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Brain TumorPhase 2NCT03220646

Abemaciclib (LY2835219) in Patients With Recurrent Primary Brain Tumors

A Phase 2 study testing abemaciclib in people with Brain Tumor, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Tumor
What is being tested?
abemaciclib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
8 sitesUnited States
Study dates
13 Jul 2017to Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.
  • 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.
  • All cohorts:
  • Patients must provide written informed consent prior to any screening procedures.
  • Age 18 years or older.
  • KPS ≥ 60
  • Willing and able to comply with scheduled visits, treatment plan and laboratory tests
  • Patient is able to swallow and retain oral medication
  • Required baseline laboratory status:
  • Hemoglobin > 8 g/dL (SI Units: 80 g/L). Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion.
  • Platelet count ≥ 100 x 10^9/L
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L without growth factor support
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
  • AST/SGOT and/or ALT/SGPT ≤ 3 x ULN
  • Serum Creatinine ≤ 1.5 x ULN
  • Stable dose of corticosteroids for > 5 days prior to baseline MRI
  • Before starting study treatment, patients must have recovered from toxic effects of prior therapies (except for residual alopecia or Grade 2 peripheral neuropathy) and at least 3 weeks must have elapsed since any prior signaling pathway modulators, (e.g., EGFR, FGFR, or other tyrosine kinase inhibitors), at least 3 weeks must have elapsed since temozolomide, 4 weeks must have elapsed since carboplatin or cisplatin, and at least 6 weeks from nitrosoureas (e.g., BCNU, CCNU). In general, at least 4 weeks must have elapsed from any other anticancer drug therapy (e.g. bevacizumab).
  • Patients must be able to undergo contrast enhanced MRI scans (or contrast enhanced CT scans for patients unable to tolerate MRI).
  • Patients must have shown unequivocal evidence for tumor progression by MRI (or CT for patients who cannot tolerate MRI) in comparison to a prior scan. The same type of scan, i.e., MRI (or CT for patients who cannot undergo MRI) must be used throughout the period of protocol treatment for tumor measurement.
  • Life expectancy of greater than 8 weeks
  • If a female of childbearing potential, must have a negative serum pregnancy test within 7 days of the first dose of abemaciclib and agree to use a medically approved contraceptive method during the treatment period and for 3 months following the last dose of abemaciclib. If a male, agree to use a reliable method of birth control and to not donate sperm during the treatment period and for at least 3 months following the last dose of abemaciclib. Contraceptive methods may include an intrauterine device [IUD] or barrier method. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection.
  • Note: Cases of pregnancy that occur during maternal exposures to abemaciclib should be reported. If a patient or spouse/partner is determined to be pregnant following abemaciclib initiation, she must discontinue treatment immediately. Data on fetal outcome and breast-feeding are collected for regulatory reporting and drug safety evaluation.
  • Women must agree not to breast feed while on abemaciclib treatment and for at least three months following the last dose of study therapy.

Who cannot join

  • 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.
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  • 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
  • Must abstain from grapefruit juice
  • Patients must not have other active concurrent malignancy
  • Concurrent treatment on another clinical trial. Supportive care trials or non-therapeutic trials (i.e. Quality of life) are allowed.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

    Basking Ridge, New Jersey, 07920

  • Memorial Sloan Kettering Commack (All Protocol Activities)

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    Harrison, New York, 10604

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

    Hartford, Connecticut, 06102

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    Montvale, New Jersey, 07645

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York, 10065

Other trials in United States

About this study

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

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.

Conditions
Brain Tumor
Being tested
abemaciclib
Keywords
Abemaciclib (LY2835219), meningioma, Astrocytoma, ependymoma, Oligodendroglioma, CNS lymphoma, 17-261
Medical subject headings
Brain Neoplasms, Meningioma, Astrocytoma, Ependymoma, Oligodendroglioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • abemaciclibDrug

    abemaciclib 200mg PO q12 hours (+/- 2 hours) on days 1-28 of each 28 day cycle.

  • abemaciclibDrug

    200mg PO q12 hours (+/- 2 hours) for 4-7 days prior to surgery. Upon recovery from surgery, patients will resume abemaciclib at the same dose and schedule as cohorts A and C.

Study groups in NCT03220646
Study groupRoleWhat they receive
A:recurrent IDH wildtype RB1 intact grade II and III gliomasExperimentalThe 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.
Receives: Drug: abemaciclib
B:Recurrent glioma any gradeExperimentalTen 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.
Receives: Drug: abemaciclib
C:All other recurrent brain tumorsExperimentalThis is an exploratory cohort including patients with recurrent IDH mutant glioma, meningioma, recurrent ependymoma, and recurrent PCNSL,and other primary brain tumors.
Receives: Drug: abemaciclib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. radiographic response rate

    MRI (or CT) scan by RANO criteria.

    Measured: 6 months

  2. progression free survival (PFS)

    will be estimated by the Kaplan Meier method

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2017
  2. Study start13 Jul 2017
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Model description
This is an open-label, non-randomized, phase II trial of single-agent abemaciclib administered at previously defined MTD/RP2D in three cohorts of patients with primary brain tumors.
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03220646
Sponsor's protocol ID
17-261
Status last verified
Jul 2026
First submitted
14 Jul 2017
Last updated
10 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Kaley TJ, Grommes C, Coffee E, Young RJ, Morrison T, Daher A, Schaff LR, Deng Y, Nandakumar S, Diamond EL, DeAngelis LM, Panageas KS, Gavrilovic I, Lin A, Pentsova E, Stone J, Santomasso BD, Piotrowski AF, Nair S, Schultz N, Reiner AS, Mellinghoff IK. Multicenter basket trial for central nervous system tumors identifies activity of the CDK4/6 inhibitor abemaciclib in recurrent meningioma. Neuro Oncol. 2025 Dec 1;27(12):3189-3199. doi: 10.1093/neuonc/noaf184.

    PubMed 40842355

  • Yang C, Ren X, Cui Y, Jiang H, Li M, Yu K, Shen S, Li M, Zhang X, Zhao X, Zhu Q, Bu X, Lin S. New hopes and challenges in targeted therapy and immunotherapy for primary central nervous system lymphoma. Front Immunol. 2025 Feb 18;16:1438001. doi: 10.3389/fimmu.2025.1438001. eCollection 2025.

    PubMed 40040699

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing abemaciclib in people with Brain Tumor, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

radiographic response rate (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03220646, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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