A randomized, double-blind, placebo-controlled study of RAD001 in the treatment of patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC)
Phase 3
Completed
- Conditions
- subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC)10027656
- Registration Number
- NL-OMON37063
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 7
Inclusion Criteria
1. All Ages;2. Definite diagnosis of Tuberous Sclerosis;3. At least one Subependymal Giant Cell Astrocytoma of at least 1 cm in diameter ;4. Evidence of SEGA progression as compared to prior MRI scans ;5. Females of child bearing potential must use birth control
Exclusion Criteria
1. Recent heart attack, cardiac related chest pain or stroke ;2. Severely impaired lung function ;3. Severe liver dysfunction;4. Severe kindney dysfuntion ;5. Pregnancy or breast feeding ;6. Current infection ;7. History of organ transplant;8. Surgery within two month prior to study enrollement ;9. Uncontrolled diabetes ;10.HIV ;11.Patients with metal implants thus prohibiting MRI evaluations
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Objective:<br /><br>To compare the SEGA response rate in patients with TSC-associated SEGA on<br /><br>RAD001 versus placebo.</p><br>
- Secondary Outcome Measures
Name Time Method