Ignite Creation Date:
2024-05-05 @ 11:33 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01350115
Status:
COMPLETED
Last Update Posted:
2015-10-19
First Post:
2011-05-06
Brief Title:
Efficacy Safety and Pharmacokinetics of Oral LDE225 in Treatment of Patients With Nevoid Basal Cell Carcinoma Syndrome NBCCS
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase II Double-blind Randomized Proof-of-Concept Dose-ranging Trial Evaluating the Efficacy Safety and Pharmacokinetics of Oral LDE225 in Treatment of Adult Patients With Nevoid Basal Cell Carcinoma Syndrome
Status:
COMPLETED
Status Verified Date:
2015-09
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 was a phase II double-blind randomized proof-of-concept dose-ranging trial evaluating the efficacy safety and pharmacokinetics of oral LDE225 in treatment of adult patients with NBCCS This was an exploratory study designed to demonstrate preliminary efficacy of LDE225 in this indication This study included a Screening period of approximately 4 weeks treatment period duration of 12 weeks with initial follow-up of approximately 6-8 weeks followed by a long-term follow-up period
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 |
|---|---|---|---|
| 2010-023819-34 | EUDRACT_NUMBER | None | None |