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NCT03834740 · ClinicalTrials.gov registry record · Early Phase 1
A Phase 0/I Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection
A Early Phase 1 study, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 27
- Enrollment target
NCT03834740: Completed Early Phase 1 study, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
NCT03834740 is a Early Phase 1 study that has completed, run by St. Joseph's Hospital and Medical Center, Phoenix. The registered enrollment target is 27 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03834740, a Early Phase 1 study, has completed, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 27 participants
- Enrollment target
Study 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
Primary Outcome
Highest dose of each drug that did not cause a DLT in \>17% of participants
Interventions
- DRUG Everolimus
- DRUG Ribociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2019-01-19 |
| Est. Completion | 2022-02-18 |
| Phase | Early Phase 1 |
What the finished NCT03834740 record still lists
NCT03834740 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 2 interventions - of which Everolimus is the first listed.
NCT03834740 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03834740 about?
NCT03834740 is a clinical study titled "A Phase 0/I Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection". 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 (l...
What is the current status of trial NCT03834740?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 27 participants. The study started on 2019-01-19. Estimated completion is 2022-02-18.
What interventions are being tested in trial NCT03834740?
The interventions under investigation include: Everolimus (DRUG), Ribociclib (DRUG).
Who is sponsoring clinical trial NCT03834740?
This trial is sponsored by St. Joseph's Hospital and Medical Center, Phoenix, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03834740's enrollment target sits among peer trials
27 963rd of 2000 higher than 1,025 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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