Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00515086
Status:
TERMINATED
Last Update Posted:
2011-09-22
First Post:
2007-08-10
Brief Title:
Study of Everolimus RAD001 in Patients With Recurrent Glioblastoma Multiforme GBM
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase II Trial of RAD001 in Patients With Recurrent Glioblastoma Multiforme
Status:
TERMINATED
Status Verified Date:
2011-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Early termination due to slow enrollment and protocol-defined stopping rule
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will define the safety and efficacy of Everolimus RAD001 administered daily in patients with glioblastoma multiforme GBM
Detailed Description:
This was a multicenter open label randomized study of RAD001 dosed daily in patients with recurrent GBM The study was conducted with 2 parallel groups of patients Group 1 was designed to study the biological effects of RAD001 in patients scheduled to undergo salvage surgical resection and Group 2 was to enroll patients who were not scheduled for surgery Patients in Group 1 were randomly assigned to one of three pre-surgery treatment groups 0 5 or 10 mgday RAD001 for 7 days All patients in Group 2 were to receive a fixed daily dose of 10 mgday oral RAD001
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None