Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06243185
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2024-01-09
Brief Title:
Dalpiciclib Combined With Letrozole in HRHER2 - Gynecologic Solid Tumors
Sponsor:
Fengzhi Feng
Organization:
Peking Union Medical College Hospital
Study Overview
Official Title:
A Phase II Study of the CDK46 Inhibitor Dalpiciclib Combined With Letrozole in Unresectable Refractory or Resistant Recurrent HRHER2 - Gynecologic Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-02
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:
This is a prospective single-arm single-center registry study to investigate 6-month progression-free survival with Dalpiciclib a CDK46 kinase inhibitor plus letrozole in patients with unresectable refractory or resistant recurrent HR-positive HER2-negative gynecologic solid tumors Dalpiciclib is a CDK46 kinase inhibitor that selectively inhibits the activity of CDK46 kinase so that the complex with Cyclin D cannot phosphorylate the downstream Rb protein and prevent cells from entering the S phase from G1 phase thereby inhibiting cell proliferation and anti-tumor effects
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?:
None