Abemaciclib (LY2835219) in Patients With Recurrent Primary Brain Tumors

Running, not enrolling · Phase 2

Conditions studied: Brain Tumor

In brief

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.

Key facts

Study ID

NCT03220646

Run by

Memorial Sloan Kettering Cancer Center

People needed

64

Starts

2017-07-13

Expected to finish

2027-07-01

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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