[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516228":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":35,"centralContacts":53,"locations":59,"responsibleParty":656,"collaborators":35,"id":658,"slug":659,"hasResults":660,"nctId":661,"briefTitle":662,"officialTitle":663,"acronym":35,"eligibilityCriteria":664,"healthyVolunteers":660,"sex":665,"minAge":666,"maxAge":35,"enrollmentInfo":667,"targetDuration":35,"studyType":670,"phases":671,"briefSummary":673,"conditions":674,"keywords":35,"overallStatus":62,"whyStopped":35,"lastUpdateSubmitDate":687,"lastUpdatePostDateStruct":688,"startDateStruct":691,"completionDateStruct":693,"leadSponsor":695,"locationsCount":696},{"fullName":5,"class":6},"Kura Oncology, Inc.","INDUSTRY",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1a","EXPERIMENTAL","Oral ziftomenib; sequential cohorts of escalating dose levels of ziftomenib to identify the safety and tolerability of the combination regimens. Participants will be enrolled in 1 of 5 dose escalation cohorts:\n\nA-1: Participants with a NPM1 mutation: ziftomenib plus FLAG-IDA\n\nA-2: Participants with a NPM1 mutation: ziftomenib plus low-dose cytarabine (LDAC)\n\nA-3: Participants with a NPM1 mutation: ziftomenib plus gilteritinib\n\nB-1: Participants with a KMT2A rearrangement: ziftomenib plus FLAG-IDA\n\nB-2: Participants with a KMT2A rearrangement: ziftomenib plus low-dose cytarabine (LDAC)",[13,14,15,16,17,18],"Drug: Ziftomenib","Drug: Fludarabine","Drug: Idarubicin","Drug: Cytarabine","Drug: Gilteritinib","Biological: Granulocyte colony-stimulating factor",{"label":20,"type":10,"description":21,"interventionNames":22},"Phase 1b","Oral ziftomenib; Following the determination of the maximum tolerated dose in Phase 1a, participants will be enrolled in 1 of 5 dose validation\u002Fexpansion cohorts:\n\nA-1: Participants with a NPM1 mutation: ziftomenib plus FLAG-IDA\n\nA-2: Participants with a NPM1 mutation: ziftomenib plus low-dose cytarabine (LDAC)\n\nA-3: Participants with a NPM1 mutation: ziftomenib plus gilteritinib\n\nB-1: Participants with a KMT2A rearrangement: ziftomenib plus FLAG-IDA\n\nB-2: Participants with a KMT2A rearrangement: ziftomenib plus low-dose cytarabine (LDAC)",[13,14,15,16,17,18],[24,31,36,39,43,48],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Ziftomenib","Oral administration",[9,20],[30],"KO-539",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Fludarabine","Intravenous infusion",[9,20],null,{"type":25,"name":37,"description":33,"armGroupLabels":38,"otherNames":35},"Idarubicin",[9,20],{"type":25,"name":40,"description":41,"armGroupLabels":42,"otherNames":35},"Cytarabine","Intravenous Infusion",[9,20],{"type":25,"name":44,"description":27,"armGroupLabels":45,"otherNames":46},"Gilteritinib",[9,20],[47],"Xospata",{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":35},"BIOLOGICAL","Granulocyte colony-stimulating factor","Subcutaneous injection",[9,20],[54],{"name":55,"role":56,"phone":57,"phoneExt":35,"email":58},"Kura Medical Information","CONTACT","844-KURAONC (844-587-2662)","medinfo@kuraoncology.com",[60,78,93,104,118,127,142,157,171,184,198,212,222,237,252,262,272,282,292,302,317,331,340,351,362,376,389,403,418,432,442,461,476,490,503,518,533,543,553,569,583,597,614,628,642],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Banner MD Anderson Cancer Center","RECRUITING","Gilbert","Arizona","85234","United States","US",{"type":69,"coordinates":70},"Point",[71,72],-111.78903,33.35283,{"lat":72,"lon":71},[75],{"name":35,"role":56,"phone":76,"phoneExt":35,"email":77},"480-256-6444","BMDACCResearch@bannerhealth.com",{"facility":79,"status":62,"city":80,"state":81,"zip":82,"country":66,"countryCode":67,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"USC Norris Comprehensive Cancer Center","Los Angeles","California","90089",{"type":69,"coordinates":84},[85,86],-118.24368,34.05223,{"lat":86,"lon":85},[89],{"name":90,"role":56,"phone":91,"phoneExt":35,"email":92},"Christine Duran","323-865-0371","duran_c@med.usc.edu",{"facility":94,"status":62,"city":80,"state":81,"zip":95,"country":66,"countryCode":67,"cosmosGeoPoint":96,"geoPoint":98,"contacts":99},"UCLA Health - Bowyer Oncology Center","90095",{"type":69,"coordinates":97},[85,86],{"lat":86,"lon":85},[100],{"name":101,"role":56,"phone":102,"phoneExt":35,"email":103},"Bruck Habtemariam","310-794-0242","bhabtemariam@mednet.ucla.edu",{"facility":105,"status":62,"city":106,"state":81,"zip":107,"country":66,"countryCode":67,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"UC Irvine Health Chao Family Comprehensive Cancer Center","Orange","92868",{"type":69,"coordinates":109},[110,111],-117.85311,33.78779,{"lat":111,"lon":110},[114],{"name":115,"role":56,"phone":116,"phoneExt":35,"email":117},"Research Line","877-827-8839","ucstudy@hs.uci.edu",{"facility":119,"status":62,"city":120,"state":81,"zip":121,"country":66,"countryCode":67,"cosmosGeoPoint":122,"geoPoint":126,"contacts":35},"University of California San Francisco","San Francisco","94115",{"type":69,"coordinates":123},[124,125],-122.41942,37.77493,{"lat":125,"lon":124},{"facility":128,"status":62,"city":129,"state":130,"zip":131,"country":66,"countryCode":67,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Colorado Blood Cancer Institute","Denver","Colorado","80218",{"type":69,"coordinates":133},[134,135],-104.9847,39.73915,{"lat":135,"lon":134},[138],{"name":139,"role":56,"phone":140,"phoneExt":35,"email":141},"New Patient Contact","720-754-4835","PLSMDLCBCINewPatient@HCAHealthcare.com",{"facility":143,"status":62,"city":144,"state":145,"zip":146,"country":66,"countryCode":67,"cosmosGeoPoint":147,"geoPoint":151,"contacts":152},"Smilow Cancer Hospital at Yale New Haven","New Haven","Connecticut","06511",{"type":69,"coordinates":148},[149,150],-72.92816,41.30815,{"lat":150,"lon":149},[153],{"name":154,"role":56,"phone":155,"phoneExt":35,"email":156},"Farah Fasihuddin","203-737-3472","farah.fasihuddin@yale.edu",{"facility":158,"status":62,"city":159,"state":160,"zip":161,"country":66,"countryCode":67,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Emory Healthcare - The Emory Clinic","Atlanta","Georgia","30322",{"type":69,"coordinates":163},[164,165],-84.38798,33.749,{"lat":165,"lon":164},[168],{"name":169,"role":56,"phone":35,"phoneExt":35,"email":170},"Gigi Stoneback","gissela.blanco.stoneback@emory.edu",{"facility":172,"status":62,"city":173,"state":160,"zip":174,"country":66,"countryCode":67,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"Georgia Cancer Center at Augusta University","Augusta","30912",{"type":69,"coordinates":176},[177,178],-81.97484,33.47097,{"lat":178,"lon":177},[181],{"name":182,"role":56,"phone":35,"phoneExt":35,"email":183},"Amanda Spires","amspires@augusta.edu",{"facility":185,"status":62,"city":186,"state":187,"zip":188,"country":66,"countryCode":67,"cosmosGeoPoint":189,"geoPoint":193,"contacts":194},"Robert H. Lurie Comprehensive Cancer Center of Northwestern University","Chicago","Illinois","60611",{"type":69,"coordinates":190},[191,192],-87.65005,41.85003,{"lat":192,"lon":191},[195],{"name":35,"role":56,"phone":196,"phoneExt":35,"email":197},"312-695-9367","cancer@northwestern.edu",{"facility":199,"status":62,"city":200,"state":187,"zip":201,"country":66,"countryCode":67,"cosmosGeoPoint":202,"geoPoint":206,"contacts":207},"Loyola University Medical Center","Maywood","60153",{"type":69,"coordinates":203},[204,205],-87.84312,41.8792,{"lat":205,"lon":204},[208],{"name":209,"role":56,"phone":210,"phoneExt":35,"email":211},"Esteban Orozco Espiricueta","708-327-3221","eespiricuetaorozco@luc.edu",{"facility":213,"status":214,"city":215,"state":187,"zip":216,"country":66,"countryCode":67,"cosmosGeoPoint":217,"geoPoint":221,"contacts":35},"Simmons Cancer Institute","WITHDRAWN","Springfield","62702",{"type":69,"coordinates":218},[219,220],-89.64371,39.80172,{"lat":220,"lon":219},{"facility":223,"status":62,"city":224,"state":225,"zip":226,"country":66,"countryCode":67,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"University of Iowa Hospitals & Clinics","Iowa City","Iowa","52242",{"type":69,"coordinates":228},[229,230],-91.53017,41.66113,{"lat":230,"lon":229},[233],{"name":234,"role":56,"phone":235,"phoneExt":35,"email":236},"Grerk Sutamtewagul","319-353-8383","Grerk-sutamtewagul@uiowa.edu",{"facility":238,"status":62,"city":239,"state":240,"zip":241,"country":66,"countryCode":67,"cosmosGeoPoint":242,"geoPoint":246,"contacts":247},"The University of Kansas Cancer Center","Kansas City","Kansas","66160",{"type":69,"coordinates":243},[244,245],-94.62746,39.11417,{"lat":245,"lon":244},[248],{"name":249,"role":56,"phone":250,"phoneExt":35,"email":251},"KUCC Navigation Team","913-588-3671","kucc_navigation@kumc.edu",{"facility":253,"status":62,"city":254,"state":255,"zip":256,"country":66,"countryCode":67,"cosmosGeoPoint":257,"geoPoint":261,"contacts":35},"Beth Israel Deaconess Medical Center","Boston","Massachusetts","02215",{"type":69,"coordinates":258},[259,260],-71.05977,42.35843,{"lat":260,"lon":259},{"facility":263,"status":62,"city":264,"state":265,"zip":266,"country":66,"countryCode":67,"cosmosGeoPoint":267,"geoPoint":271,"contacts":35},"Karmanos Cancer Institute","Detroit","Michigan","48201",{"type":69,"coordinates":268},[269,270],-83.04575,42.33143,{"lat":270,"lon":269},{"facility":273,"status":62,"city":264,"state":265,"zip":274,"country":66,"countryCode":67,"cosmosGeoPoint":275,"geoPoint":277,"contacts":278},"Henry Ford Cancer Institute","48202",{"type":69,"coordinates":276},[269,270],{"lat":270,"lon":269},[279],{"name":280,"role":56,"phone":35,"phoneExt":35,"email":281},"Kristyn Dailey","KDailey6@hfhs.org",{"facility":283,"status":62,"city":284,"state":285,"zip":286,"country":66,"countryCode":67,"cosmosGeoPoint":287,"geoPoint":291,"contacts":35},"Washington University School of Medicine","St Louis","Missouri","63110",{"type":69,"coordinates":288},[289,290],-90.19789,38.62727,{"lat":290,"lon":289},{"facility":293,"status":62,"city":294,"state":295,"zip":296,"country":66,"countryCode":67,"cosmosGeoPoint":297,"geoPoint":301,"contacts":35},"University of Nebraska Medical Center","Omaha","Nebraska","68198",{"type":69,"coordinates":298},[299,300],-95.94043,41.25626,{"lat":300,"lon":299},{"facility":303,"status":62,"city":304,"state":305,"zip":306,"country":66,"countryCode":67,"cosmosGeoPoint":307,"geoPoint":311,"contacts":312},"John Theurer Cancer Center at Hackensack University Medical Center","Hackensack","New Jersey","07601",{"type":69,"coordinates":308},[309,310],-74.04347,40.88593,{"lat":310,"lon":309},[313],{"name":314,"role":56,"phone":315,"phoneExt":35,"email":316},"Oncology Clinical Reference Referral Office","551-996-1777","OncologyResearchReferral@hmhn.org",{"facility":318,"status":62,"city":319,"state":320,"zip":321,"country":66,"countryCode":67,"cosmosGeoPoint":322,"geoPoint":326,"contacts":327},"Roswell Park Comprehensive Cancer Center","Buffalo","New York","14263",{"type":69,"coordinates":323},[324,325],-78.87837,42.88645,{"lat":325,"lon":324},[328],{"name":35,"role":56,"phone":329,"phoneExt":35,"email":330},"877-275-7724","askrpci@roswellpark.org",{"facility":332,"status":62,"city":333,"state":320,"zip":334,"country":66,"countryCode":67,"cosmosGeoPoint":335,"geoPoint":339,"contacts":35},"Northwell Health, LLC PRIME","Lake Success","11042",{"type":69,"coordinates":336},[337,338],-73.71763,40.77066,{"lat":338,"lon":337},{"facility":341,"status":62,"city":320,"state":320,"zip":342,"country":66,"countryCode":67,"cosmosGeoPoint":343,"geoPoint":347,"contacts":348},"Memorial Sloan Kettering Cancer Center","10021",{"type":69,"coordinates":344},[345,346],-74.00597,40.71427,{"lat":346,"lon":345},[349],{"name":35,"role":56,"phone":350,"phoneExt":35,"email":35},"646-888-4167",{"facility":352,"status":62,"city":320,"state":320,"zip":353,"country":66,"countryCode":67,"cosmosGeoPoint":354,"geoPoint":356,"contacts":357},"Weill Cornell Medical College-NY Presbyterian Hospital","10065",{"type":69,"coordinates":355},[345,346],{"lat":346,"lon":345},[358],{"name":359,"role":56,"phone":360,"phoneExt":35,"email":361},"Tania Curcio","212-746-2571","tjc9003@med.cornell.edu",{"facility":363,"status":62,"city":364,"state":320,"zip":365,"country":66,"countryCode":67,"cosmosGeoPoint":366,"geoPoint":370,"contacts":371},"Wilmot Cancer Institute, University of Rochester","Rochester","14642",{"type":69,"coordinates":367},[368,369],-77.61556,43.15478,{"lat":369,"lon":368},[372],{"name":373,"role":56,"phone":374,"phoneExt":35,"email":375},"Clinical Trials Referral Office","855-776-0015","wcictoresearch@urmc.rochester.edu",{"facility":377,"status":62,"city":378,"state":320,"zip":379,"country":66,"countryCode":67,"cosmosGeoPoint":380,"geoPoint":384,"contacts":385},"Stony Brook Cancer Center","Stony Brook","11794",{"type":69,"coordinates":381},[382,383],-73.14094,40.92565,{"lat":383,"lon":382},[386],{"name":387,"role":56,"phone":35,"phoneExt":35,"email":388},"Zita Makselyte","zita.makselyte@stonybrookmedicine.edu",{"facility":390,"status":62,"city":391,"state":392,"zip":393,"country":66,"countryCode":67,"cosmosGeoPoint":394,"geoPoint":398,"contacts":399},"Atrium Health Levine Cancer Center","Charlotte","North Carolina","60201",{"type":69,"coordinates":395},[396,397],-80.84313,35.22709,{"lat":397,"lon":396},[400],{"name":401,"role":56,"phone":35,"phoneExt":35,"email":402},"Chari Granger","Chari.Granger@atriumhealth.org",{"facility":404,"status":62,"city":405,"state":406,"zip":407,"country":66,"countryCode":67,"cosmosGeoPoint":408,"geoPoint":412,"contacts":413},"UH Seidman Cancer Center","Cleveland","Ohio","44106",{"type":69,"coordinates":409},[410,411],-81.69541,41.4995,{"lat":411,"lon":410},[414],{"name":415,"role":56,"phone":416,"phoneExt":35,"email":417},"Leslie Ortega","216-844-8129","ctgov@case.edu",{"facility":419,"status":62,"city":420,"state":421,"zip":422,"country":66,"countryCode":67,"cosmosGeoPoint":423,"geoPoint":427,"contacts":428},"OU Health Stephenson Cancer Center","Oklahoma City","Oklahoma","73104",{"type":69,"coordinates":424},[425,426],-97.51643,35.46756,{"lat":426,"lon":425},[429],{"name":430,"role":56,"phone":35,"phoneExt":35,"email":431},"Cynthia J Lowery","Cynthia-Lowery@ouhsc.edu",{"facility":433,"status":214,"city":434,"state":435,"zip":436,"country":66,"countryCode":67,"cosmosGeoPoint":437,"geoPoint":441,"contacts":35},"Lehigh Valley Topper Cancer Institute","Allentown","Pennsylvania","18103",{"type":69,"coordinates":438},[439,440],-75.49018,40.60843,{"lat":440,"lon":439},{"facility":443,"status":62,"city":444,"state":445,"zip":446,"country":66,"countryCode":67,"cosmosGeoPoint":447,"geoPoint":451,"contacts":452},"Prisma Health","Greenville","South Carolina","29615",{"type":69,"coordinates":448},[449,450],-82.39401,34.85262,{"lat":450,"lon":449},[453,457],{"name":454,"role":56,"phone":455,"phoneExt":35,"email":456},"Lisa Johnson","864-455-3735","lisa.johnson@prismahealth.org",{"name":458,"role":56,"phone":459,"phoneExt":35,"email":460},"Fiona Davidson","864-455-3737","fiona.davidson@prismahealth.org",{"facility":462,"status":62,"city":463,"state":464,"zip":465,"country":66,"countryCode":67,"cosmosGeoPoint":466,"geoPoint":470,"contacts":471},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":69,"coordinates":467},[468,469],-86.78444,36.16589,{"lat":469,"lon":468},[472],{"name":473,"role":56,"phone":474,"phoneExt":35,"email":475},"Recruitment and Eligibility Office","800-811-8480","cip@vumc.org",{"facility":477,"status":62,"city":478,"state":479,"zip":480,"country":66,"countryCode":67,"cosmosGeoPoint":481,"geoPoint":485,"contacts":486},"Texas Oncology - Baylor Charles A. Sammons Cancer Center","Dallas","Texas","75246",{"type":69,"coordinates":482},[483,484],-96.80667,32.78306,{"lat":484,"lon":483},[487],{"name":488,"role":56,"phone":35,"phoneExt":35,"email":489},"Christine Terraciano","Christine.Terraciano@usoncology.com",{"facility":491,"status":62,"city":492,"state":479,"zip":493,"country":66,"countryCode":67,"cosmosGeoPoint":494,"geoPoint":498,"contacts":499},"MD Anderson Cancer Center","Houston","77030",{"type":69,"coordinates":495},[496,497],-95.36327,29.76328,{"lat":497,"lon":496},[500],{"name":501,"role":56,"phone":35,"phoneExt":35,"email":502},"Ann Mosely","aemosley@mdanderson.org",{"facility":504,"status":62,"city":505,"state":506,"zip":507,"country":66,"countryCode":67,"cosmosGeoPoint":508,"geoPoint":512,"contacts":513},"University of Vermont","Burlington","Vermont","05401",{"type":69,"coordinates":509},[510,511],-73.21207,44.47588,{"lat":511,"lon":510},[514],{"name":515,"role":56,"phone":516,"phoneExt":35,"email":517},"Stephanie