CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
Everolimusdrug
Likely dose
Everolimus 2.5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01059318
NCT01059318Phase 2Completed
CompareCT.gov

An Exploratory, Open-label, Non-randomized, Within-patient Multiple Dose-escalation Safety, Tolerability, PK and Efficacy Trial of RAD001 (Everolimus) in Patients With Lymphangioleiomyomatosis

Novartis Pharmaceuticals·interventional·Posted Jan 29, 2010·Updated Nov 19, 2020

In Brief

A Phase 2 clinical trial evaluating Everolimus for Lymphangioleiomyomatosis. Completed, enrolled 24 participants across 4 sites in 3 countries.

Detailed Summary

This was an exploratory study to determine whether escalating doses of RAD001 (everolimus) were safe and effective in patients with Lymphangioleiomyomatosis

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphangioleiomyomatosis
CountriesFrance, Italy, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 29, 2010
Enrollment StartJan 1, 2010
Primary CompletionJun 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 16.4 years ago

Interventions

Everolimusdrug

Everolimus was formulated as tablets in strengths of 2.5mg, 5mg and 10mg.