Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05965141
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-28
First Post:
2023-04-23
Brief Title:
Aribulin Combined With Carboplatin and Bevacizumab in the Treatment of Ovarian Cancer
Sponsor:
Second Affiliated Hospital of Guangzhou Medical University
Organization:
Second Affiliated Hospital of Guangzhou Medical University
Study Overview
Official Title:
A Phase II Prospective Single-arm Clinical Study of Aribulin Combined With Carboplatin and Bevacizumab in the First-line Treatment of Platinum-sensitive Recurrent Ovarian Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-04
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 prospective phase II single-center single-arm clinical study of platinum-sensitive relapsed ovarian cancer The main objective of this study is to evaluate the efficacy safety and tolerability of Aribrine combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive relapsed ovarian cancer
Detailed Description:
This is a phase II prospective single-center single-arm clinical study for platinum-sensitive recurrent ovarian cancer The main objective of this study is to evaluate the efficacy safety and tolerability of alibulin combined with carboplatin and bevacizumab in first-line treatment of platinum-sensitive recurrent ovarian cancer
Trial time plan The inclusion time of the plan 22 months Planned trial duration 24 months
1 Experimental drugs Aribrine mesylate injection carboplatin bevacizumab
2 Administration regimen Iribrine mesylate injection 14mgm2iv 30 min d1 d8 every 21 days Carboplatin AUC56 iv d1 every 21 days Bevacizumab 75mgkg iv 30-90 mind1 every 21 days The dose can be adjusted according to the state of the patient
Trial time plan The inclusion time of the plan 22 months Planned trial duration 24 months
1 Experimental drugs Aribrine mesylate injection carboplatin bevacizumab
2 Administration regimen Iribrine mesylate injection 14mgm2iv 30 min d1 d8 every 21 days Carboplatin AUC56 iv d1 every 21 days Bevacizumab 75mgkg iv 30-90 mind1 every 21 days The dose can be adjusted according to the state of the patient
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