Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1)

Completed · Phase 3 · Has a placebo group

Conditions studied: Tuberous Sclerosis, Subependymal Giant Cell Astrocytoma

In brief

This study evaluated the efficacy and safety of Everolimus in treating patients with Subependymal Giant Cell Astrocytomas associated with Tuberous Sclerosis Complex.

Key facts

Study ID

NCT00789828

Run by

Novartis Pharmaceuticals

People needed

117

Starts

2009-08-01

Expected to finish

2014-10-01

Last updated by the study team

2016-02-03

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All Ages
• Definite diagnosis of Tuberous Sclerosis according to the modified Gomez criteria
• At least one Subependymal Giant Cell Astrocytoma of at least 1 cm in diameter
• Evidence of SEGA worsening as compared to prior MRI scans
• Females of child bearing potential must use birth control
• Written informed consent

You may not qualify if…

• SEGA related surgery is likely to be required in the opinion of the investigator
• Recent heart attack, cardiac related chest pain or stroke
• Severely impaired lung function
• Severe liver dysfunction
• Severe kidney dysfunction
• Pregnancy or breast feeding
• Current infection
• History of organ transplant
• Surgery within two months prior to study enrollment
• Prior therapy with a medication in the same class as Everolimus
• Uncontrolled high cholesterol
• Uncontrolled diabetes
• HIV
• Patients with metal implants thus prohibiting MRI evaluations
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Barrow Tuberous Sclerosis Center — Phoenix, Arizona, United States
• University of California at Los Angeles — Los Angeles, California, United States
• Children's Hospital Oakland Hematology/Oncology Dept — Oakland, California, United States
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States
• University of CHicago Comer Children's Hospital — Chicago, Illinois, United States
• Massachusetts General Hospital Mass General — Boston, Massachusetts, United States
• Children's Hospital Boston SC-1 — Boston, Massachusetts, United States
• Minnesota Epilepsy Group - PA — Saint Paul, Minnesota, United States
• Cincinnati Children's Hospital Medical Center Cincinnati Children's Hosp — Cincinnati, Ohio, United States
• Texas Scottish Rite Hospital for Children — Dallas, Texas, United States
• Children's Regional Outpatients Center SC — Fairfax, Virginia, United States
• Novartis Investigative Site — Randwick, New South Wales, Australia
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Québec, Canada
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Heidelberg, Germany
• Novartis Investigative Site — Genova, GE, Italy
• Novartis Investigative Site — Roma, Italy
• Novartis Investigative Site — Utrecht, Netherlands, Netherlands
• Novartis Investigative Site — Warsaw, Poland
• Novartis Investigative Site — Moscow, Russia
• Novartis Investigative Site — Bristol, United Kingdom

Full record on ClinicalTrials.gov

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