Clinical Trial

Ribociclib (LEE011) in Preoperative Glioma and Meningioma Patients

Active, Not Recruiting Early Phase 1
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Summary
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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2016-10-12; most recent amendment 2026-03-04.
Status change: Recruiting → Active, Not Recruiting 2023-03-06
Trial Details
NCT Number NCT02933736
Lead Sponsor Nader Sanai
Collaborators: Novartis, Ivy Brain Tumor Center, Barrow Neurological Institute
Conditions Glioblastoma Multiforme, Meningioma
Enrollment 48 participants
Start Date 2016-10-17
Primary Completion 2023-03-01 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-03-06