[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054019":3},{"organization":4,"outcomesModule":7,"designInfo":117,"detailedDescription":123,"studyPopulation":11,"armGroups":124,"interventions":145,"overallOfficials":167,"centralContacts":171,"locations":176,"responsibleParty":612,"collaborators":11,"id":614,"slug":11,"hasResults":615,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":11,"eligibilityCriteria":619,"healthyVolunteers":615,"sex":620,"minAge":621,"maxAge":11,"enrollmentInfo":622,"targetDuration":11,"studyType":625,"phases":626,"briefSummary":629,"conditions":630,"keywords":634,"overallStatus":193,"whyStopped":11,"lastUpdateSubmitDate":638,"lastUpdatePostDateStruct":639,"startDateStruct":642,"completionDateStruct":644,"leadSponsor":646,"locationsCount":647},{"fullName":5,"class":6},"BeOne Medicines","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":35,"otherOutcomes":11},[9,13,16,19,22,25,27,30,33],{"measure":10,"description":11,"timeFrame":12},"Part 1 And 2: Number Of Participants Experiencing Dose-limiting Toxicities (DLTs)",null,"Cycle 1 (Up to 28 days for non-hematologic DLTs and up to 42 days for hematologic DLTs)",{"measure":14,"description":11,"timeFrame":15},"Part 1 And 2: Number Of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)","Approximately 24 months",{"measure":17,"description":18,"timeFrame":15},"Part 3 AML Cohort: Complete Remission (CR) Plus CR With Partial Hematologic Recovery (CRh) Rate","CR plus CRh will be defined as the percentage of participants whose best overall response (BOR) is CR plus CRh. BOR will be defined as the best response recorded from the first dose of study drug until data cut or the initiation of new anticancer treatment.",{"measure":20,"description":21,"timeFrame":15},"Part 3 MDS Cohort: Modified Overall Response (mOR) Rate","The mOR will be defined as the percentage of participants whose BOR is achieving CR, marrow complete remission (mCR), or partial remission (PR) at any time point during the study for myelodysplastic\u002Fmyeloproliferative neoplasm (MDS\u002FMPN).",{"measure":23,"description":11,"timeFrame":24},"Part 3 AML Cohort (DDI Sub-cohort): Area Under Plasma Concentration-time Curve (AUC) from time 0 to the last quantifiable timepoint (t) (AUC0-t) Of BGB-11417 When Administered Alone and when Co-administered With Posaconazole","Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 2, 4, 6, 8, and 24 hours postdose)",{"measure":26,"description":11,"timeFrame":24},"Part 3 AML Cohort (DDI Sub-cohort): Maximum Observed Plasma Concentration (Cmax) Of BGB-11417 When Administered Alone and When Co-administered With Posaconazole",{"measure":28,"description":11,"timeFrame":29},"Part 3 AML Cohort (DDI Sub-cohort): Area Under Plasma Concentration-time Curve (AUC) from time 0 to infinity (AUC0-infinity) Of BGB-11417 When Administered Alone and When Co-administered With Posaconazole","Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, , 4, 6, 8, and 24 hours postdose)",{"measure":31,"description":11,"timeFrame":32},"Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number Of Participants Experiencing DLTs","Cycle 2",{"measure":34,"description":11,"timeFrame":15},"Part 3 AML and MDS Cohorts (Treated with Monotherapy): Number of Participants Experiencing TEAEs",[36,38,40,43,45,47,49,51,53,56,58,60,62,64,67,70,73,76,79,82,85,88,91,94,97,100,103,106,109,112,115],{"measure":37,"description":11,"timeFrame":15},"Parts 1 And 2 AML Cohort: Complete remission (CR) + Morphologic CR With Partial Hematologic Recovery (CRh)",{"measure":39,"description":11,"timeFrame":15},"Parts 1 And 2 MDS Cohort: mOR Rate",{"measure":41,"description":11,"timeFrame":42},"Parts 1 And 2: Cmax Of Azacitidine When Coadministered With BGB-11417","Day 0 and 4 (Cycle 1) predose and at multiple time points up to 4 hours postdose",{"measure":44,"description":11,"timeFrame":42},"Parts 1 And 2: Terminal Half-life (t1\u002F2) Of Azacitidine When Coadministered