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

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
University of Louisville
Study ID
NCT01638676
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vemurafenib — DRUG
    Vemurafenib (960 mg PO daily) in patients with unresectable BRAFV600E positive Stage IIIC and Stage IV melanoma
  • Metformin — DRUG
    Metformin (500 mg PO BID x 2 weeks, then 850 mg PO BID)

Study Details

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.

Key Dates

Start date
Jul 31, 2012
Status verified
Oct 2021
Primary completion
Jun 30, 2025
Completion
Jun 30, 2027

Study Design

Enrollment
55 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Vemurafenib and Metformin

Primary Outcome Measure

Observation of CTCAE grade 4 or higher adverse events in six patients [ Time Frame: Duration of phase I portion, approximately six months ]

Locations (1)

FacilityCityStateZIPSite coordinators
James Graham Brown Cancer Center-University of LouisvilleLouisvilleKentucky40202
Jason A Chesney, MD PhD
[email protected]
502-562-3429
Sarah Lush, RN
[email protected]
502-540-1537

Find similar trials in Louisville, KY

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

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