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MEK Inhibitor
Binimetinib for Neurofibromatosis (NF108-BINI Trial)
Phase 2
Waitlist Available
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical diagnosis of NF1 using the NIH Consensus Conference criteria OR a documented constitutional NF1 mutation
Plexiform neurofibroma(s) that are progressive or causing significant morbidity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
NF108-BINI Trial Summary
This trial will evaluate if the MEK inhibitor, binimetinib, is an effective treatment for children and adults with neurofibromatosis type 1 and inoperable plexiform neurofibromas.
Who is the study for?
This trial is for children over 1 year old and adults with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas. Participants must have a measurable tumor, be able to swallow pills, have adequate organ function, and not have had recent chemotherapy or major surgery. Pregnant women, those on chronic steroids or immunosuppressants, with certain eye conditions or uncontrolled diseases are excluded.Check my eligibility
What is being tested?
The study tests binimetinib, a MEK inhibitor drug, on its ability to shrink tumors by at least 20% after up to 12 treatment cycles. It's an open-label phase II trial meaning everyone gets the drug and both researchers and participants know what's being given.See study design
What are the potential side effects?
Potential side effects of binimetinib may include vision changes due to retinal vein occlusion or increased intraocular pressure; heart issues like hypertension; gastrointestinal problems; liver enzyme elevations; muscle damage indicated by elevated CK levels; allergic reactions similar to other compounds.
NF108-BINI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with NF1 either through clinical criteria or a genetic test.
Select...
I have a growing nerve tumor causing significant health issues.
Select...
I have a tumor that can be measured by MRI and is at least 3 mL in volume.
Select...
I am 18 years old or older.
Select...
I had surgery for a growing nerve tumor that couldn't be fully removed and can be measured.
Select...
I haven't had chemotherapy that lowers my blood cell counts in the last 3 weeks.
Select...
My blood counts meet the required levels without recent transfusions.
Select...
My kidney function is good based on tests.
Select...
My liver is functioning well according to recent tests.
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My heart is strong, with good pumping ability and normal rhythm.
Select...
I cannot or do not want to have surgery for my plexiform neurofibroma.
NF108-BINI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline Target Tumor Volume at 12 months
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events
Side effects data
From 2022 Phase 3 trial • 702 Patients • NCT0292822478%
Diarrhoea
68%
Dermatitis acneiform
59%
Nausea
54%
Fatigue
51%
Vomiting
51%
Dry Skin
43%
Pyrexia
43%
Anaemia
41%
Decreased appetite
38%
Abdominal pain
38%
Constipation
35%
Dyspnoea
32%
Vision blurred
30%
Blood creatine increased
30%
Blood creatine phosphokinase increased
24%
Arthralgia
24%
Myalgia
24%
Skin fissures
22%
Back Pain
22%
Dizziness
19%
Malaise
19%
Urinary tract infection
19%
Headache
19%
Aspartate aminotransferase increased
16%
Stomatitis
16%
Asthenia
16%
Oedema peripheral
16%
PPE syndrome
16%
Hypomagnesaemia
16%
Rash maculo-papular
16%
Palmar-planar erythrodysaesthesia
16%
Chills
16%
Paronychia
16%
Rash pustular
16%
Alanine aminotransferase increased
16%
Dysgeusia
16%
Peripheral sensory neuropathy
14%
Cough
14%
Abdominal pain upper
14%
Infusion-related reaction
14%
Ejection fraction decreased
14%
Dry eye
11%
Trichiasis
11%
Vitreous floaters
11%
Pollakiuria
11%
Dyspepsia
11%
Hypoalbuminaemia
11%
Hypertension
11%
Tumour Pain
8%
Hypokalaemia
8%
Weight decreased
8%
Macular oedema
8%
Iron deficiency
8%
Rhinitis allergic
8%
Infusion related reaction
8%
Visual impairment
8%
Hypertrichosis
8%
Nasopharyngitis
8%
Proteinuria
8%
Flank pain
8%
Rash
8%
Pruritus
8%
Pain in extremity
8%
Blood bilirubin increased
8%
Rhinnorrhoea
8%
Hypotension
5%
Nail disorder
5%
Restless legs syndrome
5%
Pruritus generalised
5%
Chorioretinopathy
5%
Trichomegaly
5%
Rectal haemorrhage
5%
Pleural effusion
5%
Bone pain
5%
Nervous system disorder
5%
Hypocalcaemia
5%
Hypophosphataemia
5%
Colitis
5%
Abdominal pain lower
5%
Urinary incontinence
5%
Infection
5%
Wound
5%
Musculoskeletal chest pain
5%
Musculoskeletal pain
5%
Ascites
5%
Anal haemorrhage
5%
Insomnia
5%
Gastroesophageal reflux disease
5%
Abdominal distension
5%
Eczema
5%
Cystitis
5%
Renal failure
5%
Conjunctivitis
5%
Syncope
5%
Dehydration
5%
Dry Mouth
5%
Skin hyperpigmentation
5%
Muscle spasms
5%
Erythema
5%
Retinal detachment
5%
Pulmonary embolism
5%
Dysphonia
5%
Haematuria
5%
Blood creatinine increased
5%
Depression
5%
Palpitations
3%
Device occlusion
3%
Kidney infection
3%
Large intestine perforation
3%
Large intestinal ulcer
3%
Confusional state
3%
Upper respiratory tract infection
3%
Streptococcal infection
3%
Cholangitis
3%
Melanocytic naevus
3%
Large intestinal ulcer hemorrhage
3%
Alopecia
3%
Urinary tract infection bacterial
3%
Bacterial sepsis
3%
Tumour pain
3%
Hyperkeratosis
3%
Skin papilloma
3%
Back pain
3%
Rhabdomyolysis
3%
Rectal hemorrhage
3%
Urinary tract obstruction
3%
Epistaxis
3%
Colon cancer
3%
Sepsis
3%
Acute kidney injury
3%
Large intestine ulcer
3%
Neutropenia
3%
Bacteria sepsis
3%
Hydronephrosis
3%
Neuropathy peripheral
3%
Abdominal abscess
3%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combined Safety Lead-in
Phase 3: Triplet Arm
Phase 3: Doublet Arm
Phase 3: Control Arm
NF108-BINI Trial Design
1Treatment groups
Experimental Treatment
Group I: Open label study of Binimetinib (MEK162)Experimental Treatment1 Intervention
Subjects (≥ 18 years) (Stratum A) will receive a course of binimetinib by mouth twice a day (12 hours apart) of 45 mg/dose. Duration of each course is 4 weeks. After 8 courses, subjects will receive additional courses if MRI results showed at least 15% reduction in volume of the target tumor. Subjects can continue on therapy and will be evaluated at the end of 12 courses. Subjects who have ≥ 20% reduction in volume of the target tumor according to the MRI results can continue therapy up to an additional year (maximum of 24 total courses). Subjects who have not met the tumor reduction at the specified times will be removed from the study therapy. Subjects will be carefully monitored for toxicities associated with binimetinib.
