A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients
Phase 1/2
55
about 15 years
18+
1 site in KY
What this study is about
This trial is testing the safety of Vemurafenib combined with Metformin in melanoma patients. The phase II part will also evaluate how well this combination works (clinical activity) for people with metastatic melanoma.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Metformin
- 2.Take Vemurafenib
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
metformin (Biguanide antidiabetic; reduces liver glucose production and improves insulin sensitivity), vemurafenib
oral
Primary: Observation of CTCAE grade 4 or higher adverse events in six patients
Secondary: Number of adverse events, Objective response rate (ORR)as measure of efficacy, Overall Survival Follow up, type of adverse events
Oncology