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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 below
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I have been diagnosed with NF1 either through clinical criteria or a genetic test.
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I have a growing nerve tumor causing significant health issues.
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I have a tumor that can be measured by MRI and is at least 3 mL in volume.
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I am 18 years old or older.
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I had surgery for a growing nerve tumor that couldn't be fully removed and can be measured.
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I haven't had chemotherapy that lowers my blood cell counts in the last 3 weeks.
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My blood counts meet the required levels without recent transfusions.
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My kidney function is good based on tests.
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My liver is functioning well according to recent tests.
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My heart is strong, with good pumping ability and normal rhythm.
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I cannot or do not want to have surgery for my plexiform neurofibroma.

NF108-BINI Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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
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 • NCT02928224
78%
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%
Asthenia
16%
Oedema peripheral
16%
Stomatitis
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%
Rhinitis allergic
8%
Iron deficiency
8%
Infusion related reaction
8%
Hypertrichosis
8%
Nasopharyngitis
8%
Proteinuria
8%
Visual impairment
8%
Flank pain
8%
Rash
8%
Pruritus
8%
Pain in extremity
8%
Blood bilirubin increased
8%
Rhinnorrhoea
8%
Hypotension
5%
Musculoskeletal pain
5%
Pleural effusion
5%
Restless legs syndrome
5%
Chorioretinopathy
5%
Trichomegaly
5%
Rectal haemorrhage
5%
Hypocalcaemia
5%
Nail disorder
5%
Pruritus generalised
5%
Musculoskeletal chest pain
5%
Hypophosphataemia
5%
Nervous system disorder
5%
Colitis
5%
Abdominal pain lower
5%
Urinary incontinence
5%
Infection
5%
Wound
5%
Ascites
5%
Bone pain
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%
Large intestine perforation
3%
Confusional state
3%
Upper respiratory tract infection
3%
Streptococcal infection
3%
Large intestinal ulcer
3%
Cholangitis
3%
Large intestinal ulcer hemorrhage
3%
Kidney infection
3%
Back pain
3%
Alopecia
3%
Urinary tract infection bacterial
3%
Bacterial sepsis
3%
Tumour pain
3%
Hyperkeratosis
3%
Skin papilloma
3%
Melanocytic naevus
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
1,594 Previous Clinical Trials
2,282,429 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

Binimetinib (MEK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03231306 — Phase 2
Neurofibromatosis Research Study Groups: Open label study of Binimetinib (MEK162)
Neurofibromatosis Clinical Trial 2023: Binimetinib Highlights & Side Effects. Trial Name: NCT03231306 — Phase 2
Binimetinib (MEK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03231306 — Phase 2
~7 spots leftby Dec 2025
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