Ignite Creation Date:
2024-05-06 @ 6:02 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05523440
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2022-08-29
Brief Title:
Bevacizumab andor Niraparib in Patients With Recurrent Endometrial andor Ovarian Cancer With ARID1A Mutation
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
Phase 2 Trial of Niraparib or Niraparib and Bevacizumab Combination in Patients With Recurrent Endometrial Cancer andor Ovarian Cancer With ARID1A Mutation OU-SCC-ARID1A
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:
The purpose of this research study is to test the proportion of tumor response to the combination treatment with niraparib and bevacizumab and see what effects good and bad this combination treatment has on patients with recurrent endometrial or ovarian cancer with ARID1A mutation
Detailed Description:
Patients will have tests and exams to see if they are eligible for the clinical trial If found eligible the patient will be randomized into one of two groups and receive treatment as follows If patients are in the first groupthey will receive niraparib alone once daily taken by mouth If patients are in the second group they will receive niraparib once daily taken by mouth and infusion of bevacizumab once every 3 weeks
Patients will receive the study treatment as long as there is evidence that the tumor is not growing or spreading and they are not having any unacceptable bad side effects
Patients will be monitored during treatment with tests and exams and after treatment completion for up to 3 years
Patients will receive the study treatment as long as there is evidence that the tumor is not growing or spreading and they are not having any unacceptable bad side effects
Patients will be monitored during treatment with tests and exams and after treatment completion for up to 3 years
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?:
None
Is an FDA AA801 Violation?:
None