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Kinase Inhibitor

Vemurafenib for Advanced Cancers with BRAF V600 Mutations

Q: What medical issues is Vemurafenib prescribed to address?

<p>Patients suffering from metastatic <a href="https://www.withpower.com/clinical-trials/melanoma">melanoma</a>, non-small cell lung carcinoma and irresectable melanomas can <a href="https://www.withpower.com/clinical-trials/all">all</a> benefit from the potential of Vemurafenib.</p>

Phase 2

Waitlist Available

Led By AeRang Kim

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must not have received prior exposure to a BRAF inhibitor (e.g. vemurafenib, dabrafenib or encorafenib)

Specified criteria for creatinine clearance or radioisotope glomerular filtration rate (GFR), bilirubin, serum glutamate pyruvate transaminase (SGPT), serum albumin, corrected QT (QTc) interval, and ability to swallow intact tablets must be met

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 4.5 years

Awards & highlights

Study Summary

This trial studies how well vemurafenib works in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with BRAF V600 mutations.

Who is the study for?

This trial is for kids and teens with advanced solid tumors, lymphoma, or histiocytic disorders that have a specific mutation (BRAF V600) and haven't responded to other treatments. They should be recovering from previous therapies, able to perform daily activities at least minimally despite any neurological issues, and not have been treated with BRAF inhibitors before.Check my eligibility

What is being tested?

The study tests how well vemurafenib works on patients with certain mutations in their cancer cells. It's designed to see if this drug can stop the growth of tumor cells by blocking enzymes they need to grow. The trial includes lab biomarker analysis as part of its procedures.See study design

What are the potential side effects?

Vemurafenib may cause side effects like rash, joint pain, fatigue, hair loss, heart problems (like changes in heartbeat), liver problems (like hepatitis), skin growths or cancers (like cutaneous squamous cell carcinoma), sensitivity to sunlight, and eye problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have never been treated with a BRAF inhibitor.

Select...

My kidney, liver functions, heart rhythm, and ability to swallow pills are within normal ranges.

Select...

My cancer has spread to the lining of my brain or spinal cord but can't be measured by standard methods.

Select...

My blood counts meet the required levels and I don't have cancer in my bone marrow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 4.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 4.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 4.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR)

Secondary outcome measures

Percentage of Patients Experiencing Grade 3 or Higher Adverse Events

Progress Free Survival (PFS)

Other outcome measures

Changes in Tumor Genomics

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%

Blood Alkaline Phosphatase Increased

10%

Dyspnoea

10%

Weight Decreased

10%

Anaemia

10%

Abdominal Pain

10%

Keratosis Pilaris

10%

Palmar-Plantar Erythrodysaesthesia Syndrome

10%

Rash Maculo-Papular

Blood Bilirubin Increased

Pain

Influenza Like Illness

Paraesthesia

Blood Creatinine Increased

Chest Pain

Peripheral Swelling

Dermal Cyst

Oropharyngeal Pain

Alanine Aminotransferase Increased

Folliculitis

Gamma-Glutamyltransferase Increased

Chills

Aspartate Aminotransferase Increased

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

Abdominal pain

Dehydration

Thrombocytopenia

Pleuritic pain

Pulmonary embolism

Seizure

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: Treatment (vemurafenib)Experimental Treatment2 Interventions

Patients receive vemurafenib PO BID on day 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vemurafenib

2015

Completed Phase 3

~3100

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,654 Previous Clinical Trials

40,933,149 Total Patients Enrolled

103 Trials studying Osteosarcoma

16,614 Patients Enrolled for Osteosarcoma

AeRang KimPrincipal InvestigatorChildren's Oncology Group

Frequently Asked Questions

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

What risks have been identified with the use of Vemurafenib?

"Vemurafenib's safety is considered to be quite reliable, as evidenced by the score of 2 given due to the existence of some clinical data indicating its security. However, there are currently no studies that evaluate efficacy."

Answered by AI

How many participants are being recruited for this experiment?

"As of September 22nd 2022, this clinical trial has ceased to recruit participants. It was first posted on July 24th 2017 and if you are looking for an alternative study involving central nervous system neoplasms or Vemurafenib there are currently 5642 and 45 studies respectively that remain open to recruitment."

Answered by AI

What further studies have been executed with Vemurafenib?

"Currently, 45 trials related to Vemurafenib are ongoing with 3 of them in Phase 3. While Toronto is a major hub for such research, there exist 1650 medical centres conducting studies on the compound across several regions."

Answered by AI

What medical issues is Vemurafenib prescribed to address?

"Patients suffering from metastatic melanoma, non-small cell lung carcinoma and irresectable melanomas can all benefit from the potential of Vemurafenib."

Answered by AI

Do I meet the criteria necessary to participate in this experiment?

"The requirements to join this medical trial are a diagnosis of central nervous system neoplasms, and being between one year old and 21 years old. At the moment there is space for up to four applicants."

Answered by AI

Are there any vacant opportunities for participants in this research?

"Unfortunately, this clinical trial is not open to new applicants presently. It was first published on July 24th 2017 and its most recent update was September 22nd 2022. But fear not! There are currently 5642 trials recruiting patients with central nervous system neoplasms as well 45 studies that involve Vemurafenib in the recruitment stage."

Answered by AI

Does this trial include participants aged 75 or older?

"For this medical trial, minors aged between 12 months and 21 years may be enrolled."

Answered by AI

How many health care locations are currently conducting this research?

"This medical trial is presently enrolling participants from across the United States. In addition to Orlando, Columbus and Buffalo, there are another 100 sites available for potential enrollees. It would be prudent to select a location closest to you in order to cut down on necessary travel arrangements if participation ensues."

Answered by AI