Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1)
