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

NCT03834740 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-05-30

Study results available
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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

Conditions

Interventions

DRUG

Ribociclib

Ribociclib administered orally in 5 daily doses prior to resection

DRUG

Everolimus

Everolimus administered orally in 5 daily doses prior to resection

Sponsors & Collaborators

  • Ivy Brain Tumor Center

    collaborator OTHER

  • Barrow Neurological Institute

    collaborator OTHER

  • St. Joseph's Hospital and Medical Center, Phoenix

    lead OTHER

Principal Investigators

  • Nader Sanai, MD · Deputy Director of the Ivy Brain Tumor Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-19
Primary Completion
2022-02-18
Completion
2022-02-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03834740 on ClinicalTrials.gov