Vemurafenib for Melanoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
James Graham Brown Cancer Center-University of Louisville, Louisville, KYMelanomaVemurafenib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Duration of study (approximately 60 months)

Duration of phase I portion, approximately six months
Observation of CTCAE grade 4 or higher adverse events in six patients
Month 60
Objective response rate (ORR)as measure of efficacy
Month 60
Number of adverse events
type of adverse events
Week 12
Overall Survival Follow up

Trial Safety

Safety Progress

1 of 3

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1
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Side Effects for

Vemurafenib
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%Pain In Extremity
23%Decreased Appetite
22%Vomiting
21%Pyrexia
20%Squamous cell carcinoma of skin
18%Erythema
17%Sunburn
16%Back Pain
16%Dysgeusia
15%Myalgia
15%Constipation
15%Oedema Peripheral
15%Cough
15%Asthenia
14%Seborrhoeic Keratosis
13%Actinic Keratosis
13%Musculoskeletal Pain
12%Skin Lesion
12%Dizziness
12%Melanocytic Naevus
11%Abdominal Pain Upper
11%Insomnia
11%Nasopharyngitis
11%Keratoacanthoma
10%Anaemia
10%Abdominal Pain
10%Palmar-Plantar Erythrodysaesthesia Syndrome
10%Weight Decreased
10%Dyspnoea
10%Keratosis Pilaris
10%Blood Alkaline Phosphatase Increased
10%Rash Maculo-Papular
9%Blood Bilirubin Increased
9%Paraesthesia
9%Influenza Like Illness
9%Pain
8%Alanine Aminotransferase Increased
8%Oropharyngeal Pain
8%Chest Pain
8%Blood Creatinine Increased
8%Dermal Cyst
8%Peripheral Swelling
8%Folliculitis
7%Gamma-Glutamyltransferase Increased
7%Aspartate Aminotransferase Increased
7%Chills
6%Dyspepsia
6%Conjunctivitis
6%Upper Respiratory Tract Infection
6%Depression
5%Skin Exfoliation
5%Dermatitis Acneiform
5%Influenza
5%Hyperaesthesia
5%Flushing
5%Abdominal Distension
4%Acne
3%Urinary tract infection
3%Rash erythematous
3%Basal cell carcinoma
2%Malignant melanoma
2%Lower respiratory tract infection
1%Loss of consciousness
1%Thrombocytopenia
1%Pneumonia
1%Abdominal pain
1%Chest pain
1%Seizure
1%Atrial fibrillation
1%Bowen's disease
1%Blood alkaline phosphatase increased
1%Uveitis
1%Pancreatitis
1%Gamma-glutamyltransferase increased
1%Acute kidney injury
1%Pleuritic pain
1%Dehydration
1%Pleural effusion
1%Blood bilirubin increased
1%Pulmonary embolism
1%Gastrointestinal haemorrhage
1%Myocardial infarction
This histogram enumerates side effects from a completed 2015 Phase 3 trial (NCT01006980) in the Vemurafenib ARM group. Side effects include: Arthralgia with 56%, Alopecia with 48%, Fatigue with 47%, Rash with 43%, Photosensitivity Reaction with 40%.

Trial Design

1 Treatment Group

Vemurafenib and Metformin
1 of 1

Experimental Treatment

55 Total Participants · 1 Treatment Group

Primary Treatment: Vemurafenib · No Placebo Group · Phase 1 & 2

Vemurafenib and MetforminExperimental Group · 2 Interventions: Vemurafenib, Metformin · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vemurafenib
FDA approved
Metformin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: duration of study (approximately 60 months)

Who is running the clinical trial?

University of LouisvilleLead Sponsor
315 Previous Clinical Trials
73,126 Total Patients Enrolled
8 Trials studying Melanoma
361 Patients Enrolled for Melanoma
James Graham Brown Cancer CenterOTHER
43 Previous Clinical Trials
9,236 Total Patients Enrolled
6 Trials studying Melanoma
374 Patients Enrolled for Melanoma
Jason A Chesney, MD PhDPrincipal InvestigatorJames Graham Brown Cancer Center-U of Louisville

Eligibility Criteria

Age 18+ · All Participants · 15 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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