Trials / Completed
CompletedNCT01880749
Exploring the Activity of RAD001 in Vestibular Schwannomas and Meningiomas
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- NYU Langone Health · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RAD001 |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2019-12-01
- Completion
- 2019-12-01
- First posted
- 2013-06-19
- Last updated
- 2020-05-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01880749. Inclusion in this directory is not an endorsement.