Recruitment of subjects 1 - 17 years of age (Stratum B) is currently available. The pediatric maximum tolerated dose (MTD) of binimetinib the pediatric patients (Statum B) was established by a phase 1 study (NCT022).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Binimetinib
2018
Completed Phase 3
~1100
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,593 Previous Clinical Trials
2,282,594 Total Patients Enrolled
1 Trials studying Neurofibromatosis
45 Patients Enrolled for Neurofibromatosis
Array BioPharmaIndustry Sponsor
28 Previous Clinical Trials
1,357 Total Patients Enrolled
Pacific Pediatric Neuro-Oncology ConsortiumOTHER
14 Previous Clinical Trials
697 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can swallow pills.I have a muscle disorder that causes high CK levels, like muscular dystrophy.I have been diagnosed with NF1 either through clinical criteria or a genetic test.I have a growing nerve tumor causing significant health issues.I have a tumor that can be measured by MRI and is at least 3 mL in volume.I am 18 years old or older.I agree to use birth control or abstain from sex during and for 3 months after the study.I had surgery for a growing nerve tumor that couldn't be fully removed and can be measured.I have recovered from side effects of previous cancer treatments.It's been over a week since I last received treatment to help my blood cells recover.It's been over 4 weeks since my last biologic cancer treatment.I can take steroids for my hormone imbalances if needed.I haven't had radiation on my eye area and it's been over 6 months since my last radiation treatment on the tumor area.I have a low-grade brain tumor that needs treatment.I have a brain or nerve tumor and needed treatment in the last year.I do not have serious stomach or bowel problems.I have Gilbert's syndrome or am known to carry two copies of the UGT1A1*28 allele.It's been over 3 weeks since my major surgery and I've recovered.My blood counts meet the required levels without recent transfusions.My heart is strong, with good pumping ability and normal rhythm.I can do most activities by myself, even if I use a wheelchair.I have had radiation therapy to my eye area before.I do not have serious eye conditions like high eye pressure or uncontrolled glaucoma.My high blood pressure is severe and not controlled by medication.I plan to start a new intense workout routine after beginning the study treatment.I haven't had chemotherapy that lowers my blood cell counts in the last 3 weeks.My kidney function is good based on tests.My liver is functioning well according to recent tests.I am 18 years old or older.I am on long-term steroids or other drugs that weaken my immune system.I have previously been treated with a MEK inhibitor.I cannot or do not want to have surgery for my plexiform neurofibroma.I am not pregnant or breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: Open label study of Binimetinib (MEK162)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this an unprecedented clinical trial?
"Since 2011, Binimetinib has undergone extensive research and evaluation. The inception of this investigation was funded by Pfizer in 2011 with 183 participants. Following its Phase 2 drug approval, 59 live trials have been conducted across 1120 cities and 39 nations worldwide."
Answered by AI
Has Binimetinib been subjected to any prior research studies?
"Currently, 59 medical trials are underway researching Binimetinib. Three of these studies have advanced to Phase 3. In addition to the experiments being conducted in Melbourne, Victoria, 3073 sites around the world are contributing data for this medication's evaluation."
Answered by AI
How many individuals have been accepted into this research project?
"At this time, no new patients are being accepted for the clinical trial in question. It was first posted on November 28th 2017 and most recently updated December 4th 2021. If you're looking to join a medical study, there are currently 56 studies recruiting those with neurofibromatoses and 59 trials enrolling participants for Binimetinib treatment."
Answered by AI
At what locations can participants access this clinical trial?
"Across the United States of America, 22 different clinical trial sites are enrolling patients. Notably, there are locations in Los Angeles (University of California at Los Angeles), Cincinnati (Cinncinnati Children's Hospital Medical Center) and Washington D.C.(Children's National Medical Center)."
Answered by AI
For what medical issues is Binimetinib commonly prescribed?
"Binimetinib may be an effective therapy for those suffering from BRAF V600K mutation, metastatic melanoma, or unresectable melanoma."
Answered by AI
Has Binimetinib obtained the necessary clearance from the FDA?
"Given the nature of a Phase 2 trial, our department at Power assigned binimetinib a score of two as there is data that indicates its safety but none to confirm it's efficacy."
Answered by AI
Are there any opportunities for volunteers to join this research endeavor?
"This research study is no longer searching for participants. It was initially published on November 28th, 2017 and last revised on December 4th 2021. If you are seeking additional clinical trials, there are currently 56 different studies actively recruiting patients with neurofibromatoses and 59 experiments looking to enrol people in Binimetinib treatments."
Answered by AI
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