Ignite Creation Date:
2024-05-06 @ 3:32 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02310321
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2014-12-01
Brief Title:
A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase 12 Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2024-09
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 phase 1 part in this study was to determine the maximum tolerated dose MTD andor recommended expansion dose RED of ASP2215 concomitant with cytarabineidarubicin as induction chemotherapy based on the status of the onset of dose-limiting toxicity DLT in newly diagnosed Acute Myeloid Leukemia AML subjects Phase 1 part also evaluated safety and tolerability and characterized the pharmacokinetic PK parameters of ASP2215 concomitant with induction and consolidation chemotherapy as well as evaluated the PK parameters of cytarabine concomitant with ASP2215
The purpose of phase 2 part was to evaluate efficacy of ASP2215 in combination with induction therapy Phase 2 cohort also evaluated safety and characterized the PK parameters of ASP2215 in combination with induction and consolidation therapy followed by maintenance therapy in newly diagnosed FLT3-mutated AML subjects
The purpose of phase 2 part was to evaluate efficacy of ASP2215 in combination with induction therapy Phase 2 cohort also evaluated safety and characterized the PK parameters of ASP2215 in combination with induction and consolidation therapy followed by maintenance therapy in newly diagnosed FLT3-mutated AML subjects
Detailed Description:
This study was composed of Phase 1 part the dose-evaluation part and the expansion part and Phase 2 part
In the dose-evaluation part of Phase 1 part at least 3 subjects received ASP2215 at each dose low middle and high for determination of MTD andor RED Treatment of AML in Phase 1 part was composed of 3 periods of therapy remission induction consolidation and maintenance The decision of whether or not to proceed to the next dose was made based on the occurrence of DLT during Cycle 1 of the induction period
In the expansion part of Phase 1 part a maximum of 3 subjects received ASP2215 at RED that had been recommended in the dose-evaluation part and the safety was assessed based on the onset of DLTs during Cycle 1 of the induction and consolidation periods
In Phase 2 part Subjects received ASP2215 at the recommended dose established in Phase 1 part The target population was limited to newly diagnosed FLT3-mutated AML
In the dose-evaluation part of Phase 1 part at least 3 subjects received ASP2215 at each dose low middle and high for determination of MTD andor RED Treatment of AML in Phase 1 part was composed of 3 periods of therapy remission induction consolidation and maintenance The decision of whether or not to proceed to the next dose was made based on the occurrence of DLT during Cycle 1 of the induction period
In the expansion part of Phase 1 part a maximum of 3 subjects received ASP2215 at RED that had been recommended in the dose-evaluation part and the safety was assessed based on the onset of DLTs during Cycle 1 of the induction and consolidation periods
In Phase 2 part Subjects received ASP2215 at the recommended dose established in Phase 1 part The target population was limited to newly diagnosed FLT3-mutated AML
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?:
True
Is an FDA AA801 Violation?:
None