Effectiveness and safety of RAD001 in patients of all ages with Subependymal Giant Cell Astrocytoma associated with Tuberous Sclerosis Complex (TSC)

• Conditions: This study will evaluate the antitumor activity of RAD001 versus placebo in patients with subependymal giant cell astrocytomas (SEGA) associated with Tuberous Sclerosis Complex (TSC).; MedDRA version: 17.1Level: PTClassification code 10045138Term: Tuberous sclerosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2007-006997-27-NL
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-03
• Last Update Posted: 8 December 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 99

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
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified