Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06552858
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-11
Brief Title:
Fluzoparib Combined With Dalpiciclib for Platinum Resistant Recurrent Ovarian Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Fluzoparib Combined With Dalpiciclib for Platinum Resistant Recurrent Ovarian Cancer a Phase II Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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 aims to investigate the safety and efficacy of combination therapy of Fluzoparib combined With Dalpiciclib for platinum-resistant recurrent ovarian cancer through a single-center prospective single-arm phase II clinical trial to improve the overall treatment level and prognosis of platinum-resistant ovarian cancer
Detailed Description:
1 Overall Design This trial is a single-center prospective single-arm phase II clinical trial to evaluate the safety and efficacy of combination therapy of Fluzoparib combined With Dalpiciclib for platinum-resistant recurrent ovarian cancer
2 Experimental observation indicators 1 Main indicators progression-free survival PFS 2 Other indicators overall survival OS objective response rate ORR and adverse reactions
3 Sample size calculation The median PFS of platinum-resistant recurrent ovarian cancer patients is 38 months In comparison the experimental group is expected to have a median PFS of 7 months with an alpha value of 005 Following up for 1 year and considering a 10 dropout rate this study plans to include 30 platinum-resistant recurrent ovarian cancer patients
4 Data Processing Enter data and use SPSS statistical software for statistical analysis Statistical analyst Clinical Statistics Department of Fudan University Cancer Hospital Mailing address 270 Dongan Road Shanghai
2 Experimental observation indicators 1 Main indicators progression-free survival PFS 2 Other indicators overall survival OS objective response rate ORR and adverse reactions
3 Sample size calculation The median PFS of platinum-resistant recurrent ovarian cancer patients is 38 months In comparison the experimental group is expected to have a median PFS of 7 months with an alpha value of 005 Following up for 1 year and considering a 10 dropout rate this study plans to include 30 platinum-resistant recurrent ovarian cancer patients
4 Data Processing Enter data and use SPSS statistical software for statistical analysis Statistical analyst Clinical Statistics Department of Fudan University Cancer Hospital Mailing address 270 Dongan Road Shanghai
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