EUCTR2007-006997-27-DE
Active, not recruiting
Not Applicable
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) - N/A
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- This study will evaluate the antitumor activity of RAD001 versus placebo in patientswith subependymal giant cell astrocytomas (SEGA) associated with TuberousSclerosis Complex (TSC).
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 99
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female of any age.
- •2\. Clinically definite diagnosis of tuberous sclerosis according to the modified
- •Gomez criteria (Roach et al, 1998; Hyman and Whittemore, 2000, Table 5\-1\).
- •Clinically definite diagnosis is defined as either of the following:
- •a. Two Major Features from Table 5\-1\.
- •b. One Major Feature plus two Minor Features from Table 5\-1\.
- •3\. Presence of at least one SEGA lesion \= 1\.0 cm in its longest diameter using
- •Note: SEGA lesions are only diagnosed in patients with TSC. They arise in the
- •subependymal layer of the lateral ventricle and are always located near the
- •foramen of Monro and enhance homogeneously with contrast on MRI with no
Exclusion Criteria
- •1\. Patients for whom SEGA related surgery is likely to be required, in the opinion of
- •the investigator.
- •2\. Prior brain surgery.
- •3\. History of myocardial infarction, angina or stroke related to atherosclerosis
- •4\. Impaired lung function, defined as any of the following:
- •a. FEV1 \= 70% of predicted, or
- •b. DLCO \= 70% of predicted, or
- •c. \= 88% O2 saturation at rest in room air, or
- •d. for patients unable to perform pulmonary function testing:
- •i. clinical evidence of significantly impaired lung function, or
Outcomes
Primary Outcomes
Not specified
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