Stahl","802-656-2021","Stephanie.Stahl@uvmhealth.org",{"facility":519,"status":62,"city":520,"state":521,"zip":522,"country":66,"countryCode":67,"cosmosGeoPoint":523,"geoPoint":527,"contacts":528},"University of Virginia Comprehensive Cancer Center","Charlottesville","Virginia","22903",{"type":69,"coordinates":524},[525,526],-78.47668,38.02931,{"lat":526,"lon":525},[529],{"name":530,"role":56,"phone":531,"phoneExt":35,"email":532},"Avani Hopkins","434-243-8108","Ajh7jqe@uvahealth.org",{"facility":534,"status":62,"city":535,"state":536,"zip":537,"country":66,"countryCode":67,"cosmosGeoPoint":538,"geoPoint":542,"contacts":35},"University of Washington","Seattle","Washington","98109",{"type":69,"coordinates":539},[540,541],-122.33207,47.60621,{"lat":541,"lon":540},{"facility":544,"status":62,"city":545,"state":546,"zip":547,"country":66,"countryCode":67,"cosmosGeoPoint":548,"geoPoint":552,"contacts":35},"Froedtert & Medical College Clinics","Milwaukee","Wisconsin","53226",{"type":69,"coordinates":549},[550,551],-87.90647,43.0389,{"lat":551,"lon":550},{"facility":554,"status":62,"city":555,"state":35,"zip":556,"country":557,"countryCode":558,"cosmosGeoPoint":559,"geoPoint":563,"contacts":564},"IRCCS Azienda Ospedaliero-Universitaria do Bologna - Policlinico di Sant'Orsola","Bologna","40138","Italy","IT",{"type":69,"coordinates":560},[561,562],11.33875,44.49381,{"lat":562,"lon":561},[565],{"name":566,"role":56,"phone":567,"phoneExt":35,"email":568},"Cristina Papayannidis","39512144177","cristina.papayannidis@unibo.it",{"facility":570,"status":62,"city":571,"state":35,"zip":572,"country":557,"countryCode":558,"cosmosGeoPoint":573,"geoPoint":577,"contacts":578},"Ospedale Santa Maria delle Croci","Ravenna","48121",{"type":69,"coordinates":574},[575,576],12.20121,44.41344,{"lat":576,"lon":575},[579],{"name":580,"role":56,"phone":581,"phoneExt":35,"email":582},"Francesco Lanza","390544285734","francesco.lanza@auslromagna.it",{"facility":584,"status":62,"city":585,"state":35,"zip":586,"country":557,"countryCode":558,"cosmosGeoPoint":587,"geoPoint":591,"contacts":592},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","Roma","00168",{"type":69,"coordinates":588},[589,590],11.10642,44.99364,{"lat":590,"lon":589},[593],{"name":594,"role":56,"phone":595,"phoneExt":35,"email":596},"Simona Sica","390635503953","simona.sica@unicatt.it",{"facility":598,"status":62,"city":599,"state":35,"zip":600,"country":601,"countryCode":602,"cosmosGeoPoint":603,"geoPoint":607,"contacts":608},"Hospital Universitari Vall d'Hebron","Barcelona","08035","Spain","ES",{"type":69,"coordinates":604},[605,606],2.15899,41.38879,{"lat":606,"lon":605},[609],{"name":610,"role":56,"phone":611,"phoneExt":612,"email":613},"Olga Salamero","34932746100","4894","osalamero@vhio.net",{"facility":615,"status":62,"city":616,"state":35,"zip":617,"country":601,"countryCode":602,"cosmosGeoPoint":618,"geoPoint":622,"contacts":623},"Hospital Universitario Central de Asturias","Oviedo","33011",{"type":69,"coordinates":619},[620,621],-5.84476,43.36029,{"lat":621,"lon":620},[624],{"name":625,"role":56,"phone":626,"phoneExt":35,"email":627},"Teresa Bernal del Castillo","34618753904","Bernaldelcastillo@gmail.com",{"facility":629,"status":62,"city":630,"state":35,"zip":631,"country":601,"countryCode":602,"cosmosGeoPoint":632,"geoPoint":636,"contacts":637},"Hospital Universitario Virgen del