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Kinase Inhibitor

Vemurafenib + Metformin for Melanoma

Phase 1 & 2
Recruiting
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
Male or female patients ≥ 18 years of age
Patients with histologically confirmed BRAFV600E melanoma (Stage IIIC or Stage IV, American Joint Commission on Cancer)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of study (approximately 60 months)
Awards & highlights
No Placebo-Only Group

Study Summary

This trial will test if a combination of the drugs Vemurafenib and Metformin is safe for melanoma patients, and if it is more effective than Vemurafenib alone.

Who is the study for?
This trial is for adults with BRAFV600E melanoma (Stage IIIC or IV) who can perform daily activities (ECOG PS 0-2) and have a life expectancy of at least 3 months. Participants must be able to use contraception, not be pregnant, and have adequate organ function. They cannot have had prior Vemurafenib treatment or known Metformin hypersensitivity.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of combining Vemurafenib with Metformin in treating melanoma. It aims to see if this combination improves response rates and survival with little toxicity based on earlier studies.See study design
What are the potential side effects?
Potential side effects may include typical reactions associated with Vemurafenib such as joint pain, rash, fatigue; and for Metformin they might experience digestive issues like nausea or diarrhea. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My melanoma is BRAFV600E positive and is at stage IIIC or IV.
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I can take care of myself and am up and about more than half of my waking hours.
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My blood, kidney, and liver tests meet the required levels.
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I am not pregnant and, if I can have children, I agree to use birth control during the study.
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I am a man who can father children and will use birth control during and for 3 months after treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of phase i portion, approximately six months
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of phase i portion, approximately six months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Observation of CTCAE grade 4 or higher adverse events in six patients
Secondary outcome measures
Number of adverse events
Objective response rate (ORR)as measure of efficacy
Overall Survival Follow up
+1 more

Side effects data

From 2015 Phase 3 trial • 675 Patients • NCT01006980
56%
Arthralgia
48%
Alopecia
47%
Fatigue
43%
Rash
40%
Photosensitivity Reaction
39%
Nausea
37%
Diarrhoea
34%
Headache
29%
Hyperkeratosis
29%
Skin Papilloma
26%
Pruritus
24%
Dry Skin
23%
Decreased Appetite
23%
Pain In Extremity
22%
Vomiting
21%
Pyrexia
20%
Squamous cell carcinoma of skin
18%
Erythema
17%
Sunburn
16%
Dysgeusia
16%
Back Pain
15%
Oedema Peripheral
15%
Constipation
15%
Myalgia
15%
Asthenia
15%
Cough
14%
Seborrhoeic Keratosis
13%
Actinic Keratosis
13%
Musculoskeletal Pain
12%
Melanocytic Naevus
12%
Dizziness
12%
Skin Lesion
11%
Abdominal Pain Upper
11%
Keratoacanthoma
11%
Nasopharyngitis
11%
Insomnia
10%
Dyspnoea
10%
Blood Alkaline Phosphatase Increased
10%
Weight Decreased
10%
Anaemia
10%
Abdominal Pain
10%
Keratosis Pilaris
10%
Palmar-Plantar Erythrodysaesthesia Syndrome
10%
Rash Maculo-Papular
9%
Influenza Like Illness
9%
Blood Bilirubin Increased
9%
Pain
9%
Paraesthesia
8%
Peripheral Swelling
8%
Dermal Cyst
8%
Blood Creatinine Increased
8%
Oropharyngeal Pain
8%
Chest Pain
8%
Alanine Aminotransferase Increased
8%
Folliculitis
7%
Aspartate Aminotransferase Increased
7%
Gamma-Glutamyltransferase Increased
7%
Chills
6%
Dyspepsia
6%
Conjunctivitis
6%
Upper Respiratory Tract Infection
6%
Depression
5%
Dermatitis Acneiform
5%
Abdominal Distension
5%
Influenza
5%
Hyperaesthesia
5%
Skin Exfoliation
5%
Flushing
4%
Acne
3%
Rash erythematous
3%
Basal cell carcinoma
3%
Urinary tract infection
2%
Malignant melanoma
2%
Lower respiratory tract infection
1%
Thrombocytopenia
1%
Dehydration
1%
Seizure
1%
Pleuritic pain
1%
Pulmonary embolism
1%
Uveitis
1%
Abdominal pain
1%
Pancreatitis
1%
Atrial fibrillation
1%
Myocardial infarction
1%
Chest pain
1%
Pneumonia
1%
Blood bilirubin increased
1%
Gamma-glutamyltransferase increased
1%
Acute kidney injury
1%
Pleural effusion
1%
Blood alkaline phosphatase increased
1%
Gastrointestinal haemorrhage
1%
Bowen's disease
1%
Loss of consciousness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vemurafenib
Vemurafenib After Crossover
Dacarbazine

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Vemurafenib and MetforminExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vemurafenib
2015
Completed Phase 3
~3130
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
334 Previous Clinical Trials
75,707 Total Patients Enrolled
9 Trials studying Melanoma
352 Patients Enrolled for Melanoma
James Graham Brown Cancer CenterOTHER
43 Previous Clinical Trials
9,186 Total Patients Enrolled
6 Trials studying Melanoma
321 Patients Enrolled for Melanoma
Jason A Chesney, MD PhDPrincipal InvestigatorJames Graham Brown Cancer Center-U of Louisville

Media Library

Melanoma Research Study Groups: Vemurafenib and Metformin
Melanoma Clinical Trial 2023: Vemurafenib Highlights & Side Effects. Trial Name: NCT01638676 — Phase 1 & 2
Vemurafenib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01638676 — Phase 1 & 2

Frequently Asked Questions

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

In what scenarios is Vemurafenib typically employed?

"Vemurafenib is employed to tackle metastatic melanoma, as well as conditions such as non-small cell lung carcinoma and unresectable melanomas. It has also been found to be effective for exercise."

Answered by AI

How many participants are involved in the research?

"Affirmative. Clinicaltrials.gov attests that recruitment for this medical study is still ongoing, having first been posted on July 1st 2012 and lastly edited on October 22nd 2021. The research is hoping to find 55 participants across a single site."

Answered by AI

Is this investigation still open to recruitment of participants?

"The clinical trial is actively recruiting, as reported on the website for clinicaltrials.gov. It was made available to prospective participants on July 1st 2012 and has been updated with new information most recently in October of 2021."

Answered by AI
~5 spots leftby Jun 2025