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

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 up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

In the proposed trial, patients will be administered ribociclib+everolimus prior to surgical resection of their tumor. Recurrent GBM patients will be randomized into one of the three time-interval cohorts for the first two dose levels. In the lead-in dose escalation study, the first six subjects (lead-in) will receive ribociclib 400 mg and everolimus 2.5 mg orally-administered in 5 daily doses with the last dose. If one or less patient experiences DLT among the 6 patients, this regimen with ribociclib 400 mg and everolimus 2.5mg will be considered safe and we will continue with the dose escalation phase of the study up to Level 3. Four dose escalation levels: Level 0: ribociclib 400mg and everolimus 2.5 Level 1: ribociclib 600mg and everolimus 2.5mg Level 2: ribociclib 600mg and everolimus 5mg Level 3: ribociclib 600mg and everolimus 10mg

Eligible Conditions

Glioblastoma
Brain Tumor

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~2420

Everolimus

2010

Completed Phase 4

~1510