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mTOR Inhibitor

Ribociclib for Glioblastoma

Phase < 1
Waitlist Available
Led By Nader Sanai, MD
Research Sponsored by St. Joseph's Hospital and Medical Center, Phoenix
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 from date of the first phase 2 dose until the first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Awards & highlights

Study Summary

A Phase 0 /II Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection

Eligible Conditions
  • Glioblastoma
  • Brain Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of the first phase 2 dose until the first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of the first phase 2 dose until the first documented progression or date of death from any cause, whichever came first, assessed up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MTD: highest dose of drug that did not cause a DLT in > 33% of participants
Median concentration of ribociclib and everolimus for all patients for unbound plasma, CSF, Unbound NE, Unbound enhancing (2-24H post last dose)
Pharmacokinetic analysis - Total Ribociclib and Everolimus T1/2 (0-24)
+6 more
Secondary outcome measures
Median Overall Survival (OS) from time of surgery to date of recurrence in Phase 2 patients
Median concentration of trough plasma concentrations of Total Ribociclib and Total Everolimus in Phase 2
Median progression-free survival (PFS) from time of surgery to date of recurrence in Phase 2 patients
+1 more
Other outcome measures
The median percentage of CDK4/6 and mTOR pathway active cells compared to baseline (total and phosphorylated forms of Rb, FoxM1, S6, 4EBP, as well as cleaved Caspase-3 and MIB1. Expression of Cyclin D1, Cyclin E1, PI3K/mTOR signaling components)

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 3: last dose 23 to 25 hours prior to resectionExperimental Treatment2 Interventions
Three to fourteen patients will receive ribociclib and everolimus orally-administered in 5 daily doses with the last dose being administered at one of 3 intervals before brain tumor resection: • Cohort 3: last ribociclib+everolimus dose 23 to 25 hours prior to craniotomy for tumor resection
Group II: Cohort 2: last dose 7 to 9 hours prior to resectionExperimental Treatment2 Interventions
Three to fourteen patients will receive ribociclib and everolimus orally-administered in 5 daily doses with the last dose being administered at one of 3 intervals before brain tumor resection: • Cohort 2: last ribociclib+everolimus dose 7 to 9 hours prior to craniotomy for tumor resection
Group III: Cohort 1: last dose 1 to 3 hours prior to resectionExperimental Treatment2 Interventions
Three to fourteen patients will receive ribociclib and everolimus orally-administered in 5 daily doses with the last dose being administered at one of 3 intervals before brain tumor resection: • Cohort 1: last ribociclib+everolimus dose 1 to 3 hours prior to craniotomy for tumor resection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribociclib
2018
Completed Phase 3
~2330
Everolimus
2010
Completed Phase 4
~1510

Find a Location

Who is running the clinical trial?

Ivy Brain Tumor CenterOTHER
10 Previous Clinical Trials
350 Total Patients Enrolled
7 Trials studying Glioblastoma
226 Patients Enrolled for Glioblastoma
Barrow Neurological InstituteOTHER
24 Previous Clinical Trials
7,036 Total Patients Enrolled
7 Trials studying Glioblastoma
226 Patients Enrolled for Glioblastoma
St. Joseph's Hospital and Medical Center, PhoenixLead Sponsor
63 Previous Clinical Trials
14,678 Total Patients Enrolled
6 Trials studying Glioblastoma
304 Patients Enrolled for Glioblastoma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Phase 0 /II Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection
2018. "A Phase 0 /II Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03834740.
~4 spots leftby Apr 2025
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