Ignite Creation Date:
2024-05-06 @ 12:59 AM
Last Modification Date:
2024-10-26 @ 10:57 AM
Study NCT ID:
NCT01708174
Status:
COMPLETED
Last Update Posted:
2017-08-11
First Post:
2012-10-11
Brief Title:
A Phase II Study of Oral LDE225 in Patients With Hedge-Hog Hh-Pathway Activated Relapsed Medulloblastoma MB
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase II Multi-center Open-label Single-arm Study of the Efficacy and Safety of Oral LDE225 in Patients With Hh-pathway Activated Relapsed Medulloblastoma
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This Phase II study evaluated the safety and efficacy of LDE225 in adult and pediatric patients with Hh-pathway activated relapsed MB
Detailed Description:
This study was a single-arm study of the efficacy and safety of oral sonidegib in patients with Hh-pathway activated relapsed medulloblastoma It was initially designed as a randomized controlled open-label phase III study of adults and children with Hh-pathway activated MB whose disease had failed standard of care therapy including radiation therapy RT The original study consisted of a randomized controlled part and a non-randomized uncontrolled part Approximately 69 patients were to be randomized in a 21 ratio to receive sonidegib oral suspension or the active control temozolomide TMZ capsules Randomization was to be stratified according to age 18 years versus 18 years Approximately 40 patients were to receive sonidegib in the non-randomized uncontrolled part of the study Following the enrollment of 11 patients the study was amended to become a phase II single-arm study with only sonidegib and the target enrollment was changed to 20 patients Prior to the study amendment TMZ participants whose disease progressed while on TMZ were permitted to crossover to sonidegib After the amendment participants receiving TMZ were crossed over to sonidegib
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