Ignite Creation Date:
2024-05-06 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 2:17 PM
Study NCT ID:
NCT05108740
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2021-12-09
First Post:
2021-09-09
Brief Title:
MAP Treatment Plan With Afinitor for Postmenopausal Women With Advanced HR Breast Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Managed Access Program MAP Cohort Treatment Plan CRAD001Y2002M to Provide Access to Afinitor for Patients With Advanced Hormone Receptor Positive HR Breast Cancer
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2021-11
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:
The purpose of this Managed Access Program MAP Cohort Treatment Plan is to provide guidance to the Physician for the treatment and monitoring of patients in the Cohort MAP
Detailed Description:
Prior to inclusion of a patient in the Cohort the requesting Physician must submit a request for access to the product in GEMS Grants External Requests and Managed Access System accessible through httpswwwnovartiscomour-focushealthcare-professionalsmanagedaccess-programs providing the rationale for the request and relevant medical history of the patient
The request is then assessed against the MAP and Cohort inclusionexclusion criteria by the medical team experienced with the product and indication Upon the required approvals the patient is included in the Cohort
The request is then assessed against the MAP and Cohort inclusionexclusion criteria by the medical team experienced with the product and indication Upon the required approvals the patient is included in the Cohort
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