Trial intelligence / Profile preview

Everolimus for Angiomyolipoma in TSC or LAM (EXIST-2)

NCT00790400Phase 3

Key facts

Status: Completed
Start: Apr 2009
Primary completion: Jun 2011
Countries: 11
Sponsor: Novartis

Drugs: everolimus
Conditions: renal angiomyolipoma (AML)

Overview

Phase 3, randomised, double-blind trial in renal angiomyolipoma (AML) comparing Everolimus Arm with Placebo Arm (2 arms). Primary endpoint: Angiomyolipoma Response Rate up to 5.7 years. Started Apr 2009; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Everolimus Arm
Everolimus 10 mg (two 5 mg tablets) daily
Placebo Arm
Matching placebo (two 5 mg tablets) daily

Who it enrols

Adults with a definite diagnosis of TSC or sporadic LAM and at least one renal angiomyolipoma ≥ 3 cm in diameter.

Endpoints

Primary

Angiomyolipoma Response Rateup to 5.7 years

Secondary

Time to Angiomyolipoma Progressionup to 5.7 years
Skin Lesion Response Rateup to 5.7 years
Percentage of Participants With Renal Impairmentup to 28 days after end of treatment
Change From Baseline in Plasma Angiogenic Molecules - Vascular Endothelial Growth Factor72 weeks
Everolimus Trough Concentrations48 weeks
Everolimus Blood Concentrations at 2 Hours Post-dose48 weeks
Time to Angiomyolipoma Responseup to 5.7 years
Duration of Angiomyolipoma Responseup to 5.7 years

Results

Primary endpoints met

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