Ignite Creation Date:
2024-05-06 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04716686
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2020-12-09
Brief Title:
Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma
Sponsor:
Shandong University
Organization:
Shandong University
Study Overview
Official Title:
Niraparib Monotherapy as Maintain and Recurrent Treatment of Endometrial Serous Carcinoma A Multi-center Open-label Prospective Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-01
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:
Endometrial Serous carcinoma ESC has similar molecular characteristics to high-grade serous ovarian carcinoma HGSOC and basal cell-like breast cancer such as similar Chromosomal instability somatic copy number variation profiles and somatic mutations The clinical treatment of ESC also refers to the treatment model of HGSOC The PARP inhibitor niraparib used in this study which was approved by FDA for the maintenance treatment of adult patients with recurrent epithelial ovarian fallopian tube or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy on March 27 2017
The homologous recombination related gene mutations in total endometrial cancer accounted for 22 Homologous Recombination Repair Defect HRD ARID1A accounted for 48 and 53 of endometrial cancer cell lines were sensitive to PARP inhibitors The incidence of HRD in endometrial cancer with high copy number the pathological type is mainly ESC is 50 suggesting potential clinical applications of PARP inhibitors for the treatment of ESC
The homologous recombination related gene mutations in total endometrial cancer accounted for 22 Homologous Recombination Repair Defect HRD ARID1A accounted for 48 and 53 of endometrial cancer cell lines were sensitive to PARP inhibitors The incidence of HRD in endometrial cancer with high copy number the pathological type is mainly ESC is 50 suggesting potential clinical applications of PARP inhibitors for the treatment of ESC
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