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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
Patients with histologically confirmed BRAFV600E melanoma (Stage IIIC or Stage IV, American Joint Commission on Cancer)
Adequate hematologic, renal, and liver function as defined by laboratory values performed within 42 days prior to initiation of dosing: Absolute neutrophil count (ANC) ≥ 1.0 x 109/L, Platelet count ≥ 50 x 109/L, Hemoglobin ≥ 8 g/dL, Serum creatinine ≤ 2 x upper limit of normal (ULN), Total serum bilirubin ≤ 3 x ULN, Serum aspartate transaminase (AST/SGOT) or serum alanine transaminase (ALT/SGPT) ≤ 3x ULN, and ≤ 4 x ULN if liver metastases are present
Must not have
Received radiotherapy for non CNS disease within the 2 weeks prior to commencing study treatment or have not recovered from side effects of all radiation-related toxicities to Grade ≤ 1, except for alopecia
Prior treatment with Vemurafenib
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration of study (approximately 60 months)
Awards & highlights
No Placebo-Only Group

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.
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.
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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My melanoma is BRAFV600E positive and is at stage IIIC or IV.
Select...
My blood, kidney, and liver tests meet the required levels.
Select...
I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had radiotherapy for non-brain issues in the last 2 weeks or I have recovered from its side effects.
Select...
I have been treated with Vemurafenib before.
Select...
My melanoma got worse while I was taking Metformin.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Observation of CTCAE grade 4 or higher adverse events in six patients
Secondary study objectives
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%
Constipation
15%
Oedema Peripheral
15%
Asthenia
15%
Myalgia
15%
Cough
14%
Seborrhoeic Keratosis
13%
Actinic Keratosis
13%
Musculoskeletal Pain
12%
Melanocytic Naevus
12%
Dizziness
12%
Skin Lesion
11%
Keratoacanthoma
11%
Abdominal Pain Upper
11%
Nasopharyngitis
11%
Insomnia
10%
Blood Alkaline Phosphatase Increased
10%
Anaemia
10%
Weight Decreased
10%
Dyspnoea
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%
Blood Creatinine Increased
8%
Dermal Cyst
8%
Chest Pain
8%
Peripheral Swelling
8%
Oropharyngeal Pain
8%
Alanine Aminotransferase Increased
8%
Folliculitis
7%
Chills
7%
Gamma-Glutamyltransferase Increased
7%
Aspartate Aminotransferase Increased
6%
Dyspepsia
6%
Conjunctivitis
6%
Upper Respiratory Tract Infection
6%
Depression
5%
Abdominal Distension
5%
Dermatitis Acneiform
5%
Influenza
5%
Hyperaesthesia
5%
Skin Exfoliation
5%
Flushing
4%
Acne
3%
Rash erythematous
3%
Basal cell carcinoma
3%
Urinary tract infection
2%
Lower respiratory tract infection
2%
Malignant melanoma
1%
Seizure
1%
Abdominal pain
1%
Pulmonary embolism
1%
Thrombocytopenia
1%
Dehydration
1%
Pleuritic pain
1%
Uveitis
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
~3550
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
347 Previous Clinical Trials
77,546 Total Patients Enrolled
9 Trials studying Melanoma
348 Patients Enrolled for Melanoma
James Graham Brown Cancer CenterOTHER
43 Previous Clinical Trials
9,141 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
~2 spots leftby Jun 2025
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