Ignite Creation Date:
2024-05-06 @ 12:15 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01529450
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2011-10-11
Brief Title:
Pilot LDE225 in Locally Advanced or Metastatic BCC Previously Tx Non-LDE225 Smoothened Inhibitors
Sponsor:
Anne Chang
Organization:
Stanford University
Study Overview
Official Title:
A Pilot Open-Label Study to Examine the Safety and Efficacy of Oral LDE225 in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma Who Have Been Previously Treated With Non-LDE225 Smoothened Inhibitors
Status:
COMPLETED
Status Verified Date:
2016-11
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 is a prospective single-center open label pilot study to investigate the safety and efficacy of LDE225 in patients with locally advanced or metastatic basal cell carcinoma
Primary Objectives
To explore the effects of oral LDE225 on the Progression Free Survival PFS of individuals with locally advanced or metastatic BCC who have been previously treated with a non-LDE225 Smo inhibitor
Secondary Objectives
To evaluate the effect of oral LDE225 on tumor tissue biomarkers of BCC activation Gii 1 2 Patched 12 and Ki67 in individuals which are non-naive to Smo inhibitors other than LDE225 at baseline and at end-of-treatment
To describe adverse effects of oral LDE225 in individuals with a history of non-LDE225 Smo inhibitor usage
To assess the overall survival rates of individuals with locally advanced BCC or metastatic BCC who have previously taken a non-LDE225 Smo inhibitor after treatment with LDE225
Primary Objectives
To explore the effects of oral LDE225 on the Progression Free Survival PFS of individuals with locally advanced or metastatic BCC who have been previously treated with a non-LDE225 Smo inhibitor
Secondary Objectives
To evaluate the effect of oral LDE225 on tumor tissue biomarkers of BCC activation Gii 1 2 Patched 12 and Ki67 in individuals which are non-naive to Smo inhibitors other than LDE225 at baseline and at end-of-treatment
To describe adverse effects of oral LDE225 in individuals with a history of non-LDE225 Smo inhibitor usage
To assess the overall survival rates of individuals with locally advanced BCC or metastatic BCC who have previously taken a non-LDE225 Smo inhibitor after treatment with LDE225
Detailed Description:
This is a prospective single-center open label pilot study to investigate the safety and efficacy of LDE225 in patients with locally advanced or metastatic basal cell carcinoma
Primary Objectives
To explore the effects of oral LDE225 on the Progression Free Survival PFS of individuals with locally advanced or metastatic BCC who have been previously treated with a non-LDE225 Smo inhibitor
Secondary Objectives
To evaluate the effect of oral LDE225 on tumor tissue biomarkers of BCC activation eg Gli and Ki67 in individuals which are non-naive to Smo inhibitors other than LDE225 at baseline and at end-of-treatment
To describe adverse effects of oral LDE225 in individuals with a history of non-LDE225 Smo inhibitor usage
Primary Objectives
To explore the effects of oral LDE225 on the Progression Free Survival PFS of individuals with locally advanced or metastatic BCC who have been previously treated with a non-LDE225 Smo inhibitor
Secondary Objectives
To evaluate the effect of oral LDE225 on tumor tissue biomarkers of BCC activation eg Gli and Ki67 in individuals which are non-naive to Smo inhibitors other than LDE225 at baseline and at end-of-treatment
To describe adverse effects of oral LDE225 in individuals with a history of non-LDE225 Smo inhibitor usage
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 |
|---|---|---|---|
| 21759 | OTHER | Stanford IRB | None |
| SU-09022011-8371 | OTHER | None | None |