Ignite Creation Date:
2024-05-06 @ 12:12 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03706573
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2021-07-19
First Post:
2018-10-10
Brief Title:
Managed Access Program to Provide Alpelisib for Patients With HR Advanced or Metastatic Breast Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Managed Access Program MAP to Provide Alpelisib for Patients With HR Advanced or Metastatic Breast Cancer Resistant or Refractory to Available Treatment Options
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2021-07
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 eligible patients diagnosed with hormone receptor positive advanced or metastatic breast cancer harboring a phosphatidylinositol 3-kinase PI3KCA mutation 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