← Back to Search

Tyrosine Kinase Inhibitor

Iadademstat + Gilteritinib for Acute Myeloid Leukemia (FRIDA Trial)

Phase 1
Recruiting
Research Sponsored by Oryzon Genomics S.A.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status 0-2
Normal hepatic and renal function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

FRIDA Trial Summary

This trial is testing a new combination of drugs to treat FLT3-mutated R/R AML. The goal is to find the highest dose of the drugs that is still safe, and to see how well the combination works.

Who is the study for?
This trial is for adults with Acute Myeloid Leukemia (AML) that has returned or hasn't responded to treatment, and they must have specific FLT3 mutations. They should be able to perform daily activities with ease to moderate difficulty, have a life expectancy of at least 3 months, and normal liver and kidney function. Women must not be pregnant and use contraception; men agree to use barrier contraception.Check my eligibility
What is being tested?
The study tests Iadademstat in combination with Gilteritinib, an approved drug for AML with FLT3 mutation. It's aimed at patients whose AML has relapsed or is refractory. The goal is to see if adding Iadademstat can improve outcomes compared to using Gilteritinib alone.See study design
What are the potential side effects?
Potential side effects may include typical reactions from cancer treatments such as fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems, liver or kidney issues, and possibly others related specifically to the drugs being tested.

FRIDA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take care of myself and perform daily activities.
Select...
My liver and kidney functions are normal.
Select...
I can swallow pills.
Select...
I am a male and will practice abstinence or use effective contraception.
Select...
I have been diagnosed with AML or AML with changes related to myelodysplasia.
Select...
My AML has returned for the first or second time, or is not responding to treatment.
Select...
My leukemia has specific FLT3 mutations.

FRIDA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events (AE)
Iadademstat Cmax
Laboratory value abnormalities and/or adverse events (AE)
+8 more
Secondary outcome measures
Duration of Remission (DoR)
Event-Free-Survival (EFS)
Overall Survival (OS)
+4 more

FRIDA Trial Design

1Treatment groups
Experimental Treatment
Group I: Active armExperimental Treatment2 Interventions
iadademstat and gilteritinib

Find a Location

Who is running the clinical trial?

Oryzon Genomics S.A.Lead Sponsor
3 Previous Clinical Trials
222 Total Patients Enrolled
Douglas Faller, PhDStudy ChairOryzon Genomics

Media Library

Gilteritinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05546580 — Phase 1
Acute Myelogenous Leukemia Research Study Groups: Active arm
Acute Myelogenous Leukemia Clinical Trial 2023: Gilteritinib Highlights & Side Effects. Trial Name: NCT05546580 — Phase 1
Gilteritinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05546580 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being accepted for this trial?

"According to clinicaltrials.gov, this clinical trial is no longer actively enrolling participants at present time. Originally posted on October 15th 2022 and most recently updated on September 15th 2022; while the study is not taking any more patients, there are still 1466 other trials that are currently recruiting individuals."

Answered by AI

When used medicinally, what potential risks does Iadademstat present?

"The safety of Iadademstat was rated as 1, due to its Phase 1 status and the lack of significant data backing up both efficacy and safety."

Answered by AI

What does the research team hope to accomplish through this experiment?

"Primary outcomes of this 18 month study include monitoring laboratory values and adverse events. Secondary measures will assess the transplantation rate, overall response rates, and transfusion independence percentages."

Answered by AI
~19 spots leftby Jan 2025