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NCT01059318 · ClinicalTrials.gov registry record · Phase 2
A Study to Determine the Safety and Effectiveness of RAD001 (Everolimus) in Patients With Lymphangioleiomyomatosis
A Phase 2 study of Lymphangioleiomyomatosis, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 4
- Study locations
NCT01059318: Completed Phase 2 study of Lymphangioleiomyomatosis, sponsored by Novartis Pharmaceuticals.
NCT01059318 is a Phase 2 study of Lymphangioleiomyomatosis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 24 participants, below the 828-participant average among 10 other Lymphangioleiomyomatosis trials with a reported enrollment target (97% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01059318, a Phase 2 study of Lymphangioleiomyomatosis, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 4
- Study locations
Study Summary
This was an exploratory study to determine whether escalating doses of RAD001 (everolimus) were safe and effective in patients with Lymphangioleiomyomatosis
Primary Outcome
Blood samples (1 mL) for determination of VEGF-D were collected from a forearm vein (direct venipuncture or from an indwelling cannula) and 2 aliquots of serum were collected. VEGF-D levels were determined from only 1 of the 2 serum aliquots, with the second acting as a back-up. A serum VEGF-D \>800 pg/mL level supports a diagnosis of Lymphangioleiomyomatosis (LAM)
Conditions Studied
Interventions
- DRUG Everolimus
Study Locations (4)
Other
- Novartis Investigative Site - Lyon
- Novartis Investigative Site - Milan
Massachusetts
- Center for LAM Research and Clinical Care - Boston
Ohio
- University of Cincinnati, Department of Internal Medicine, Pulmonary, Critical Care & Sleep Medicine, - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2010-01 |
| Est. Completion | 2012-06 |
| Phase | Phase 2 |
What the finished NCT01059318 record still lists
NCT01059318 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 828-participant average among 10 other Lymphangioleiomyomatosis trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Lymphangioleiomyomatosis appearing as the primary indexed condition, and to 1 intervention - of which Everolimus is the first listed.
NCT01059318 reports a single indexed study location in Other, Massachusetts, Ohio.
Frequently Asked Questions
What is clinical trial NCT01059318 about?
NCT01059318 is a clinical study titled "A Study to Determine the Safety and Effectiveness of RAD001 (Everolimus) in Patients With Lymphangioleiomyomatosis". This was an exploratory study to determine whether escalating doses of RAD001 (everolimus) were safe and effective in patients with Lymphangioleiomyomatosis
What is the current status of trial NCT01059318?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2010-01. Estimated completion is 2012-06.
What conditions does trial NCT01059318 study?
This clinical trial studies the following conditions: Lymphangioleiomyomatosis.
What interventions are being tested in trial NCT01059318?
The interventions under investigation include: Everolimus (DRUG).
Who is sponsoring clinical trial NCT01059318?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01059318 being conducted?
This trial has 4 study locations across Massachusetts, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Lymphangioleiomyomatosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01059318's enrollment target sits among peer trials
24 9th of 10 higher than 2 of 10 other Lymphangioleiomyomatosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphangioleiomyomatosis 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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