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CDK4/6 Inhibitor
Abemaciclib for Brain Cancer
Phase 2
Waitlist Available
Led By Thomas Kaley, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Glioma patients: Standard of care next generation sequencing via a CLIA certified platform must be available, or planned and at a minimum include IDH, and RB status
Patients must be able to undergo contrast enhanced MRI scans (or contrast enhanced CT scans for patients unable to tolerate MRI) and have shown unequivocal evidence for tumor progression by MRI (or CT for patients who cannot tolerate MRI) in comparison to a prior scan
Must not have
Personal history of syncope of cardiovascular etiology, ventricular arrhythmia of pathological original, or sudden cardiac arrest
HIV-positive patients on combination antiretroviral therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Summary
This trial is testing a drug called abemaciclib in patients whose brain tumors have come back after treatment. The drug aims to stop the growth of cancer cells by blocking certain proteins that help them multiply. Researchers want to see both the positive and negative effects of this treatment. Abemaciclib is used primarily for treating metastatic breast cancer.
Who is the study for?
This trial is for adults with recurrent brain tumors, specifically IDH wildtype and RB intact gliomas or other primary brain tumors. Participants must have had prior therapy, be able to swallow pills, consent to use birth control, and not be on certain medications or have specific health conditions that could interfere with the study.
What is being tested?
The trial is testing abemaciclib (LY2835219) effects on patients with recurrent brain tumors. It aims to understand both the potential benefits and adverse reactions of this drug in individuals who have seen their tumor return after initial treatment.
What are the potential side effects?
While not explicitly listed here, side effects may include typical reactions to cancer drugs such as nausea, fatigue, blood count changes, liver function alterations, and potential risks related to fertility for both men and women.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My glioma has been or will be tested for specific genetic changes.
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I can have MRI or CT scans, and my scans show my tumor is growing.
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I have a glioma that has worsened after treatment and am scheduled for surgery.
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I am over 18, can take pills, follow a treatment plan, and my lab results meet the study's needs.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.
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I am HIV-positive and on antiretroviral therapy.
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I am taking enzyme-inducing anti-epileptic drugs.
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I am not pregnant or breastfeeding.
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I do not have any other active cancer.
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I am not currently receiving any other cancer treatment.
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I have an active fungal or viral infection.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
progression free survival (PFS)
radiographic response rate
Trial Design
3Treatment groups
Experimental Treatment
Group I: C:All other recurrent brain tumorsExperimental Treatment1 Intervention
This is an exploratory cohort including patients with recurrent IDH mutant glioma, meningioma, recurrent ependymoma, and recurrent PCNSL,and other primary brain tumors.
Group II: B:Recurrent glioma any gradeExperimental Treatment1 Intervention
Ten patients who require standard of care cytoreductive surgery for recurrent astrocytoma, oligodendroglioma, or glioblastoma, will be offered pre-surgical abemaciclib and then resume the drug following recovery from surgery, continuing until disease progression or unacceptable toxicity analogous to the non-surgical patients in cohort A and C. This arm is closed to accrual.
Group III: A:recurrent IDH wildtype RB1 intact grade II and III gliomasExperimental Treatment1 Intervention
The main study cohort will consist of patients with recurrent IDH wildtype, RB1 wildtype, WHO grade II and III gliomas that have failed previous therapy. This arm is currently on hold.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for brain tumors include chemotherapy, radiation therapy, and targeted therapies such as CDK4/6 inhibitors. Chemotherapy, like temozolomide, works by damaging the DNA of cancer cells, preventing their replication.
Radiation therapy uses high-energy rays to kill or damage cancer cells in a targeted area. CDK4/6 inhibitors, such as Abemaciclib, block proteins (CDK4 and CDK6) that are essential for cell division, thereby slowing the growth of cancer cells.
These treatments are crucial for brain tumor patients as they target the rapid and uncontrolled cell division characteristic of tumors, potentially improving survival rates and quality of life.
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,960 Previous Clinical Trials
596,663 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,651 Previous Clinical Trials
3,224,403 Total Patients Enrolled
Thomas Kaley, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
8 Previous Clinical Trials
294 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had multiple treatments for my condition.You cannot drink grapefruit juice while participating in the study.You are expected to live for more than 8 weeks.I have a history of fainting due to heart issues, irregular heartbeats, or sudden cardiac arrest.I am HIV-positive and on antiretroviral therapy.I am taking enzyme-inducing anti-epileptic drugs.I am not pregnant or breastfeeding.My brain tumor has returned despite treatment and is IDH mutant.My glioma has been or will be tested for specific genetic changes.I can have MRI or CT scans, and my scans show my tumor is growing.I am not on another treatment trial, but I may be in a supportive care or quality of life study.I am not pregnant and agree to use birth control during and 3 months after treatment.I do not have any other active cancer.You have a serious bleeding in your brain.You have had allergic reactions to similar drugs or substances in the past.I have recovered from side effects of my previous cancer treatments.I have a glioma that has worsened after treatment and am scheduled for surgery.I am not currently receiving any other cancer treatment.My grade II or III glioma has returned after first treatment, and it's been 12 weeks since my last radiotherapy.I am over 18, can take pills, follow a treatment plan, and my lab results meet the study's needs.I have an active fungal or viral infection.
Research Study Groups:
This trial has the following groups:- Group 1: C:All other recurrent brain tumors
- Group 2: A:recurrent IDH wildtype RB1 intact grade II and III gliomas
- Group 3: B:Recurrent glioma any grade
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.
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