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Tyrosine Kinase Inhibitor
Targeted Therapy for Neurofibromatosis (INTUITT-NF2 Trial)
Phase 2
Recruiting
Led By Scott Plotkin, MD
Research Sponsored by Scott R. Plotkin, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female patients must meet specific contraceptive requirements
Male patients must meet specific contraceptive requirements
Must not have
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Concurrent use of enzyme-inducing antiepileptic drugs (EIAEDs)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug, brigatinib, to see if it is effective in treating patients with NF2 who have progressive tumors of VS, non-VS, meningiomas, and ependymomas.
Who is the study for?
This trial is for individuals with neurofibromatosis type 2 (NF2) and related progressive tumors like vestibular schwannomas, meningiomas, or ependymomas. Participants must be at least 12 years old, weigh over 40 kg, have a pathogenic NF2 gene variant or meet specific diagnostic criteria, and have measurable disease progression within the last three years. They should not need tumor treatment within six months of joining and must agree to use contraception.
What is being tested?
The INTUITT-NF2 study is testing Neratinib and Brigatinib in separate substudies to see their effects on different types of tumors associated with NF2. It's a phase II trial where patients are given one of these drugs to measure their impact on tumor growth.
What are the potential side effects?
Potential side effects may include digestive issues such as diarrhea, liver problems like elevated enzymes, heart issues including high blood pressure or abnormal heartbeat, lung complications such as shortness of breath or coughing, muscle pain or weakness, skin rash or itching.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am following the required birth control measures.
Select...
I am following the required contraceptive measures.
Select...
I am mostly able to care for myself and carry out daily activities.
Select...
I have a confirmed NF2 diagnosis or a pathogenic NF2 gene variant.
Select...
I have a family history of NF2 and specific related health conditions.
Select...
My NF2-related tumor cannot be removed with surgery.
Select...
I am 12 years or older and weigh at least 40 kg.
Select...
I have a confirmed NF2 gene mutation or meet the NIH/Manchester criteria for NF2.
Select...
My cancer can be measured by MRI.
Select...
I am 12 years old or older.
Select...
I have a tumor related to NF2 that cannot be surgically removed.
Select...
I have NF2, shown by tumors on my hearing nerves or a family history plus specific symptoms.
Select...
I am 12 years or older and weigh at least 40 kg.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any serious illnesses or social situations that would stop me from following the study's requirements.
Select...
I am currently taking medication for epilepsy.
Select...
I have serious heart problems that are not under control.
Select...
I have a condition that affects how my body absorbs medication taken by mouth.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Radiographic response rate (for each drug substudy)
Secondary study objectives
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability
Side effects data
From 2021 Phase 3 trial • 275 Patients • NCT0273750157%
Diarrhoea
50%
Blood Creatine Phosphokinase Increased
36%
Cough
32%
Hypertension
32%
Nausea
26%
Back Pain
26%
Aspartate Aminotransferase Increased
23%
Headache
23%
Dyspnoea
23%
Alanine Aminotransferase Increased
23%
Lipase Increased
22%
Vomiting
21%
Fatigue
21%
Pruritus
20%
Arthralgia
19%
Constipation
18%
Rash
17%
Dizziness
15%
Muscle Spasms
15%
Pyrexia
13%
Upper Respiratory Tract Infection
13%
Abdominal Pain
13%
Blood Alkaline Phosphatase Increased
13%
Asthenia
12%
Decreased Appetite
11%
Dyspepsia
11%
Musculoskeletal Pain
10%
Insomnia
10%
Dermatitis Acneiform
10%
Myalgia
10%
Oedema Peripheral
10%
Blood Cholesterol Increased
10%
Oropharyngeal Pain
9%
Productive Cough
9%
Nasopharyngitis
9%
Anaemia
9%
Paraesthesia
9%
Stomatitis
9%
Musculoskeletal Chest Pain
8%
Non-Cardiac Chest Pain
8%
Abdominal Pain Upper
7%
Urinary Tract Infection
7%
Bradycardia
7%
Epistaxis
7%
Pneumonia
7%
Pain In Extremity
7%
Rash Erythematous
6%
Dry Skin
6%
Rash Maculo-Papular
6%
Dysphonia
6%
Electrocardiogram Qt Prolonged
6%
Dry Mouth
6%
Eczema
6%
Blood Creatinine Increased
5%
Sinus Bradycardia
5%
Respiratory Tract Infection
5%
Hyperglycaemia
5%
Hypokalaemia
5%
Hypercholesterolaemia
5%
Vision Blurred
5%
Blood Lactate Dehydrogenase Increased
5%
Hypophosphataemia
5%
Rhinorrhoea
5%
Malaise
4%
Depression
4%
Dysgeusia
4%
Influenza Like Illness
4%
Peripheral Swelling
4%
Gamma-Glutamyltransferase Increased
4%
Neoplasm Progression
2%
Neutrophil Count Decreased
2%
Pulmonary Embolism
2%
Pleural Effusion
2%
Interstitial Lung Disease
2%
Hypocalcaemia
2%
Hypoaesthesia
2%
Taste Disorder
2%
Hypotension
1%
Transaminases Abnormal
1%
Femoral Neck Fracture
1%
