Ignite Creation Date:
2024-05-06 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03552029
Status:
TERMINATED
Last Update Posted:
2022-05-20
First Post:
2018-05-17
Brief Title:
Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia AML
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase 1 Study of Milademetan in Combination With Quizartinib in Subjects With FLT3-ITD Mutant Acute Myeloid Leukemia That Are RelapsedRefractory or Newly Diagnosed and Unfit for Intensive Chemotherapy
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was terminated based on a business decision by the Sponsor
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Participants with AML that have gone into remission and come back relapsed or gone into remission with a number of leukemia cells still in their system refractory will be recruited for this study They will also be positive for FLT3-ITD mutation
Participants will receive a combined dose of quizartinib and milademetan that have not been approved by the US Food and Drug Administration yet m
The combination of these drugs will be provided in different amounts on defined days dosing schedules
It is expected that the combination of milademetan and quizartinib will be safe and well tolerated It is expected that the combination may fight the leukemia better than a single drug
The study will run for approximately 3 years There may be up to 156 participants
The study has 2 parts
Part 1 will test 24-36 participants in approximately 15 study centers globally Participants will receive two study drugs milademetan and quizartinib in different amounts on specific days Information will be gathered to see what dosing schedule of the drug combination is best maximum toleratedrecommended dose
Part 2 of the study will confirm the recommended dosing schedule identified in Part 1 is effective A larger number of participants will receive the recommended dose in approximately 15 additional sites worldwide as necessary based on the enrollment rate the population and the standard of care available to them at the time of enrollment
Participants will receive a combined dose of quizartinib and milademetan that have not been approved by the US Food and Drug Administration yet m
The combination of these drugs will be provided in different amounts on defined days dosing schedules
It is expected that the combination of milademetan and quizartinib will be safe and well tolerated It is expected that the combination may fight the leukemia better than a single drug
The study will run for approximately 3 years There may be up to 156 participants
The study has 2 parts
Part 1 will test 24-36 participants in approximately 15 study centers globally Participants will receive two study drugs milademetan and quizartinib in different amounts on specific days Information will be gathered to see what dosing schedule of the drug combination is best maximum toleratedrecommended dose
Part 2 of the study will confirm the recommended dosing schedule identified in Part 1 is effective A larger number of participants will receive the recommended dose in approximately 15 additional sites worldwide as necessary based on the enrollment rate the population and the standard of care available to them at the time of enrollment
Detailed Description:
None
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