Spots Global Cancer Trial Database for Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)
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Trial Identification
Brief Title: Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)
Official Title: An Escalation/Expansion, Open Label, Multicenter Study of Iadademstat and Gilteritinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+): The FRIDA Study
Study ID: NCT05546580
Study Description
Brief Summary: Iadademstat is being studied as a treatment for subjects with Relapsed or Refractory Acute Myeloid Leukemia (R/R 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 R/R AML.
Detailed Description: This is an escalation/expansion, open label, single arm, study to investigate the safety and the RP2D of the combination of iadademstat with gilteritinib in FLT3-mutated R/R 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 (i.e., the minimum safe and biologically active dose) of iadademstat in combination with gilteritinib, and an expansion part at the specific dose/s selected to evaluate the activity of iadademstat in combination with gilteritinib in patients with FLT3-mutated R/R AML.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
The University of Arizona Cancer Center - North Campus, Tucson, Arizona, United States
Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Miami Cancer Institute, Miami, Florida, United States
The John Hopkins University School of Medicine, Baltimore, Maryland, United States
Massachusetts General Hospital (MGH), Boston, Massachusetts, United States
Rutgers, The State University, Piscataway, New Jersey, United States
Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital, New York, New York, United States
The Ohio State University Wexner Medical Center, Columbus, Ohio, United States
Oregon Health & Science University, Portland, Oregon, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute, LLC, Nashville, Tennessee, United States
West Virginia University, Morgantown, West Virginia, United States
Froedtert Hospital & The Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Douglas Faller, PhD
Affiliation: Oryzon Genomics
Role: STUDY_CHAIR
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