Toxicity To Various Agents
1%
Lower Respiratory Tract Infection
1%
Appendicitis
1%
Gastroenteritis
1%
Visual Impairment
1%
Disseminated Intravascular Coagulation
1%
Confusional State
1%
Cerebrovascular Accident
1%
Dysarthria
1%
Encephalopathy
1%
Peripheral Sensory Neuropathy
1%
Cholestasis
1%
Muscular Weakness
1%
Malignant Pleural Effusion
1%
Cancer Pain
1%
Diffuse Large B-Cell Lymphoma
1%
Invasive Breast Carcinoma
1%
Lung Neoplasm Malignant
1%
Ovarian Cancer Stage I
1%
Neutropenia
1%
Gout
1%
Syncope
1%
Seizure
1%
Memory Impairment
1%
Vocal Cord Paralysis
1%
Pericardial Effusion
1%
Cardiac Tamponade
1%
Acute Myocardial Infarction
1%
Angina Pectoris
1%
Arrhythmia
1%
Pneumonitis
1%
Pneumonia Aspiration
1%
Pneumothorax
1%
Pulmonary Oedema
1%
Dysphagia
1%
Inguinal Hernia
1%
Neutropenic Colitis
1%
Oesophageal Obstruction
1%
Cholecystitis
1%
Bile Duct Stone
1%
Multiple Organ Dysfunction Syndrome
1%
Sudden Death
1%
C-Reactive Protein Increased
1%
Fall
1%
Ligament Rupture
1%
Hypoalbuminaemia
1%
Viral Infection
1%
Metastases To Meninges
1%
Lung Adenocarcinoma
1%
Squamous Cell Carcinoma Of Skin
1%
Hypoglycaemia
1%
Delirium
1%
Balance Disorder
1%
Partial Seizures
1%
Atrial Fibrillation
1%
Hepatocellular Injury
1%
Acute Kidney Injury
1%
Photopsia
1%
Metastases To Central Nervous System
1%
Hyperkalaemia
1%
Cognitive Disorder
1%
Gastric Haemorrhage
1%
Mucosal Inflammation
1%
Gastrooesophageal Reflux Disease
1%
Respiratory Distress
100%
80%
60%
40%
20%
0%
Study treatment Arm
Randomized Phase: Brigatinib 90 mg QD/180 QD
Randomized Phase: Crizotinib 250 mg BID
Crossover Phase: Brigatinib 90 mg QD/180 mg QD
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Sub-study B (neratinib)Experimental Treatment1 Intervention
The first three participants treated in this arm will receive neratinib 200 mg mg by mouth daily. If these participants tolerate the medication well, subsequent participants will receive neratinib 240 mg by mouth daily.
Group II: Sub-study A (brigatinib) - CLOSED TO ENROLLMENTExperimental Treatment1 Intervention
Subjects treated in this arm will receive brigatinib 90 mg by mouth daily for 7 days and then increased to 180 mg by mouth daily if the drug is tolerated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Neratinib
2014
Completed Phase 2
~1970
Brigatinib
2019
Completed Phase 3
~1240
Find a Location
Who is running the clinical trial?
Scott R. Plotkin, MD, PhDLead Sponsor
TakedaIndustry Sponsor
1,233 Previous Clinical Trials
4,148,126 Total Patients Enrolled
The Children's Tumor FoundationOTHER
7 Previous Clinical Trials
20,202 Total Patients Enrolled
1 Trials studying Neurofibromatosis
65 Patients Enrolled for Neurofibromatosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery in the last 30 days.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I am following the required birth control measures.I have been cancer-free from a different cancer for 2 years and am at low risk of it coming back.I am following the required contraceptive measures.I don't have any serious illnesses that could stop me from completing the treatment.I am mostly able to care for myself and carry out daily activities.I have a confirmed NF2 diagnosis or a pathogenic NF2 gene variant.I have a family history of NF2 and specific related health conditions.My NF2-related tumor cannot be removed with surgery.I am 12 years or older and weigh at least 40 kg.I have a confirmed NF2 gene mutation or meet the NIH/Manchester criteria for NF2.My NF2-related tumor has grown in the last 3 years.My cancer can be measured by MRI.Your recent lab test results need to meet certain standards before starting the study drug.My brain or spinal tumor may need treatment soon.I haven't taken specific drugs that affect liver enzymes in the last 2 weeks.I am 12 years old or older.I am not pregnant or less than a year into menopause.Your recent lab test results need to be within a certain range before you can start taking the study drug.I have a tumor related to NF2 that cannot be surgically removed.I am currently taking medication for epilepsy.You have had serious allergic reactions to drugs similar to neratinib.My target tumor has not been radiated in the last 3 years.You must have specific areas of disease that can be measured.I have serious heart problems that are not under control.I have NF2, shown by tumors on my hearing nerves or a family history plus specific symptoms.I am 12 years or older and weigh at least 40 kg.I have a condition that affects how my body absorbs medication taken by mouth.You are expected to live for more than 1 year.I haven't had chemotherapy in the last 4 weeks or have waited for 5 half-lives of the drug.
Research Study Groups:
This trial has the following groups:- Group 1: Sub-study B (neratinib)
- Group 2: Sub-study A (brigatinib) - CLOSED TO ENROLLMENT
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.
Neurofibromatosis Patient Testimony for trial: Trial Name: NCT04374305 — Phase 2
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