Status:
COMPLETED
Efficacy and Safety of Everolimus (RAD001) in Patients of All Ages With Subependymal Giant Cell Astrocytoma Associated With Tuberous Sclerosis Complex (TSC)(EXIST-1)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Tuberous Sclerosis
Subependymal Giant Cell Astrocytoma
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
This study evaluated the efficacy and safety of Everolimus in treating patients with Subependymal Giant Cell Astrocytomas associated with Tuberous Sclerosis Complex.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00789828
Start Date
August 1 2009
End Date
October 1 2014
Last Update
February 3 2016
Active Locations (24)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Barrow Tuberous Sclerosis Center
Phoenix, Arizona, United States, 85013
3
University of California at Los Angeles
Los Angeles, California, United States, 90048
4
Children's Hospital Oakland Hematology/Oncology Dept
Oakland, California, United States, 94609-1809