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Abemaciclib (LY2835219) in Patients With Recurrent Primary Brain Tumors | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Abemaciclib (LY2835219) in Patients With Recurrent Primary Brain Tumors

A Phase 2 Study of Abemaciclib in Patients With Recurrent Primary Brain Tumors

NCT03220646•Memorial Sloan Kettering Cancer Center

Summary

The purpose of this study is to test any good and bad effects of a study drug called abemaciclib (LY2835219) in patients with recurrent brain tumors.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Cohort A specific inclusion:
•Histologically confirmed IDHwt, RB intact, grade II or III glioma that has recurred after first line therapy (consisting of at least maximum feasible surgical resection and radiation therapy). There is no limit on the number of prior therapies or types of therapies patients can have received.
•Measurable disease on imaging (1cm) or measurable non-enhancing tumor.
•At least 12 weeks elapsed since prior radiotherapy
•Cohort B specific inclusion:
•Patients with histologically confirmed glioma of any grade (II-IV) who are planned for a standard of care surgical debulking/resection and for whom participation in this study would not cause a medically unacceptable delay in surgery.
•Patients must have relapsed/progressed following therapy (consisting of at least maximum feasible surgical resection and radiation therapy).
•Cohort C specific Inclusion:
•Histologically confirmed IDH mutant glioma, meningioma, schwanomma, PCNSL, ependymoma, or other Primary Brain Tumors that have recurred despite previous standard of care therapy. Because this cohort is, in part, meant to allow patients access to therapy who might not otherwise be eligible for other clinical trials - deviations from standard of care treatment or histological confirmation can be presented to and approved by the Principal Investigator for inclusion in the study.
•Histologically confirmed PCNSL that has recurred after prior methotrexate-based chemotherapy or for whom methotrexate-based chemotherapy is deemed medically not in the patient's best interest.
+23 more criteria

Exclusion Criteria

•No limit on number of prior therapies
•Evidence of significant intracranial hemorrhage
•No other investigational or standard anti-tumor therapy allowed
•Patients must not have a known history of allergic reactions attributed to compounds of similar chemical or biologic composition.
•Patients must not have a serious preexisting medical condition(s) or uncontrolled intercurrent illness that would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea) or psychiatric illness/social situations that would limit compliance with study requirements.
•Patients who have a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological original (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.
•HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions. This applies only to patients who have a documented history of HIV; HIV testing is not otherwise required.
•Have an active systemic fungal and/or known viral infection (for example, human immunodeficiency virus antibodies, hepatitis B surface antigen, or hepatitis C antibodies)
•Patients must not be on EIAEDs
•Females who are pregnant or lactating
+3 more criteria

Locations (8)

Hartford Healthcare Cancer Institute @ Hartford Hospital (Data collection only)

Hartford, Connecticut, United States

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack (All Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Lehigh Valley Health Network

Allentown, Pennsylvania, United States

Key Dates

Start Date

July 13, 2017

Primary Completion Date

July 1, 2026

Completion Date

July 1, 2026

Last Updated

July 9, 2025

Enrollment

ACTUAL participants

Conditions

Brain Tumor

Interventions

abemaciclib

DRUG

abemaciclib

DRUG

Targeted Pediatric High-Grade Glioma Therapy

NCT05839379

High Grade GliomaDiffuse Intrinsic Pontine Glioma+7 more

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The Impact of Paramedic Training in Simulation on the Experience of Patients Treated for Malignant Brain Tumors in Neurosurgery (IPSIMANON)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Abemaciclib (LY2835219) in Patients With Recurrent Primary Brain Tumors

Inclusion Criteria

Exclusion Criteria

Targeted Pediatric High-Grade Glioma Therapy

The Impact of Paramedic Training in Simulation on the Experience of Patients Treated for Malignant Brain Tumors in Neurosurgery (IPSIMANON)

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