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Kinase Inhibitor

Vemurafenib + Metformin for Melanoma

Q: In what scenarios is Vemurafenib typically employed?

<p>Vemurafenib is employed to tackle metastatic <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, as well as conditions such as non-small cell lung carcinoma and unresectable melanomas. It has also been found to be effective for exercise.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of study (approximately 60 months)

Awards & highlights

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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My melanoma is BRAFV600E positive and is at stage IIIC or IV.

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My blood, kidney, and liver tests meet the required levels.

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of phase i portion, approximately six months

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%

Asthenia

15%

Oedema Peripheral

15%

Constipation

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%

Dyspnoea

10%

Weight Decreased

10%

Blood Alkaline Phosphatase Increased

10%

Anaemia

10%

Abdominal Pain

10%

Keratosis Pilaris

10%

Palmar-Plantar Erythrodysaesthesia Syndrome

10%

Rash Maculo-Papular

Blood Bilirubin Increased

Influenza Like Illness

Pain

Paraesthesia

Chest Pain

Peripheral Swelling

Dermal Cyst

Blood Creatinine Increased

Oropharyngeal Pain

Alanine Aminotransferase Increased

Folliculitis

Aspartate Aminotransferase Increased

Gamma-Glutamyltransferase Increased

Chills

Dyspepsia

Conjunctivitis

Upper Respiratory Tract Infection

Depression

Dermatitis Acneiform

Abdominal Distension

Influenza

Hyperaesthesia

Skin Exfoliation

Flushing

Acne

Rash erythematous

Basal cell carcinoma

Urinary tract infection

Malignant melanoma

Lower respiratory tract infection

Dehydration

Pulmonary embolism

Pleuritic pain

Seizure

Abdominal pain

Thrombocytopenia

Uveitis

Pancreatitis

Atrial fibrillation

Myocardial infarction

Chest pain

Pneumonia

Blood bilirubin increased

Gamma-glutamyltransferase increased

Acute kidney injury

Pleural effusion

Blood alkaline phosphatase increased

Gastrointestinal haemorrhage

Bowen's disease

Loss of consciousness

100%

80%

60%

40%

20%

Study treatment Arm

Vemurafenib

Vemurafenib After Crossover

Dacarbazine

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

~3100

Metformin

2006

Completed Phase 4

~2430

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor

338 Previous Clinical Trials

75,929 Total Patients Enrolled

9 Trials studying Melanoma

352 Patients Enrolled for Melanoma

James Graham Brown Cancer CenterOTHER

43 Previous Clinical Trials

9,163 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

Recent research and studies

Pigment Cell & Melanoma ResearchJournal

Is It Time to Test Biguanide Metformin in the Treatment of Melanoma?

Cerezo, Michael, Tijana Tomic, Robert Ballotti, and Stéphane Rocchi. 2014. “Is It Time to Test Biguanide Metformin in the Treatment of Melanoma?”. Pigment Cell & Melanoma Research. Wiley. doi:10.1111/pcmr.12267.

clinicaltrials.govStudy

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

Jason Chesney 2012. "A Phase I/II Trial of Vemurafenib and Metformin to Melanoma Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01638676.

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