Ignite Creation Date:
2024-05-06 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03509636
Status:
COMPLETED
Last Update Posted:
2022-07-01
First Post:
2018-02-25
Brief Title:
A Study of FluzoparibSHR-3162in BRCA12-mutant Relapsed Ovarian Cancer
Sponsor:
Jiangsu HengRui Medicine Co Ltd
Organization:
Jiangsu HengRui Medicine Co Ltd
Study Overview
Official Title:
An Open-Label Study to Assess the Efficacy And Safety of PolyADP-ribose Polymerase Inhibitor FluzoparibSHR3162in Patients With Relapsed High-grade Epithelial Ovarian Fallopian Tube or Primary Peritoneal Cancer and BRCA12 Mutation
Status:
COMPLETED
Status Verified Date:
2022-06
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 multicenter open-label study to evluate the efficacy and safety of a novel PARP 12 inhibitor fluzoparib SHR-3162in BRCA12-mutant Relapsed Ovarian Cancer
Detailed Description:
Fluzoparib SHR-3162 is an orally available small molecule inhibitor of poly-adenosine diphosphate ADP ribose polymerase PARP 12 being developed for treatment of BRCA12-mutant solid tumor The tolerability safety and PK of fluzoparib has been evaluated in Phase 1 study An oral formulation is the focus of current development efforts
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