Ignite Creation Date:
2024-05-06 @ 2:56 PM
Last Modification Date:
2024-10-26 @ 1:40 PM
Study NCT ID:
NCT04473040
Status:
AVAILABLE
Last Update Posted:
2023-10-25
First Post:
2020-07-10
Brief Title:
Managed Access Program to Provide Access to Alpelisib for Patients With Advanced Breast Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Managed Access Program MAP Cohort Treatment Plan CBYL719C2001M to Provide Access to Alpelisib BYL719 for Patients With HR-positive HER2-negative Advanced Breast Cancer With Mutated Phosphoinositide 3-kinase Who Progressed on or After AI Treatment
Status:
AVAILABLE
Status Verified Date:
2024-07
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 Cohort Treatment Plan is to allow access to alpelisib for patients diagnosed with HR-positive HER2-negative advanced breast cancer with mutated phosphoinositide 3-kinase who progressed on or after AI treatment The patients Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations
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