Overview
Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1)
Status:
Completed
Completed
Trial end date:
2014-10-01
2014-10-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study evaluated the efficacy and safety of Everolimus in treating patients with Subependymal Giant Cell Astrocytomas associated with Tuberous Sclerosis Complex.Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Novartis PharmaceuticalsTreatments:
Everolimus
Sirolimus
Criteria
Inclusion Criteria:- 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
Exclusion Criteria:
- 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