Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04872608
Status:
WITHDRAWN
Last Update Posted:
2023-04-28
First Post:
2021-04-29
Brief Title:
A Study of Letrozole Palbociclib and Onapristone ER in People With Metastatic Breast Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
ctDNA-guided Adaptive Therapy Escalation in ER MBC A Phase 1b Study With Letrozole Palbociclib and Onapristone ER
Status:
WITHDRAWN
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The sponsor closed the study due to discontinuing their onapristone program
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The researchers are doing this study to find out whether the study drug onapristone ER combined with the standard treatment for your cancer letrozole and palbociclib is a safe treatment for people who have metastatic or unresectable ERPRHER2- breast cancer The researchers will test different doses of the study drug to find the highest dose that causes few or mild side effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None