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Cyclin-Dependent Kinase (CDK) Inhibitor
Abemaciclib for Meningioma
Phase 2
Waitlist Available
Led By Nader Sanai, MD
Research Sponsored by Nader Sanai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Resected tissue must demonstrate: (a) RB positivity on immunohistochemistry (IHC); or, no RB mutations on next-generation sequencing (NGS).
Ability to swallow oral medications.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is to study if the drug abemaciclib can be used to treat brain tumors by comparing it to a placebo. It is a randomized, double-blinded study, where neither the participants nor researchers know which treatment is being given.
Who is the study for?
Adults over 18 with newly-diagnosed grade 3 meningioma, who've completed radiation therapy and can swallow pills. They must use effective contraception if of childbearing potential and have good organ function. Excluded are those with other cancers, certain infections or severe medical conditions, pregnancy, known allergies to abemaciclib components, or prior CDK4/6 inhibitor treatment.Check my eligibility
What is being tested?
The trial is testing the effectiveness of abemaciclib versus a placebo in treating grade 3 meningioma after standard radiation therapy. It's randomized and double-blinded; neither participants nor researchers know who receives the actual drug or placebo.See study design
What are the potential side effects?
While not specified here, common side effects of drugs like abemaciclib may include diarrhea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, liver issues, and possible allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer test shows positive for RB protein or no RB gene mutations.
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I can swallow pills.
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I can do most of my daily activities by myself.
Select...
I am 18 years old or older.
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I am not pregnant or cannot become pregnant due to menopause or surgery.
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My meningioma is WHO Grade 3 or has progressed to this grade after radiation therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival
Secondary outcome measures
Adverse Events
Deaths
Drug-related toxicity
+4 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
Placebo Group
Group I: Active Treatment (Abemaciclib)Experimental Treatment1 Intervention
Administered twice daily on days 1-28 of each 28-day cycle.
Group II: PlaceboPlacebo Group1 Intervention
Administered twice daily on days 1-28 of each 28-day cycle.
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?
Ivy Brain Tumor CenterOTHER
10 Previous Clinical Trials
305 Total Patients Enrolled
1 Trials studying Meningioma
48 Patients Enrolled for Meningioma
Nader SanaiLead Sponsor
8 Previous Clinical Trials
256 Total Patients Enrolled
1 Trials studying Meningioma
48 Patients Enrolled for Meningioma
Barrow Neurological InstituteOTHER
24 Previous Clinical Trials
6,991 Total Patients Enrolled
1 Trials studying Meningioma
48 Patients Enrolled for Meningioma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can understand and am willing to sign the consent form myself or through a legal representative.You have had allergic reactions to any of the ingredients in abemaciclib.I am currently using a coumarin-based blood thinner.My cancer test shows positive for RB protein or no RB gene mutations.I have recovered from my last radiation therapy, which was between 2 to 5 weeks ago.I haven't needed antibiotics or antivirals for an infection or high fever in the last 4 weeks.I can swallow pills.I have been treated with a CDK4/6 inhibitor before.I have a history of serious heart conditions, including fainting due to heart issues, dangerous irregular heartbeats, or sudden cardiac arrest.I am a man who can father children and will use contraception during and for 3 weeks after treatment.I can do most of my daily activities by myself.I am 18 years old or older.My bone marrow and organs are functioning well.I am not pregnant or cannot become pregnant due to menopause or surgery.I am currently being treated for another cancer.I do not have severe infections, serious liver disease, or active hepatitis.I do not have any active infections.My meningioma is WHO Grade 3 or has progressed to this grade after radiation therapy.
Research Study Groups:
This trial has the following groups:- Group 1: Active Treatment (Abemaciclib)
- Group 2: Placebo
Awards:
This trial has 0 awards, including: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 the enrollment period for this experiment still open?
"According to the clinicaltrials.gov website, this trial is not currently recruiting participants and has been inactive since July 4th 2023. Nonetheless, there are still 45 other trials actively seeking volunteers at this time."
Answered by AI
To what extent could Abemaciclib present a hazard to patients?
"After a thorough evaluation, our team determined that Active Treatment (Abemaciclib) is likely safe and gave it a score of 2. This appraisal was reached due to the existence of Phase 2 trial data which demonstrated acceptable risk profiles but has yet to show efficacy."
Answered by AI
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