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CDK4/6 Inhibitor
Ribociclib for Brain Cancer
Phase < 1
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 22, 43, 64 (add 21 day intervals)...until disease returns or side effect preventing participation in study occurs
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group
Summary
This trial will test the effects of the drug ribociclib on patients with brain tumors. Patients will take the drug prior to surgery and will be enrolled sequentially (not randomly).
Who is the study for?
Adults with recurrent glioma or meningioma who've had one prior surgery, can sign consent, and meet specific lab criteria. They must not have used ribociclib before, have other recent cancers (except certain skin/cervical cancers), significant heart issues, uncontrolled medical conditions, known hypersensitivity to ribociclib's components or be pregnant/nursing.
What is being tested?
The trial tests Ribociclib given orally in 5 doses before tumor removal surgery. Patients are enrolled sequentially based on time intervals rather than randomized. The last dose is timed at one of three set periods before the operation.
What are the potential side effects?
Potential side effects of Ribociclib may include blood count changes, liver function alterations, fatigue, nausea and vomiting. It could also affect heart rhythm and cause QT prolongation which is a measure of delayed heart electrical activity.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1, 22, 43, 64 (add 21 day intervals)...until disease returns or side effect preventing participation in study occurs
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 22, 43, 64 (add 21 day intervals)...until disease returns or side effect preventing participation in study occurs
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Brain
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Administration of ribociclibExperimental Treatment1 Intervention
Subjects will be administered ribociclib prior to surgical resection of their tumor. All patients will be orally-administered 5 doses of LEE011 (900 mg/d) with the final dose occurring at one of 3 following intervals before brain tumor resection:
Cohort 1: last ribociclib dose 2-4 hours prior to craniotomy for tumor resection
Cohort 2: last ribociclib dose 6-8 hours prior to craniotomy for tumor resection
Cohort 3: last ribociclib dose 23-25 hours prior to craniotomy for tumor resection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribociclib
FDA approved
Find a Location
Who is running the clinical trial?
NovartisIndustry Sponsor
1,636 Previous Clinical Trials
2,773,559 Total Patients Enrolled
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231 Patients Enrolled for Meningioma
Ivy Brain Tumor CenterOTHER
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791 Total Patients Enrolled
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Barrow Neurological InstituteOTHER
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2 Trials studying Meningioma
80 Patients Enrolled for Meningioma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of being infected with HIV.You have been treated with ribociclib before.You have had another type of cancer within the past 3 years, except for certain types of skin cancer or cervical cancer that has been successfully treated.You have been diagnosed with a heart muscle disease called cardiomyopathy.Your heart's pumping ability, as measured by a special heart test, is less than 50%.You have serious heart rhythm problems or blockages in your heart's electrical system.The tumor does not have a positive Rb status.You currently have a fever or an active infection.You are allergic to any of the ingredients in ribociclib.You have a condition in your stomach or intestines that could make it hard for your body to absorb the study drugs. This includes things like severe ulcers, uncontrolled nausea, vomiting, or diarrhea, and problems with absorbing nutrients from food.You have serious heart problems that are not being controlled.You have had a heart attack, unstable angina, or other serious heart problems within the past 6 months.You have been diagnosed with severe congestive heart failure.You are 18 years old or older.You have a history of heart rhythm problems, or are taking certain medications that can affect your heart rhythm, or have high or low blood pressure.You must have recovered from any side effects of previous cancer treatments, except for hair loss.Evidence from an MRI showing that the disease has come back.For brain tumors, the tissue sample must show specific genetic characteristics related to the RB gene or certain genetic deletions and amplifications.You have had surgery to remove a specific type of brain tumor in the past.You are able to perform daily activities with little or no assistance.You are allergic to peanuts, soy, or lactose.If you have meningioma, the tissue sample must show that the RB protein is present, or genetic testing must show no mutations in the RB gene.Before joining the study, your blood counts, electrolytes, kidney and liver function, and heart's electrical activity must be within a certain range. You also need to be able to swallow the study medication, and if you're taking certain other treatments, you need to stop them for a specific period before starting the study.
Research Study Groups:
This trial has the following groups:- Group 1: Administration of ribociclib
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
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