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NCT01880749 · ClinicalTrials.gov registry record · Early Phase 1
Exploring the Activity of RAD001 in Vestibular Schwannomas and Meningiomas
A Early Phase 1 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 5
- Enrollment target
NCT01880749: Completed Early Phase 1 study, sponsored by NYU Langone Health.
NCT01880749 is a Early Phase 1 study that has completed, run by NYU Langone Health. The registered enrollment target is 5 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01880749, a Early Phase 1 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
The primary objective is to estimate the proportions of vestibular schwannomas (VS) and meningiomas after 10 days of exposure to the study drug RAD001 at a dose of 10 mg daily, as determined by immunohistochemistry. This is a "phase 0" PK (pharmacokinetic) and PD (pharmacodynamic) study of RAD001 in patients with Neurofibromatosis Type 2-related and sporadic VS and meningiomas. Enrolled patients will take RAD001 prior to a scheduled VS or meningioma surgery, and blood and tissue samples will be obtained for further analysis.
Primary Outcome
1\) To estimate the proportions of VS and meningiomas with complete inhibition of phospho-S6 after10 days of exposure to RAD001 at a dose of 10 mg daily, as determined by immunohistochemistry. This endpoint was chosen based on prior pharmacodynamic data from a published trial, showing complete inhibition of phospho-S6 in solid tumor tissue of patients treated with RAD001 and our own preliminary data confirming baseline phospho-S6 expression in VS and meningiomas.
Interventions
- DRUG RAD001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2013-06 |
| Est. Completion | 2019-12 |
| Phase | Early Phase 1 |
What the finished NCT01880749 record still lists
NCT01880749 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which RAD001 is the first listed.
NCT01880749 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01880749 about?
NCT01880749 is a clinical study titled "Exploring the Activity of RAD001 in Vestibular Schwannomas and Meningiomas". The primary objective is to estimate the proportions of vestibular schwannomas (VS) and meningiomas after 10 days of exposure to the study drug RAD001 at a dose of 10 mg daily, as determined by immunohistochemistry. This is a "phase 0" PK (pharmacokinetic) and PD (pharmacodynamic) study of RAD001 in...
What is the current status of trial NCT01880749?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2013-06. Estimated completion is 2019-12.
What interventions are being tested in trial NCT01880749?
The interventions under investigation include: RAD001 (DRUG).
Who is sponsoring clinical trial NCT01880749?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01880749's enrollment target sits among peer trials
5 1888th of 2000 higher than 80 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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