Ignite Creation Date:
2024-10-26 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06502145
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Iadademstat With Hypomethylating Agent in Patients With Myelodysplastic Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Iadademstat With Hypomethylating Agent in Patients With Myelodysplastic Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase I study with a primary objective of determining the recommended phase II dose of iadademstat with azacitidine in adult subjects with myelodysplastic syndrome MDS
Detailed Description:
This is a single-arm open-label phase 1 study designed to evaluate the safety of iadademstat with azacitidine therapy The trial will follow a 33 phase 1 dose-escalation design
First three participants are given a low dose of the experimental treatment and monitored for pre-specified toxicity events If 0 participants experience one of these toxicity events then the next group of three participants is enrolled at a higher dose If two or three participants experience toxicity then the next group of three participants is enrolled at a lower dose or the study ends If one participant experiences toxicity another group of three participants is enrolled at the same dose hence the name 33 if one or more of those participants experience toxicity then the dose is lowered for the next group of the study ends Otherwise if 0 of the additional participants experience toxicity the next group is enrolled at a higher dose
First three participants are given a low dose of the experimental treatment and monitored for pre-specified toxicity events If 0 participants experience one of these toxicity events then the next group of three participants is enrolled at a higher dose If two or three participants experience toxicity then the next group of three participants is enrolled at a lower dose or the study ends If one participant experiences toxicity another group of three participants is enrolled at the same dose hence the name 33 if one or more of those participants experience toxicity then the dose is lowered for the next group of the study ends Otherwise if 0 of the additional participants experience toxicity the next group is enrolled at a higher dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None