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CDK4/6 Inhibitor
Abemaciclib for Neurofibroma
Phase 1 & 2
Recruiting
Led By Andrea M Gross, M.D.
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
A neurofibroma or plexiform neurofibroma
Adequate performance scale (Lansky/Karnofsky >=70%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years of treatment or until disease progression or unacceptable treatment-related toxicity
Awards & highlights
Study Summary
This trial is testing a drug, abemaciclib, to see if it can help treat atypical neurofibromas, which are tumors that arise from nerves and can cause serious medical problems. The drug is taken orally, twice daily, in 28-day cycles.
Who is the study for?
This trial is for individuals aged 12 or older with Neurofibromatosis Type I (NF1) and at least one inoperable tumor measuring over 3 cm. Participants must not be pregnant, agree to use effective contraception, have no severe allergies to abemaciclib, and should not require certain other medications that could interfere with the study drug.Check my eligibility
What is being tested?
The trial is testing the safety and tolerability of a drug called abemaciclib for treating atypical neurofibromas associated with NF1. Patients will take this medication orally twice daily in cycles of 28 days for up to two years, possibly longer.See study design
What are the potential side effects?
Potential side effects of abemaciclib may include digestive issues like nausea and vomiting, possible infections due to lowered immune response, liver problems indicated by blood tests, fatigue, and reactions related to heart function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a neurofibroma or plexiform neurofibroma.
Select...
I can take care of myself but may not be able to do active work.
Select...
I have been diagnosed with NF1 based on symptoms or a genetic test.
Select...
I have a parent, sibling, or child with NF1.
Select...
I have been diagnosed with optic glioma.
Select...
I have freckles under my arms or in my groin area.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years of treatment or until disease progression or unacceptable treatment-related toxicity
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years of treatment or until disease progression or unacceptable treatment-related toxicity
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
safety of abemaciclib in patients with NF1 and a measurable ANF
Secondary outcome measures
Abemaciclib pharmacokinetics and pharmacodynamic
Effect of abemaciclib on ANF related pain and quality of life
Effect of abemaciclib on CDK4/6 target inhibition
+3 moreSide effects data
From 2018 Phase 2 trial • 132 Patients • NCT0210249091%
Diarrhoea
67%
Nausea
48%
Fatigue
45%
Decreased appetite
35%
Vomiting
27%
Anaemia
26%
Abdominal pain
23%
Asthenia
23%
Neutrophil count decreased
21%
Cough
20%
Constipation
20%
Headache
19%
Arthralgia
18%
White blood cell count decreased
18%
Neutropenia
15%
Alopecia
14%
Platelet count decreased
14%
Dry mouth
14%
Weight decreased
14%
Dysgeusia
13%
Dyspnoea
12%
Abdominal pain upper
12%
Back pain
12%
Dizziness
11%
Pyrexia
11%
Dyspepsia
11%
Oedema peripheral
11%
Blood creatinine increased
10%
Pain
9%
Stomatitis
9%
Aspartate aminotransferase increased
8%
Dry skin
8%
Thrombocytopenia
8%
Pruritus
8%
Lacrimation increased
8%
Dehydration
8%
Alanine aminotransferase increased
7%
Flatulence
7%
Urinary tract infection
7%
Upper respiratory tract infection
7%
Hypokalaemia
6%
Chills
6%
Musculoskeletal chest pain
6%
Musculoskeletal pain
6%
Anxiety
5%
Rash
5%
Gastrooesophageal reflux disease
5%
Myalgia
2%
Cellulitis
2%
Pleural effusion
1%
Atypical pneumonia
1%
Gastroenteritis viral
1%
Sepsis
1%
Hip fracture
1%
Pneumonitis
1%
Fall
1%
Lung infection
1%
Pneumothorax
1%
Febrile neutropenia
1%
Respiratory tract infection
1%
Haematotoxicity
1%
Sinus bradycardia
1%
Tachycardia
1%
Large intestinal obstruction
1%
Pancreatic enzyme abnormality
1%
Pancreatitis
1%
Varices oesophageal
1%
Electrocardiogram abnormal
1%
Liver function test abnormal
1%
Renal function test abnormal
1%
Bone pain
1%
Muscular weakness
1%
Acute kidney injury
1%
Pulmonary embolism
1%
Arterial thrombosis
1%
Epilepsy
100%
80%
60%
40%
20%
0%
Study treatment Arm
Abemaciclib
Trial Design
2Treatment groups
Experimental Treatment
Group I: 2/ Phase II Objective Response RateExperimental Treatment1 Intervention
Abemaciclib orally twice daily at the RP2D
Group II: 1/ Phase I Dose EscalationExperimental Treatment1 Intervention
Abemaciclib orally twice daily at escalating doses to determine the MTD/RP2D
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
2019
Completed Phase 2
~1710
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,665 Previous Clinical Trials
40,925,799 Total Patients Enrolled
3 Trials studying Neurofibromatosis
284 Patients Enrolled for Neurofibromatosis
Andrea M Gross, M.D.Principal InvestigatorNational Cancer Institute (NCI)
1 Previous Clinical Trials
52 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but may not be able to do active work.I have interstitial lung disease.I have a neurofibroma or plexiform neurofibroma.My blood, liver, kidney, and heart are functioning well.I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.I need medication that strongly affects liver enzymes.I have not received any treatment for my ANF before.I am 12 years old or older.I cannot swallow pills.I have been diagnosed with NF1 based on symptoms or a genetic test.You can't have an MRI or have a medical reason for not having an MRI according to the MRI guidelines.You must have at least one abnormal area in your body that measures at least 3 centimeters.Women who can have babies need to have a negative pregnancy test within 7 days before starting the medication abemaciclib.I do not have any unmanaged ongoing illnesses.I do not have a tumor related to NF1 that needs surgery or chemotherapy.I have severe nausea and vomiting that could interfere with taking medication.You have a severe allergy to abemaciclib or any of its ingredients.I am willing to not consume grapefruit or its juice during my treatment.I have a parent, sibling, or child with NF1.I do not have any active infections.I can understand and am willing to sign the consent form.I have been diagnosed with optic glioma.I have gone through puberty.I have freckles under my arms or in my groin area.
Research Study Groups:
This trial has the following groups:- Group 1: 1/ Phase I Dose Escalation
- Group 2: 2/ Phase II Objective Response Rate
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.
How many people can join this experiment at the most?
"Yes, if you consult clinicaltrials.gov, you'll see that this research is still recruiting individuals to participate. The trial was first posted on 29 November 2021 and the most recent update was 1 November 2022. So far, 50 people have been enrolled at a single site."
Answered by AI
What are the primary uses of abemaciclib in patient care?
"Abemaciclib is often used to treat patients with a high risk of cancer recurrence. Additionally, it has been shown to be effective against advanced hr+ her2- breast cancer, endocrine therapy, and other forms of breast cancer."
Answered by AI
Are participants currently being sought for this research?
"This clinical trial is currently recruiting patients, as reported on clinicaltrials.gov. The study was originally posted on 11/29/2021 and was most recently updated on 11/1/2022."
Answered by AI
Have their been other similar studies to this one before?
"Abemaciclib was first researched in 2009 by Eli Lilly and Company. One hundred and ninety-seven (97) live clinical trials are currently underway for Abemaciclib across 41 countries and 1276 cities."
Answered by AI
Who else is applying?
What site did they apply to?
National Institutes of Health Clinical Center
What portion of applicants met pre-screening criteria?
Met criteria
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