[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481252":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":34,"locations":42,"responsibleParty":213,"collaborators":38,"id":215,"slug":38,"hasResults":216,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":216,"sex":222,"minAge":223,"maxAge":38,"enrollmentInfo":224,"targetDuration":38,"studyType":227,"phases":228,"briefSummary":230,"conditions":231,"keywords":234,"overallStatus":45,"whyStopped":38,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":240,"completionDateStruct":242,"leadSponsor":244,"locationsCount":245},{"fullName":5,"class":6},"Oryzon Genomics S.A.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Active arm","EXPERIMENTAL","iadademstat and gilteritinib",[13,14],"Drug: Iadademstat","Drug: Gilteritinib Oral 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States",{"type":51,"coordinates":52},"Point",[53,54],-111.78903,33.35283,{"lat":54,"lon":53},[57],{"name":58,"role":36,"phone":37,"phoneExt":38,"email":39},"Rajneesh Nath, MD",{"facility":60,"status":45,"city":61,"state":47,"zip":62,"country":49,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"The University of Arizona Cancer Center - North Campus","Tucson","85724-5024",{"type":51,"coordinates":64},[65,66],-110.92648,32.22174,{"lat":66,"lon":65},[69,72],{"name":70,"role":36,"phone":71,"phoneExt":38,"email":39},"Sharad Khurana, MD, MSc","+34935151313",{"name":73,"role":74,"phone":38,"phoneExt":38,"email":38},"Sharad Khurana, MD","PRINCIPAL_INVESTIGATOR",{"facility":76,"status":45,"city":77,"state":78,"zip":79,"country":49,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Sylvester Comprehensive Cancer Center","Miami","Florida","33136",{"type":51,"coordinates":81},[82,83],-80.19366,25.77427,{"lat":83,"lon":82},[86],{"name":87,"role":36,"phone":71,"phoneExt":38,"email":39},"Sangeetha Venugopal, MD",{"facility":89,"status":45,"city":77,"state":78,"zip":90,"country":49,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"Miami Cancer Institute","33176",{"type":51,"coordinates":92},[82,83],{"lat":83,"lon":82},[95],{"name":96,"role":36,"phone":37,"phoneExt":38,"email":39},"Guenther Koehne, MD, PhD",{"facility":98,"status":45,"city":99,"state":100,"zip":101,"country":49,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"The John Hopkins University School of Medicine","Baltimore","Maryland","21287-0013",{"type":51,"coordinates":103},[104,105],-76.61219,39.29038,{"lat":105,"lon":104},[108],{"name":109,"role":36,"phone":37,"phoneExt":38,"email":39},"Alexander J Ambiender, MD",{"facility":111,"status":45,"city":112,"state":113,"zip":114,"country":49,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Massachusetts General Hospital (MGH)","Boston","Massachusetts","02114",{"type":51,"coordinates":116},[117,118],-71.05977,42.35843,{"lat":118,"lon":117},[121],{"name":122,"role":36,"phone":71,"phoneExt":38,"email":39},"Amir Fathi, MD",{"facility":124,"status":45,"city":125,"state":126,"zip":127,"country":49,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Rutgers, The State University","Piscataway","New Jersey","08854",{"type":51,"coordinates":129},[130,131],-74.39904,40.49927,{"lat":131,"lon":130},[134],{"name":135,"role":36,"phone":37,"phoneExt":38,"email":39},"Neil D Palmisiano, MD, MS",{"facility":137,"status":45,"city":138,"state":138,"zip":139,"country":49,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital","New York","10029",{"type":51,"coordinates":141},[142,143],-74.00597,40.71427,{"lat":143,"lon":142},[146],{"name":147,"role":36,"phone":71,"phoneExt":38,"email":39},"Jonathan Feld, 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LLC","Nashville","Tennessee","37203",{"type":51,"coordinates":180},[181,182],-86.78444,36.16589,{"lat":182,"lon":181},[185],{"name":186,"role":36,"phone":71,"phoneExt":38,"email":39},"Stephen Strickland, MD",{"facility":188,"status":45,"city":189,"state":190,"zip":191,"country":49,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"West Virginia University","Morgantown","West