Ignite Creation Date:
2024-05-06 @ 12:26 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03760081
Status:
COMPLETED
Last Update Posted:
2021-12-02
First Post:
2018-11-29
Brief Title:
A Study to Assess the Safety and Efficacy of ASP1650 a Monoclonal Antibody Targeting Claudin 6 CLDN6 in Male Subjects With Incurable Platinum Refractory Germ Cell Tumors
Sponsor:
Astellas Pharma Global Development Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase 2 Open-Label Single-Arm Multicenter Study to Assess the Safety and Efficacy of ASP1650 a Monoclonal Antibody Targeting Claudin 6 CLDN6 in Male Subjects With Incurable Platinum Refractory Germ Cell Tumors
Status:
COMPLETED
Status Verified Date:
2021-11
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 study was to establish the recommended phase 2 dose RP2D of ASP1650 Safety Lead-in Phase as well as evaluate the efficacy of ASP1650 as measured by confirmed objective response rate ORR phase 2 in participants with incurable platinum refractory germ cell tumors
This study also evaluated the following efficacy measures for confirmed objective response rate ORR clinical benefit rate CBR duration of response DOR and progression-free survival PFS as well as safety and tolerability the effect of ASP1650 on changes in serum beta human chorionic gonadotropin βhCG and alpha-fetoprotein AFP and the pharmacokinetics of ASP1650
This study also evaluated the following efficacy measures for confirmed objective response rate ORR clinical benefit rate CBR duration of response DOR and progression-free survival PFS as well as safety and tolerability the effect of ASP1650 on changes in serum beta human chorionic gonadotropin βhCG and alpha-fetoprotein AFP and the pharmacokinetics of ASP1650
Detailed Description:
The study consisted of 2 phases Safety Lead-in phase and phase 2 19 participants were enrolled in both phases
The Safety Lead-in phase of this study was to establish the tolerability of RP2D The RP2D determination was based on at least 6 evaluable participants at the RP2D as determined by the Dose Evaluation Committee DEC
Once RP2D had been established as tolerable 13 additional participants were enrolled in phase 2 to receive ASP1650 for up to a maximum of 12 cycles or until a study discontinuation criteria had been met whichever occurred earlier
The Safety Lead-in phase of this study was to establish the tolerability of RP2D The RP2D determination was based on at least 6 evaluable participants at the RP2D as determined by the Dose Evaluation Committee DEC
Once RP2D had been established as tolerable 13 additional participants were enrolled in phase 2 to receive ASP1650 for up to a maximum of 12 cycles or until a study discontinuation criteria had been met whichever occurred earlier
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