With BGB-11417",{"measure":46,"description":11,"timeFrame":42},"Parts 1 And 2: AUC From Time Zero To Time t (AUC0-t) Of Azacitidine When Coadministered With BGB-11417",{"measure":48,"description":11,"timeFrame":42},"Parts 1 And 2: AUC From Time Zero To Infinity (AUC0-inf) Of Azacitidine When Coadministered With BGB-11417",{"measure":50,"description":11,"timeFrame":42},"Parts 1 And 2: Apparent Total Clearance Of Azacitidine From Plasma (CL\u002FF) When Coadministered With BGB-11417",{"measure":52,"description":11,"timeFrame":42},"Parts 1 And 2: Apparent Volume Of Distribution (Vz\u002FF) Of Azacitidine When Coadministered With BGB-11417",{"measure":54,"description":11,"timeFrame":55},"Parts 1 And 2: Steady-state AUC From Time Zero To Time Of Last Measurable Concentration (AUClast,ss) Of BGB-11417 When Coadministered With Azacitidine","Day 1-4 and 28 (Cycle 1) Day 5 (Cycle 2) predose and at multiple time points up to 8 hours postdose",{"measure":57,"description":11,"timeFrame":55},"Parts 1 And 2: Steady-state Cmax (Cmax,ss) Of BGB-11417 When Coadministered With Azacitidine",{"measure":59,"description":11,"timeFrame":55},"Parts 1 And 2: Steady-state Trough Plasma Concentration (Ctrough,ss) Of BGB-11417 When Coadministered With Azacitidine",{"measure":61,"description":11,"timeFrame":55},"Parts 1 And 2: Steady-state Time To Maximum Observed Plasma Concentration (tmax,ss) Of BGB-11417 When Coadministered With Azacitidine",{"measure":63,"description":11,"timeFrame":15},"Part 3: Number Of Participants Experiencing TEAEs",{"measure":65,"description":66,"timeFrame":15},"Part 3: Complete Response Rate","CR will be defined as the percentage of participants whose BOR is CR. BOR will be defined as the best response recorded from the first dose of study drug until data cut or the initiation of new anticancer treatment.",{"measure":68,"description":69,"timeFrame":15},"Part 3 AML Cohort: CR With Incomplete Hematologic Recovery (CRi) Rate","CRi will be defined as the percentage of participants whose BOR is CRi.",{"measure":71,"description":72,"timeFrame":15},"Part 3 AML Cohort: Overall Response Rate (ORR)","The ORR will include participants whose BOR include CR, CRi, PR, and morphologic leukemia-free state.",{"measure":74,"description":75,"timeFrame":15},"Part 3 AML Cohort: Duration Of Response (DOR)","DOR will be defined as the time from the first response to disease progression documented after treatment initiation or death, whichever occurs first. DOR will include CR, CR plus CRi, overall response (OR), and CR plus CRh.",{"measure":77,"description":78,"timeFrame":15},"Part 3 AML Cohort: Time To Response (TTR)","TTR will be defined as the time from treatment initiation to the first documented response and will include CR, CR plus CRi, OR, and CR plus CRh.",{"measure":80,"description":81,"timeFrame":15},"Part 3 Event-free Survival (EFS)","EFS will be defined as the time from treatment initiation to disease progression, treatment failure, relapse (hematologic relapse for AML) for those who have treatment success, or death due to any cause, whichever happens first.",{"measure":83,"description":84,"timeFrame":15},"Part 3 Overall Survival (OS)","OS will be defined as the time from treatment initiation to death. OS will be analyzed using the same methods as the EFS analysis except for the censoring rules.",{"measure":86,"description":87,"timeFrame":15},"Part 3 AML Cohort: Number of Participants with Transfusion Independence","Transfusion independence will be defined as the proportion of participants whose BOR is transfusion independence. Transfusion independence will need to last for at least 56 consecutive days postbaseline.",{"measure":89,"description":90,"timeFrame":15},"Part 3 MDS Cohort: Number Of Participants With Hematological Improvement-erythroid (HI-E)","The proportion of participants whose BOR is HI-E",{"measure":92,"description":93,"timeFrame":15},"Part 3 MDS Cohort: Proportion Of Participants With Hematological Improvement-platelet (HI-P)","The proportion of participants whose BOR is HI-P",{"measure":95,"description":96,"timeFrame":15},"Part 3 MDS Cohort: Proportion Of Participants With Hematological Improvement-neutrophil (HI-N)","The proportion of participants whose BOR is HI-N will be reported.",{"measure":98,"description":99,"timeFrame":15},"Part 3 MDS Cohort: Number of participants with Transfusion Independence","Transfusion independence will be defined as the percentage of participants whose BOR is transfusion independence. Transfusion independence will need to last for at least 56 consecutive days postbaseline.",{"measure":101,"description":11,"timeFrame":102},"Part 3: Ctrough,ss Of BGB-11417 When Coadministered With Azacitidine","Cycle 1 Day 1 and Cycle 2 Day 5 (predose and 4 and 6 hours postdose)",{"measure":104,"description":105,"timeFrame":15},"Part 3 MDS cohort: Partial Hematologic Recovery CRh","Percentage of participants with partial hematologic recovery will be reported",{"measure":107,"description":108,"timeFrame":15},"Part 3 AML (Treated with Monotherapy): Complete Response + Morphologic complete Remission with Partial Hematologic Recovery","Percentage of participants with Complete Response + Morphologic complete Remission with Partial Hematologic Recovery will be reported.",{"measure":110,"description":11,"timeFrame":111},"Part 3 AML (Treated with Monotherapy): Steady State trough plasma concentration of BGB-11417","Cycle 2 Day 12 and Cycle 2 Day 20 (predose and 1, 4, 6, 8, and 24 hours postdose)",{"measure":113,"description":114,"timeFrame":15},"Part 3 MDS (Treated with Monotherapy): Modified Overall Response","Percentage of participants with modified overall response including CR, marrow CR (mCR) or partial remission (PR)",{"measure":116,"description":11,"timeFrame":111},"Part 3 MDS (Treated with Monotherapy): Steady State trough plasma concentration of BGB-11417",{"allocation":118,"interventionModel":119,"interventionModelDescription":11,"primaryPurpose":120,"observationalModel":11,"timePerspective":11,"maskingInfo":121},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":122,"maskingDescription":11,"whoMasked":11},"NONE","Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.",[125,132,136,141],{"label":126,"type":127,"description":128,"interventionNames":129},"Parts 1 and 2: AML Cohorts","EXPERIMENTAL","Participants with AML will receive BGB-11417 and azacitidine on a 28-day cycle.",[130,131],"Drug: BGB-11417","Drug: Azacitidine",{"label":133,"type":127,"description":134,"interventionNames":135},"Parts 1 and 2: MDS Cohorts","Participants with MDS will receive BGB-11417 and azacitidine on a 28-day cycle.",[131,130],{"label":137,"type":127,"description":138,"interventionNames":139},"Part 3: AML and MDS Cohorts","Participants with AML and MDS will receive BGB-11417 and azacitidine on a 28-day cycle. A subset of the participants will receive a modified second cycle of treatment to explore drug-drug interactions (DDI) with posaconazole.",[130,131,140],"Drug: Posaconazole",{"label":142,"type":127,"description":143,"interventionNames":144},"Part 3: AML and MDS Cohort","Participants with MDS and R\u002FR AML (China only) will receive BGB-11417 on a 28-day cycle.",[130],[146,153,157,161,164],{"type":147,"name":148,"description":149,"armGroupLabels":150,"otherNames":151},"DRUG","BGB-11417","Oral administration for 10, 21, 14 or 28 days on a 28-day cycle.",[137,126],[152],"Sonrotoclax",{"type":147,"name":154,"description":155,"armGroupLabels":156,"otherNames":11},"Azacitidine","Intravenous or subcutaneous administration for 7 days.",[137,126,133],{"type":147,"name":158,"description":159,"armGroupLabels":160,"otherNames":11},"Posaconazole","Oral administration for 8 days on second cycle only.",[137],{"type":147,"name":148,"description":162,"armGroupLabels":163,"otherNames":11},"Oral 