Ribociclib (LEE011) in Preoperative Glioma and Meningioma Patients

Running, not enrolling · Early Phase 1

Conditions studied: Glioblastoma Multiforme, Meningioma

In brief

In the proposed trial, patients will be administered ribociclib prior to surgical resection of their tumor. Patients will be enrolled in time-intervals sequentially (non-randomized). All patients will be orally-administered 5 doses of LEE011 (900 mg/d) with the final dose occurring at one of 3 intervals before brain tumor resection.

Key facts

Study ID

NCT02933736

Run by

Nader Sanai

People needed

48

Starts

2016-10-17

Expected to finish

2027-03-01

Last updated by the study team

2026-03-06

Who can join

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

You may qualify if…

• One prior resection of histologically-diagnosed World Health Organization (WHO) Grade III or IV glioma, or WHO grade II or III meningioma.
• MRI evidence of disease recurrence
• For gliomas, archival tissue must demonstrate: (a) RB positivity on immunohistochemistry OR no RB mutations on next-gen sequencing (NGS), (b) Chromosome 9p21.3 deletion on FISH OR CDKN2A/B/C loss on array CGH OR CDK4/6 or CCND1/2 amplification on array CGH.
• For meningiomas, archival tissue much demonstrate (a) RB positivity on immunohistochemistry OR no RB mutations on next-gen sequencing (NGS).
• Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• Patients ≥ 18 years of age
• Ability to understand and the willingness to sign a written informed consent document (personally or by the legally authorized representative, if applicable).
• Patient has voluntarily agreed to participate by giving written informed consent (personally or via legally-authorized representative(s), and assent if applicable).
• (Written informed consent for the protocol must be obtained prior to any screening procedures. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.)
• Patients must have recovered from all toxicities related to prior anticancer therapies to ≤ grade 2 (CTCAE v 4.03), provided that concomitant medication is given prior to initiation of treatment with ribociclib. Exception to this criterion: patients with any grade of alopecia are allowed to enter the treatment.
• The following laboratory criteria have been met:
• Absolute neutrophil count (ANC) ≥1.5 x 109/L
• Hemoglobin (Hgb) ≥ 9 g/dL
• Platelets ≥100 x 10\^9/L
• Potassium, total calcium (corrected for serum albumin), magnesium, and sodium within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication.
• INR ≤1.5
• Serum creatinine < 1.5 mg/dL or creatinine clearance ≥ 50 mL/min
• In the absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN.
• Serum total bilirubin < ULN, or < 3.0 x ULN in patients with well-documented Gilbert's syndrome.
• Patient with available standard 12-lead ECG with the following parameters at screening (defined as the mean of the ECGs):
• QTcF interval at screening < 450 msec (using Fridericia's correction)
• Resting heartrate 50-90 bpm
• Must be able to swallow ribociclib capsules/tablets
• If patient is receiving tamoxifen or toremifene, a washout period of 5 half-lives prior to enrollment is required

You may not qualify if…

• Archival tissue not available for research use.
• Archival tumor not Rb-positive status
• No prior radiotherapy
• Co-morbid condition(s) that, at the opinion of the investigator, prevent safe surgical treatment
• Active infection or fever > 38.5°C
• Patients with known hypersensitivity to any of the excipients of ribociclib
• Patients with known hypersensitivity to peanut, soy or lactose
• Prior therapy with ribociclib.
• Patient has a concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
• History of HIV infection (testing not mandatory).
• Other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol.
• Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormalities.
• History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 6 months prior to screening
• History of documented congestive heart failure (New York Heart Association functional classification III-IV)
• Documented cardiomyopathy
• Left Ventricular Ejection Fraction (LVEF) <50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO) at screening
• Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g. bifascicular block, Mobitz type II and third-degree AV block)
• Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
• Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia.
• Concomitant use of medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued (within 5 half-lives or 7 days prior to starting study drug) or replaced by safe alternative medication
• Inability to determine the QT interval on screening (QTcF, using Fridericia's correction)
• Systolic blood pressure (SBP) >160 mmHg or <90 mmHg at screening
• Currently receiving any of the following medications and cannot be discontinued 7 days prior to starting study drug:
• Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pomelos/pummelos, star-fruit, pomegranates or pomegranate juice and Seville oranges

Where it is running

• Barrow Brain and Spine — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.