Ignite Creation Date:
2024-05-06 @ 3:33 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02319369
Status:
TERMINATED
Last Update Posted:
2021-10-11
First Post:
2014-12-15
Brief Title:
Safety Tolerability and Pharmacokinetics of Milademetan Alone and With 5-Azacitidine AZA in Acute Myelogenous Leukemia AML or High-Risk Myelodysplastic Syndrome MDS
Sponsor:
Daiichi Sankyo
Organization:
Daiichi Sankyo
Study Overview
Official Title:
A Phase 1 Study of Milademetan DS 3032b an Oral MDM2 Inhibitor In Dose Escalation as a Single Agent and In Dose EscalationExpansion In Combination With 5 Azacitidine In Subjects With Acute Myelogenous Leukemia AML or High Risk Myelodysplastic Syndrome MDS
Status:
TERMINATED
Status Verified Date:
2021-09
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:
This study will take place in parts
Dose Escalation Part 1 Participants receive milademetan alone with different dose schedules
Dose Escalation Part 1A Participants receive milademetan in combination with 5-azacytidine AZA with different dose schedules
The recommended dose for Part 2 will be selected
Dose Expansion Part 2 After Part 1A participants will receive the recommended Part 2 dose schedule There will be three groups - those with
1 refractory or relapsed acute myelogenous leukemia AML
2 newly diagnosed AML unfit for intensive chemotherapy
3 high-risk myelodysplastic syndrome MDS
End-of-Study Follow-Up Safety information will be collected until 30 days after the last treatment This is the end of the study
The recommended dose for the next study will be selected
Dose Escalation Part 1 Participants receive milademetan alone with different dose schedules
Dose Escalation Part 1A Participants receive milademetan in combination with 5-azacytidine AZA with different dose schedules
The recommended dose for Part 2 will be selected
Dose Expansion Part 2 After Part 1A participants will receive the recommended Part 2 dose schedule There will be three groups - those with
1 refractory or relapsed acute myelogenous leukemia AML
2 newly diagnosed AML unfit for intensive chemotherapy
3 high-risk myelodysplastic syndrome MDS
End-of-Study Follow-Up Safety information will be collected until 30 days after the last treatment This is the end of the study
The recommended dose for the next study will be selected
Detailed Description:
The primary analysis will occur after all participants have either discontinued the study or completed at least 6 months of treatment After the primary analysis the main study will be closed Participants who are still on study at least 6 months after enrollment of the last participant in the study may be eligible to continue receiving study drug in a separate extension phase of the protocol
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