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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 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.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03834740
The ClinicalTrials.gov registry entry for NCT03834740 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Joseph's Hospital and Medical Center, Phoenix, which has 44 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Everolimus is the first listed.
NCT03834740 reports 0 study locations.
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.
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