Ignite Creation Date:
2024-05-05 @ 10:32 PM
Last Modification Date:
2024-10-26 @ 10:20 AM
Study NCT ID:
NCT01125800
Status:
COMPLETED
Last Update Posted:
2017-03-20
First Post:
2010-05-12
Brief Title:
A Phase I Dose Finding and Safety Study of Oral LDE225 in Children and a Phase II Portion to Assess Preliminary Efficacy in Recurrent or Refractory MB
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase III Study of LDE225 in Pediatric Patients With Recurrent or Refractory Medulloblastoma or Other Tumors Potentially Dependent on the Hedgehog-signaling Pathway and Adult Patients With Recurrent or Refractory Medulloblastoma
Status:
COMPLETED
Status Verified Date:
2016-02
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:
Phase I dose-escalation study to characterize the safety tolerability pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in children with recurrent or refractory medulloblastoma or other tumors potentially dependent on Hedgehog signaling pathway
Phase II study is to assess preliminary efficacy in both adult and pediatric patients with recurrent or refractory MB
Phase II study is to assess preliminary efficacy in both adult and pediatric patients with recurrent or refractory MB
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2010-019348-37 | EUDRACT_NUMBER | None | None |