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

Part of paid clinical trials in Chandler, Arizona.

Sponsor
St. Joseph's Hospital and Medical Center, Phoenix
Study ID
NCT03834740
Phase
EARLY_PHASE1
Status
Completed

Conditions

  • Glioblastoma Multiforme
  • Glioma of Brain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib — DRUG
    Ribociclib administered orally in 5 daily doses prior to resection
  • Everolimus — DRUG
    Everolimus administered orally in 5 daily doses prior to resection

Study Details

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

Key Dates

Start date
Jan 19, 2019
Status verified
May 2025
Primary completion
Feb 18, 2022
Completion
Feb 18, 2022

Study Design

Enrollment
27 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: last dose 1 to 3 hours prior to resection
    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
  • Experimental: Cohort 2: last dose 7 to 9 hours prior to resection
    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
  • Experimental: Cohort 3: last dose 23 to 25 hours prior to resection
    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

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: From the date of the first dose given until the second documented DLT, assessed up to 24 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Chandler Regional Medical CenterChandlerArizona85224-
St. Joseph's Hospital and Medical CenterPhoenixArizona85013-
HonorHealth Scottsdale Osborn Medical CenterScottsdaleArizona85251-

Find similar trials in Chandler, AZ

By research site
Chandler Regional Medical Center· Chandler, AZSt. Joseph's Hospital and Medical Center· Phoenix, AZHonorHealth Scottsdale Osborn Medical Center· Scottsdale, AZ

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