Ignite Creation Date:
2024-05-06 @ 8:06 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02668653
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2016-01-22
Brief Title:
Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD Acute Myeloid Leukemia AML
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase 3 Double-Blind Placebo-controlled Study of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy and Administered as Continuation Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD Acute Myeloid Leukemia QuANTUM First
Status:
COMPLETED
Status Verified Date:
2024-07
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:
QuANTUM-First
Brief Summary:
Quizartinib is an experimental drug It is not approved for regular use It can only be used in medical research
Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer FLT3-ITD AML
Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy
Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer FLT3-ITD AML
Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy
Detailed Description:
This is a phase 3 randomized double-blind placebo-control global study The purpose of this study is to compare the effect of quizartinib versus placebo administered with standard induction and consolidation chemotherapy then administered as continuation therapy for up to 36 cycles on overall survival in subjects with FLT3-internal tandem duplication ITD positive 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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-004856-24 | EUDRACT_NUMBER | None | None |
| 173667 | REGISTRY | JAPIC CTI | None |