Ignite Creation Date:
2024-05-06 @ 6:06 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05546580
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2022-09-15
Brief Title:
Study of Iadademstat and Gilteritinib in Patients With RR AML With FMS-like Tyrosine Kinase Mutation FLT3 Mut
Sponsor:
Oryzon Genomics SA
Organization:
Oryzon Genomics SA
Study Overview
Official Title:
An EscalationExpansion Open Label Multicenter Study of Iadademstat and Gilteritinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia RR AML With FMS-like Tyrosine Kinase Mutation FLT3 Mut The FRIDA Study
Status:
RECRUITING
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:
FRIDA
Brief Summary:
Iadademstat is being studied as a treatment for subjects with Relapsed or Refractory Acute Myeloid Leukemia RR AML with FMS-like tyrosine kinase mutation FLT3 mut During the trial iadademstat will be given in combination with gilteritinib a drug that is already approved to treat patients with FLT3-mutated RR AML
Detailed Description:
This is an escalationexpansion open label single arm study to investigate the safety and the RP2D of the combination of iadademstat with gilteritinib in FLT3-mutated RR AML
This study consists of 2 parts A dose finding part to evaluate the safety tolerability pharmacokinetic PK pharmacodynamic PD and emerging activity of iadademstat and gilteritinib combination and to determine the pharmacologically-active dose ie the minimum safe and biologically active dose of iadademstat in combination with gilteritinib and an expansion part at the specific doses selected to evaluate the activity of iadademstat in combination with gilteritinib in patients with FLT3-mutated RR AML
This study consists of 2 parts A dose finding part to evaluate the safety tolerability pharmacokinetic PK pharmacodynamic PD and emerging activity of iadademstat and gilteritinib combination and to determine the pharmacologically-active dose ie the minimum safe and biologically active dose of iadademstat in combination with gilteritinib and an expansion part at the specific doses selected to evaluate the activity of iadademstat in combination with gilteritinib in patients with FLT3-mutated RR 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