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CDK4/6 Inhibitor

Ribociclib for Brain Cancer

Phase < 1
Waitlist Available
Led By Nader Sanai, MD
Research Sponsored by Nader Sanai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 22, 43, 64 (add 21 day intervals)...until disease returns or side effect preventing participation in study occurs
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial will test the effects of the drug ribociclib on patients with brain tumors. Patients will take the drug prior to surgery and will be enrolled sequentially (not randomly).

Who is the study for?
Adults with recurrent glioma or meningioma who've had one prior surgery, can sign consent, and meet specific lab criteria. They must not have used ribociclib before, have other recent cancers (except certain skin/cervical cancers), significant heart issues, uncontrolled medical conditions, known hypersensitivity to ribociclib's components or be pregnant/nursing.
What is being tested?
The trial tests Ribociclib given orally in 5 doses before tumor removal surgery. Patients are enrolled sequentially based on time intervals rather than randomized. The last dose is timed at one of three set periods before the operation.
What are the potential side effects?
Potential side effects of Ribociclib may include blood count changes, liver function alterations, fatigue, nausea and vomiting. It could also affect heart rhythm and cause QT prolongation which is a measure of delayed heart electrical activity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 22, 43, 64 (add 21 day intervals)...until disease returns or side effect preventing participation in study occurs
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 22, 43, 64 (add 21 day intervals)...until disease returns or side effect preventing participation in study occurs for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Brain

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Administration of ribociclibExperimental Treatment1 Intervention
Subjects will be administered ribociclib prior to surgical resection of their tumor. All patients will be orally-administered 5 doses of LEE011 (900 mg/d) with the final dose occurring at one of 3 following intervals before brain tumor resection: Cohort 1: last ribociclib dose 2-4 hours prior to craniotomy for tumor resection Cohort 2: last ribociclib dose 6-8 hours prior to craniotomy for tumor resection Cohort 3: last ribociclib dose 23-25 hours prior to craniotomy for tumor resection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribociclib
FDA approved

Find a Location

Who is running the clinical trial?

NovartisIndustry Sponsor
1,639 Previous Clinical Trials
2,774,255 Total Patients Enrolled
6 Trials studying Meningioma
231 Patients Enrolled for Meningioma
Ivy Brain Tumor CenterOTHER
11 Previous Clinical Trials
791 Total Patients Enrolled
1 Trials studying Meningioma
72 Patients Enrolled for Meningioma
Barrow Neurological InstituteOTHER
26 Previous Clinical Trials
6,987 Total Patients Enrolled
2 Trials studying Meningioma
80 Patients Enrolled for Meningioma
Nader SanaiLead Sponsor
8 Previous Clinical Trials
280 Total Patients Enrolled
1 Trials studying Meningioma
72 Patients Enrolled for Meningioma
Nader Sanai, MDPrincipal Investigator - Deputy Director of the Ivy Brain Tumor Center
Barrow Neurological Institute at St. Joseph's, Chandler Regional Medical Center, Select Specialty Hospital-Phoenix, St. Joseph's Hospital & Medical Center
University Of California (Medical School)
University Ca Sf School Of Medicine (Residency)
13 Previous Clinical Trials
971 Total Patients Enrolled
1 Trials studying Meningioma
72 Patients Enrolled for Meningioma

Media Library

Ribociclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02933736 — Phase < 1
Meningioma Research Study Groups: Administration of ribociclib
Meningioma Clinical Trial 2023: Ribociclib Highlights & Side Effects. Trial Name: NCT02933736 — Phase < 1
Ribociclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02933736 — Phase < 1
~5 spots leftby Dec 2025