Could a cancer drug shrink recurrent brain tumors?
NCT ID NCT03220646
First seen Jul 10, 2026 · Last updated Jul 10, 2026
Summary
This phase 2 trial is testing the drug abemaciclib in people whose primary brain tumors have come back after initial treatment. The goal is to see if the drug can shrink tumors or slow their growth. Participants take abemaciclib pills twice daily, and some take it before surgery to study its effects on tumor tissue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- abemaciclib
- What this could lead to
- If effective, abemaciclib could offer a new treatment option for patients with recurrent brain tumors, potentially shrinking tumors or delaying further growth.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not apply broadly. The drug may cause side effects or fail to show benefit.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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64 people
The number who actually took part.
- Started
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Jul 2017
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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. 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. 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 * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hartford Healthcare Cancer Institute @ Hartford Hospital (Data collection only)
Hartford, Connecticut, 06102, United States
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Lehigh Valley Health Network
Allentown, Pennsylvania, 18103, United States
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Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack (All Protocol Activities)
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604, United States
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