louisville	Louisville	Kentucky	40202	—
James Graham Brown Cancer Center	Louisville	Kentucky	40202	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT02143050, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 18, 2023 · Synced Nov 15, 2026