Ribociclib (LEE011) in Preoperative Glioma and Meningioma Patients
NCT02933736 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2026-03-06
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.
Conditions
- Glioblastoma Multiforme
- Meningioma
Interventions
- DRUG
Sponsors & Collaborators
- collaborator INDUSTRY
-
Ivy Brain Tumor Center
collaborator OTHER -
Barrow Neurological Institute
collaborator OTHER -
Nader Sanai
lead OTHER
Principal Investigators
-
Nader Sanai, MD · Deputy Director of the Ivy Brain Tumor Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-17
- Primary Completion
- 2023-03-01
- Completion
- 2027-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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