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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will test the effects of abemaciclib on patients with recurrent brain tumors.

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.Check my eligibility

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.See study design

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 below

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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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

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 (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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,558 Total Patients Enrolled

Eli Lilly and CompanyIndustry Sponsor

2,615 Previous Clinical Trials

3,200,994 Total Patients Enrolled

Thomas Kaley, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

8 Previous Clinical Trials

294 Total Patients Enrolled

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03220646 — Phase 2

Brain Tumor Research Study Groups: C:All other recurrent brain tumors, A:recurrent IDH wildtype RB1 intact grade II and III gliomas, B:Recurrent glioma any grade

Brain Tumor Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT03220646 — Phase 2

Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03220646 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is abemaciclib a reliable remedy for patients?

"Abemaciclib has demonstrated some safety, so it received a rating of 2. As this is an early stage trial with no evidence yet on efficacy, the score reflects that lack of data."

Answered by AI

How wide a scope does this research cover?

"Nine clinical trial sites are available, such as the Hartford Healthcare Cancer Institute @ Hartford Hospital in Middletown, Memorial Sloan Kettering Monmouth (All Protocol Activities)in Allentown and Lehigh Valley Health Network in Montvale. Other options exist too."

Answered by AI

How many participants are actively engaged in this clinical research?

"This clinical trial has ended its recruitment phase, with the first posting on July 13th 2017 and last update occuring on March 30th 2022. Other studies related to neoplasms or abemaciclib may interest you -- as of now there are 408 trials involving brain tumors and 92 involving abemaciclib actively recruiting patients."

Answered by AI

Are there any records of past experiments with abemaciclib?

"Abemaciclib was first researched back in 2009, and there are currently 31 completed trials. There are 92 studies being conducted as of now, with many based out of Middletown, NJ. For more information regarding these clinical sites or for general enquiries about the trial feel free to contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) during the business week from 9am till 5pm Eastern Time (UTC/GMT -5 hours EST)."

Answered by AI

What malady is abemaciclib typically employed to combat?

"Abemaciclib can be utilized to treat higher risk cases of recurrent, human epidermal growth factor receptor 2 (HER2) negative, advanced hormone-receptor positive breast cancer and endocrine therapy."

Answered by AI

Has recruitment opened for this research endeavor?

"This trial is not currently accepting enrolments. It was first listed on July 13th 2017 and its last update occured March 30th 2022. However, if you are in search of other studies, there are 408 trials for neoplasms and 92 clinical trails for abemaciclib which remain active."

Answered by AI

Is this the inaugural investigation of its kind?

"Abemaciclib has been the subject of research since its initial study in 2009, which was conducted by Eli Lilly and Company. This early Phase 1 trial included 220 patients and eventually led to FDA drug approval for abemaciclib. Presently there are 92 trials underway across a range of 41 nations and 1276 cities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Abemaciclib (LY2835219) in Patients With Recurrent Primary Brain Tumors

2017. "Abemaciclib (LY2835219) in Patients With Recurrent Primary Brain Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03220646.

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