Virginia","26506",{"type":51,"coordinates":193},[194,195],-79.9559,39.62953,{"lat":195,"lon":194},[198],{"name":199,"role":36,"phone":71,"phoneExt":38,"email":39},"Konstantinos Sdrimas, MD",{"facility":201,"status":45,"city":202,"state":203,"zip":204,"country":49,"cosmosGeoPoint":205,"geoPoint":209,"contacts":210},"Froedtert Hospital & The Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"type":51,"coordinates":206},[207,208],-87.90647,43.0389,{"lat":208,"lon":207},[211],{"name":212,"role":36,"phone":71,"phoneExt":38,"email":39},"Guru SG Murthy, MD",{"type":214,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100481252",false,"NCT05546580","Study of Iadademstat and Gilteritinib in Patients With R\u002FR AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)","An Escalation\u002FExpansion, Open Label, Multicenter Study of Iadademstat and Gilteritinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (R\u002FR AML) With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+): The FRIDA Study","FRIDA","Main Inclusion Criteria:\n\n* Diagnosis of primary AML or AML with myelodysplasia-related changes (AML-MRC)\n* Patient is in first or second relapse or has refractory disease. Patients must have had histologic verification of AML at the original diagnosis.\n* Patient must be positive for the following FLT3 mutations in bone marrow or PB: FLT3 internal tandem duplication (ITD), FLT3 tyrosine kinase domain (TKD) D835 or I836 or FLT3-ITD and specified FLT3-TKD.\n* ECOG performance status 0-2\n* Life expectancy of at least 3 months in the opinion of the investigator.\n* Normal hepatic and renal function.\n* Patient is able to swallow oral medications.\n* Female patients are postmenopausal, documented as surgically sterile, use two methods of contraception or practice true abstinence and have a negative urine pregnancy test at screening.\n* Male patients even if surgically sterilized agree to practice true abstinence or use highly effective barrier contraception.\n\nMain Exclusion Criteria:\n\n* Diagnosis of acute promyelocytic leukemia.\n* Known BCR-ABL-positive leukemia.\n* AML secondary to prior chemotherapy for other neoplasms (except for MDS).\n* AML that has relapsed after or is refractory to more than 2 lines of therapy.\n* Clinically active central nervous system leukemia or prior history of NCI CTCAE Grade ≥ 3 drug-related CNS toxicity.\n* Major surgery or radiation therapy within 4 weeks prior to the first study dose.\n* Prior treatment with iadademstat is not allowed. Treatment with any other agents with KDM1A\u002FLSD1 inhibitory activity is only allowed if treatment finalized at least 3 weeks prior to first dose on study. Previous treatment with FLT3 inhibitors is allowed in the following cases: midostaurin and sorafenib are allowed when used in first-line therapy regimen as part of induction, consolidation and\u002For maintenance: quizartinib and gilteritinib are allowed when used in first-line therapy regimen, as part of induction, consolidation and\u002For maintenance, ONLY if patients were not refractory to the drugs or if responding, relapse did not occur while on these drugs.\n* Patients not eligible to receive gilteritinib per label.\n* Prior treatment with 3 or more lines of AML therapy.\n* Treatment with any investigational products within 3 weeks prior to first dose of study treatment.\n* Uncontrolled hypertension or poorly controlled diabetes.\n* Evidence of active uncontrolled viral, bacterial, or systemic fungal infection.\n* Pregnant or lactating women.","ALL","18 Years",{"count":225,"type":226},50,"ESTIMATED","INTERVENTIONAL",[229],"PHASE1","Iadademstat is being studied as a treatment for subjects with Relapsed or Refractory Acute Myeloid Leukemia (R\u002FR 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\u002FR AML.",[232,233],"Acute Myeloid Leukemia, in Relapse","Acute Myeloid Leukemia Refractory",[235],"Acute Myeloid Leukemia, FLT3 mut","2024-07-26",{"date":238,"type":239},"2024-07-29","ACTUAL",{"date":241,"type":239},"2022-11-14",{"date":243,"type":226},"2025-11-30",{"name":5,"class":6},13]