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Kinase Inhibitor
Vemurafenib for Advanced Cancers with BRAF V600 Mutations
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
Must not have
Patients receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant
Patients who are currently receiving drugs that are inhibitors or inducers of p-glycoprotein (P-gp) or adenosine triphosphate (ATP)-binding cassette, subfamily G, member 2 (ABCG2 [BCRP])
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 4.5 years
Awards & highlights
No Placebo-Only Group
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am taking medication to prevent graft-versus-host disease after a bone marrow transplant.
Select...
I am not taking medication that affects p-glycoprotein or ABCG2.
Select...
I am not taking drugs that strongly affect liver enzyme CYP3A4.
Select...
I have an active type of skin cancer known as squamous cell carcinoma.
Select...
My brain tumor is classified as low grade (WHO grades I or II).
Select...
I do not have any infections that are currently uncontrolled.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective Response Rate (ORR)
Secondary study objectives
Percentage of Patients Experiencing Grade 3 or Higher Adverse Events
Progress Free Survival (PFS)
Other study objectives
Changes in Tumor Genomics
Side effects data
From 2015 Phase 3 trial • 675 Patients • NCT0100698056%
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%
Dyspnoea
10%
Anaemia
10%
Weight Decreased
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%
Oropharyngeal Pain
8%
Dermal Cyst
8%
Chest Pain
8%
Peripheral Swelling
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%
Malignant melanoma
2%
Lower respiratory tract infection
1%
Abdominal pain
1%
Seizure
1%
Pleuritic pain
1%
Thrombocytopenia
1%
Dehydration
1%
Pulmonary embolism
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: 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
~3560
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,938 Previous Clinical Trials
41,023,184 Total Patients Enrolled
36 Trials studying Rhabdoid Tumor
14,930 Patients Enrolled for Rhabdoid Tumor
AeRang KimPrincipal InvestigatorChildren's Oncology Group