Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-01-07 @ 1:32 PM
Study NCT ID:
NCT03285802
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2017-09-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Plan for an Individual Patient With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation
Sponsor:
Greater Baltimore Medical Center
Organization:
Study Overview
Official Title:
CRAD001X2401: Treatment Plan for an Individual Patient With Recurrent Uterine Papillary Serous Carcinoma (UPSC) With PIK3CA Gene Mutation
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label treatment program following basic prescribing information for patients with recurrent UPSC (Uterine Papillary Serous Carcinoma) to provide access to everolimus and limited treatment alternatives.
Detailed Description:
The objective is to provide access to everolimus for patients with Recurrent UPSC and limited treatment alternatives.
Letrozole 2.5mg daily q 30 days Everolimus 10mg daily q 28 days
Letrozole 2.5mg daily q 30 days Everolimus 10mg daily q 28 days
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
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?: