[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100481252":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":34,"locations":42,"responsibleParty":214,"collaborators":38,"id":216,"slug":217,"hasResults":218,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":218,"sex":224,"minAge":225,"maxAge":38,"enrollmentInfo":226,"targetDuration":38,"studyType":229,"phases":230,"briefSummary":232,"conditions":233,"keywords":236,"overallStatus":45,"whyStopped":38,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":247},{"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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MD",{"facility":112,"status":45,"city":113,"state":114,"zip":115,"country":49,"countryCode":50,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Massachusetts General Hospital (MGH)","Boston","Massachusetts","02114",{"type":52,"coordinates":117},[118,119],-71.05977,42.35843,{"lat":119,"lon":118},[122],{"name":123,"role":36,"phone":72,"phoneExt":38,"email":39},"Amir Fathi, MD",{"facility":125,"status":45,"city":126,"state":127,"zip":128,"country":49,"countryCode":50,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"Rutgers, The State University","Piscataway","New Jersey","08854",{"type":52,"coordinates":130},[131,132],-74.39904,40.49927,{"lat":132,"lon":131},[135],{"name":136,"role":36,"phone":37,"phoneExt":38,"email":39},"Neil D Palmisiano, MD, MS",{"facility":138,"status":45,"city":139,"state":139,"zip":140,"country":49,"countryCode":50,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Icahn School of Medicine at Mount Sinai and Mount Sinai Hospital","New 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PhD",{"facility":176,"status":45,"city":177,"state":178,"zip":179,"country":49,"countryCode":50,"cosmosGeoPoint":180,"geoPoint":184,"contacts":185},"Sarah Cannon Research Institute, LLC","Nashville","Tennessee","37203",{"type":52,"coordinates":181},[182,183],-86.78444,36.16589,{"lat":183,"lon":182},[186],{"name":187,"role":36,"phone":72,"phoneExt":38,"email":39},"Stephen Strickland, MD",{"facility":189,"status":45,"city":190,"state":191,"zip":192,"country":49,"countryCode":50,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"West Virginia University","Morgantown","West Virginia","26506",{"type":52,"coordinates":194},[195,196],-79.9559,39.62953,{"lat":196,"lon":195},[199],{"name":200,"role":36,"phone":72,"phoneExt":38,"email":39},"Konstantinos Sdrimas, MD",{"facility":202,"status":45,"city":203,"state":204,"zip":205,"country":49,"countryCode":50,"cosmosGeoPoint":206,"geoPoint":210,"contacts":211},"Froedtert Hospital & The Medical College of Wisconsin","Milwaukee","Wisconsin","53226",{"type":52,"coordinates":207},[208,209],-87.90647,43.0389,{"lat":209,"lon":208},[212],{"name":213,"role":36,"phone":72,"phoneExt":38,"email":39},"Guru SG Murthy, MD",{"type":215,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100481252","phase-1-study-of-iadademstat-and-gilteritinib-in-patients-with-rr-aml-with-fms-like-tyrosine-kinase-mutation-flt3-mut-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":227,"type":228},50,"ESTIMATED","INTERVENTIONAL",[231],"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.",[234,235],"Acute Myeloid Leukemia, in Relapse","Acute Myeloid Leukemia Refractory",[237],"Acute Myeloid Leukemia, FLT3 mut","2024-07-26",{"date":240,"type":241},"2024-07-29","ACTUAL",{"date":243,"type":241},"2022-11-14",{"date":245,"type":228},"2025-11-30",{"name":5,"class":6},13]