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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
INTUITT-NF2 Trial 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.Check my eligibility
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.See study design
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.
INTUITT-NF2 Trial 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.
INTUITT-NF2 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Radiographic response rate (for each drug substudy)
Secondary outcome measures
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%
Toxicity To Various Agents
1%
Appendicitis
1%
Gastroenteritis
1%
Lower Respiratory Tract Infection
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%
Transaminases Abnormal
1%
Femoral Neck Fracture
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
INTUITT-NF2 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
2018
Completed Phase 3
~890
Find a Location
Who is running the clinical trial?
Scott R. Plotkin, MD, PhDLead Sponsor
TakedaIndustry Sponsor
1,203 Previous Clinical Trials
4,177,844 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people are eligible to participate in this research?
"Takeda, the sponsor of this clinical trial, needs a total of 80 eligible patients to proceed. The trial will be conducted at various hospitals including Mayo Clinic Hospital - Rochester in Rochester, Minnesota and New york University Langone Medical Center in New York, New York."
Answered by AI
In how many different medical clinics is this study being run today?
"There are several enrolling hospitals for this clinical trial, which include Mayo Clinic Hospital - Rochester in Rochester, Minnesota, New york University Langone Medical Center in New York, New York, and Johns Hopkins Hospital in Baltimore, Maryland."
Answered by AI
Does Brigatinib have any dangerous side effects?
"While there is some evidence that Brigatinib is safe for human consumption, its efficacy has not been proven. Therefore, it received a score of 2."
Answered by AI
Is this study currently recruiting new participants?
"The study, which was first advertised on clinicaltrials.gov on June 20th 2020, is still recruiting patients. The last time the posting was updated was October 18th 2022."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
California
What site did they apply to?
UCLA Medical Center
University of Miami
How many prior treatments have patients received?
0
Why did patients apply to this trial?
try to alleviate balance issues and ringing in my ears. I have had 2 surgeries and 2 rounds of radiation, and I am seeking trial for meningioma with metastasis.
PatientReceived 2+ prior treatments
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