Study of Dabrafenib, Trametinib and Metformin for Melanoma Patients

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT02143050
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 30, 2014
Status verified
Nov 2023
Primary completion
Nov 17, 2017
Completion
Nov 17, 2017

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dabrafenib, Trametinib and Metformin
    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.

Primary Outcome Measure

Observation of two CTCAE drug related grade 4 toxicities in six patients. [ Time Frame: Duration of phase I portion, approxiately 6 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
James Graham Brown Cancer CenterLouisvilleKentucky40202-
James Graham Brown Cancer Center-Universityof LouisvilleLouisvilleKentucky40202-

Find similar trials in Louisville, KY

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
James Graham Brown Cancer Center· Louisville, KYJames Graham Brown Cancer Center-Universityof Louisville· Louisville, KY

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