Ignite Creation Date:
2024-05-06 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03525834
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2018-05-03
Brief Title:
Safety and Efficacy of Everolimus Afinitor in Chinese Adult Patients With Angiomyolipoma Associated With Tuberous Sclerosis Complex
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Phase IV Single Arm Study of Safety and Efficacy of Everolimus in Chinese Adults With Tuberous Sclerosis Complex Who Have Renal Angiomyolipoma Not Requiring Immediate Surgery
Status:
COMPLETED
Status Verified Date:
2021-09
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:
The purpose of this study was to assess the safety and efficacy of everolimus Afinitor in Chinese patients with renal angiomyolipoma AML associated with tuberous sclerosis complex TSC
Detailed Description:
This was an open label single arm multi-center Phase IV Post-Approval Commitment PAC study with once daily oral dose of 10 mg everolimus in participants with renal AML associated with TSC There were three separate phases in this study a Screening phase an Open-label treatment phase where participants received everolimus for 48 weeks or until disease progression and a Treatment discontinuation follow-up phase for patients who discontinue study drug for reasons other than disease progression Every participant had an End of Treatment visit within 28 days after last dose and a safety follow-up visit 30 days after last dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None