drugset
drugset / Trial / NCT03834740

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

NCT03834740 ↗

Phase 0 Completed 27 enrolled St. Joseph's Hospital and Medical Center, Phoenix Barrow Neurological Institute · collabIvy Brain Tumor Center · collab
Non-randomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2019-01-19
Primary completion
2022-02-18
Completion
2022-02-18

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Everolimus Small molecule 2.5 mg Oral
Subject Everolimus Small molecule 5 mg Oral
Subject Everolimus Small molecule 10 mg Oral
Subject Ribociclib Small molecule 400 mg Oral
Subject Ribociclib Small molecule 600 mg Oral

Indications

brain glioma glioblastoma