Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539091
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-31
Brief Title:
Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-Arm Open Multicenter Exploratory Clinical Study of Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer FAT-1
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a single-arm open multicenter exploratory clinical study to observe and evaluate the efficacy and safety of fluazoparib combined with apatinib mesylate in the treatment of patients with ovarian cancer
Patients with epithelial ovarian fallopian tube and primary peritoneal cancers will be selected as the study population with Progression-Free Survival PFS as the primary study endpoint and Overall Survival OS Duration Of Response DOR Quality of Life Score QoL Chemotherapy-Free Interval CFI Progression-Free Survival 2 PFS-2 CA125 response criteria by GCGI to access the safetyBone Mineral Density BMD changes and the tolerability of fluazoparib in combination with apatinib mesylate
The study is planned to enroll 51 subjects all of whom will receive study treatment after being signed informed and screened
Patients with epithelial ovarian fallopian tube and primary peritoneal cancers will be selected as the study population with Progression-Free Survival PFS as the primary study endpoint and Overall Survival OS Duration Of Response DOR Quality of Life Score QoL Chemotherapy-Free Interval CFI Progression-Free Survival 2 PFS-2 CA125 response criteria by GCGI to access the safetyBone Mineral Density BMD changes and the tolerability of fluazoparib in combination with apatinib mesylate
The study is planned to enroll 51 subjects all of whom will receive study treatment after being signed informed and screened
Detailed Description:
During the treatment period subjects were given fluazoparib capsules orally two capsulesdose 50mgcapsule twice daily taken orally in the morning and in the evening as a continuous dosage Subjects will also receive oral apatinib mesylate tablets one tabletdose 250 mgtablet once daily continuously Treatment will continue until an event occurs that meets the criteria for discontinuation of treatment
Safety evaluations will be performed on Day 1 of each 3-week treatment cycle vital signs physical examination laboratory examination physical status score and BMD testing imaging evaluations and once CA125 test will be performed every 6 weeks for the first 24 weeks of dosing and every 9 weeks thereafter to assess efficacy and for 12 months or until an event occurs that meets the criteria for treatment discontinuation Dose suspension or downward adjustment may be made during the study period based on the occurrence of adverse events in subjects
Safety evaluations will be performed on Day 1 of each 3-week treatment cycle vital signs physical examination laboratory examination physical status score and BMD testing imaging evaluations and once CA125 test will be performed every 6 weeks for the first 24 weeks of dosing and every 9 weeks thereafter to assess efficacy and for 12 months or until an event occurs that meets the criteria for treatment discontinuation Dose suspension or downward adjustment may be made during the study period based on the occurrence of adverse events in subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None