Rocío","Seville","41013",{"type":69,"coordinates":633},[634,635],-5.97317,37.38283,{"lat":635,"lon":634},[638],{"name":639,"role":56,"phone":640,"phoneExt":35,"email":641},"Eduardo Rodríguez-Arbolí","34955013277","edurodarb@gmail.com",{"facility":643,"status":62,"city":644,"state":35,"zip":645,"country":601,"countryCode":602,"cosmosGeoPoint":646,"geoPoint":650,"contacts":651},"Hospital Universitari y Politecnic La Fe","Valencia","46026",{"type":69,"coordinates":647},[648,649],-0.37966,39.47391,{"lat":649,"lon":648},[652],{"name":653,"role":56,"phone":654,"phoneExt":35,"email":655},"Pau Montesinos Fernandez","34961244925","montesinos_pau@gva.es",{"type":657,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100516228","phase-1-safety-and-tolerability-of-ziftomenib-combinations-in-patients-with-relapsedrefractory-acute-myeloid-leukemia-100516228",false,"NCT06001788","Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed\u002FRefractory Acute Myeloid Leukemia","Phase 1 Study to Determine the Safety and Tolerability of Ziftomenib Combinations for the Treatment of KMT2A-rearranged or NPM1-mutant Relapsed\u002FRefractory Acute Myeloid Leukemia","Key Inclusion Criteria:\n\n* Has been diagnosed with relapsed\u002Frefractory AML.\n* Has a documented NPM1 mutation or KMT2A rearrangement.\n* Has a documented FLT3 mutation (cA-3 only).\n* Has an Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2.\n* Has adequate hepatic and renal function as defined per protocol.\n* Has an ejection fraction above a protocol defined limit.\n* Participant, or legally authorized representative, must be able to understand and provide written informed consent prior to the first screening procedure.\n* Has agreed to use contraception as defined per protocol.\n\nKey Exclusion Criteria:\n\n* Has a diagnosis of acute promyelocytic leukemia or blast chronic myeloid leukemia.\n* Has clinically active central nervous system leukemia.\n* Has an active and uncontrolled infection.\n* Has a mean corrected QT interval (QTcF) \\> 480ms.\n* Has uncontrolled intercurrent illness, including, but not limited to protocol defined cardiac disease.\n* Has received radiation, chemotherapy, immunotherapy, or any other anticancer therapy including investigational therapy \\\u003C14 days or within 5 drug half-lives prior to the first dose of study intervention.\n* Has had major surgery within 4 weeks prior to the first dose of study intervention.\n* Has received a hematopoietic stem cell transplant (HSCT) and has not previously had adequate recovery per protocol defined criteria.\n* Has active graft-versus-host disease (GvHD) and or on immunosuppressive drugs for the treatment of GvHD\n* Participant is pregnant or lactating.","ALL","18 Years",{"count":668,"type":669},171,"ESTIMATED","INTERVENTIONAL",[672],"PHASE1","The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed\u002Frefractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.",[675,676,677,678,679,680,681,682,683,684,685,686],"AML","AML With Mutated NPM1","Hematologic Malignancy","KMT2Ar","NPM1 Mutation","MLL Rearrangement","Leukemia","Acute Myeloid Leukemia","Leukemia, Myeloid","Leukemia, Myeloid, Acute","Acute Leukemia","Neoplasms by Histologic Type","2026-04-10",{"date":689,"type":690},"2026-04-14","ACTUAL",{"date":692,"type":690},"2024-02-22",{"date":694,"type":669},"2027-08",{"name":5,"class":6},45]