Ignite Creation Date:
2024-05-06 @ 12:20 PM
Last Modification Date:
2024-10-26 @ 12:57 PM
Study NCT ID:
NCT03730012
Status:
COMPLETED
Last Update Posted:
2022-08-15
First Post:
2018-11-01
Brief Title:
A Study of ASP2215 Gilteritinib Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FMS-like Tyrosine Kinase FLT3 Mutated Acute Myeloid Leukemia AML
Sponsor:
Astellas Pharma Global Development Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
Phase 12 Study of ASP2215 Gilteritinib Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FLT3 Mutated Acute Myeloid Leukemia AML
Status:
COMPLETED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03070093
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
None
Brief Summary:
The purpose of this study was to determine the safety and tolerability of gilteritinib given in combination with atezolizumab in participants with relapsed or treatment refractory FMS-like tyrosine kinase 3 FLT3 mutated AML and to determine the composite complete remission CRc rate for participants who either discontinued the study or completed 2 cycles of gilteritinib given in combination with atezolizumab
This study also evaluated pharmacokinetics PK response to treatment remission and survival Adverse events AEs clinical laboratory results vital signs electrocardiograms ECGs and Eastern Cooperative Oncology Group ECOG performance status scores were also assessed
This study also evaluated pharmacokinetics PK response to treatment remission and survival Adverse events AEs clinical laboratory results vital signs electrocardiograms ECGs and Eastern Cooperative Oncology Group ECOG performance status scores were also assessed
Detailed Description:
This study was planned to have 2 phases
Phase 1
The phase 1 portion of this study was to establish the recommended phase 2 dose RP2D of gilteritinib given in combination with atezolizumab
Phase 2
The phase 2 portion of the study was to treat participants with gilteritinib and atezolizumab at the RP2D and was to be enrolled in two stages The first stage was to evaluate the remission rate and if a minimum rate was to be achieved a second stage of enrollment was to be continued
Phase 1
The phase 1 portion of this study was to establish the recommended phase 2 dose RP2D of gilteritinib given in combination with atezolizumab
Phase 2
The phase 2 portion of the study was to treat participants with gilteritinib and atezolizumab at the RP2D and was to be enrolled in two stages The first stage was to evaluate the remission rate and if a minimum rate was to be achieved a second stage of enrollment was to be continued
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