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States","US",{"type":186,"coordinates":187},"Point",[188,189],-117.97729,34.13945,{"lat":189,"lon":188},{"facility":192,"status":193,"city":194,"state":195,"zip":196,"country":183,"countryCode":184,"cosmosGeoPoint":197,"geoPoint":201,"contacts":11},"Tampa General Hospital","RECRUITING","Tampa","Florida","33606-3571",{"type":186,"coordinates":198},[199,200],-82.45843,27.94752,{"lat":200,"lon":199},{"facility":203,"status":193,"city":204,"state":205,"zip":206,"country":183,"countryCode":184,"cosmosGeoPoint":207,"geoPoint":211,"contacts":11},"Upmc Hillman Cancer Center(Univ of Pittsburgh)","Pittsburgh","Pennsylvania","15232-1309",{"type":186,"coordinates":208},[209,210],-79.99589,40.44062,{"lat":210,"lon":209},{"facility":213,"status":193,"city":214,"state":215,"zip":216,"country":183,"countryCode":184,"cosmosGeoPoint":217,"geoPoint":221,"contacts":11},"Md Anderson Cancer Center","Houston","Texas","77030-3907",{"type":186,"coordinates":218},[219,220],-95.36327,29.76328,{"lat":220,"lon":219},{"facility":223,"status":193,"city":224,"state":225,"zip":226,"country":183,"countryCode":184,"cosmosGeoPoint":227,"geoPoint":231,"contacts":11},"Medical College of Wisconsin","Milwaukee","Wisconsin","53226-3522",{"type":186,"coordinates":228},[229,230],-87.90647,43.0389,{"lat":230,"lon":229},{"facility":233,"status":193,"city":234,"state":235,"zip":236,"country":237,"countryCode":238,"cosmosGeoPoint":239,"geoPoint":243,"contacts":11},"Concord Repatriation General Hospital","Concord","New South Wales","NSW 2139","Australia","AU",{"type":186,"coordinates":240},[241,242],151.10381,-33.84722,{"lat":242,"lon":241},{"facility":245,"status":193,"city":246,"state":235,"zip":247,"country":237,"countryCode":238,"cosmosGeoPoint":248,"geoPoint":252,"contacts":11},"St George Hospital","Kogarah","NSW 2217",{"type":186,"coordinates":249},[250,251],151.13564,-33.9681,{"lat":251,"lon":250},{"facility":254,"status":193,"city":255,"state":235,"zip":256,"country":237,"countryCode":238,"cosmosGeoPoint":257,"geoPoint":261,"contacts":11},"Orange Health Hospital","Orange","NSW 2800",{"type":186,"coordinates":258},[259,260],149.10018,-33.28397,{"lat":260,"lon":259},{"facility":263,"status":193,"city":264,"state":265,"zip":266,"country":237,"countryCode":238,"cosmosGeoPoint":267,"geoPoint":271,"contacts":11},"Gold Coast University Hospital","Southport","Queensland","QLD 4215",{"type":186,"coordinates":268},[269,270],153.39796,-27.96724,{"lat":270,"lon":269},{"facility":273,"status":193,"city":274,"state":275,"zip":276,"country":237,"countryCode":238,"cosmosGeoPoint":277,"geoPoint":281,"contacts":11},"Monash Health","Clayton","Victoria","VIC 3168",{"type":186,"coordinates":278},[279,280],145.11667,-37.91667,{"lat":280,"lon":279},{"facility":283,"status":193,"city":284,"state":275,"zip":285,"country":237,"countryCode":238,"cosmosGeoPoint":286,"geoPoint":290,"contacts":11},"St Vincents Hospital Melbourne","Fitzroy","VIC 3065",{"type":186,"coordinates":287},[288,289],144.97833,-37.79839,{"lat":289,"lon":288},{"facility":292,"status":193,"city":293,"state":275,"zip":294,"country":237,"countryCode":238,"cosmosGeoPoint":295,"geoPoint":299,"contacts":11},"Austin Health","Heidelberg","VIC 3084",{"type":186,"coordinates":296},[297,298],145.06667,-37.75,{"lat":298,"lon":297},{"facility":301,"status":193,"city":302,"state":275,"zip":303,"country":237,"countryCode":238,"cosmosGeoPoint":304,"geoPoint":308,"contacts":11},"The Alfred Hospital","Melbourne","VIC 3004",{"type":186,"coordinates":305},[306,307],144.96332,-37.814,{"lat":307,"lon":306},{"facility":310,"status":193,"city":311,"state":312,"zip":313,"country":237,"countryCode":238,"cosmosGeoPoint":314,"geoPoint":318,"contacts":11},"Fiona Stanley Hospital","Murdoch","Western Australia","WA 6150",{"type":186,"coordinates":315},[316,317],115.83757,-32.06987,{"lat":317,"lon":316},{"facility":320,"status":193,"city":321,"state":312,"zip":322,"country":237,"countryCode":238,"cosmosGeoPoint":323,"geoPoint":327,"contacts":11},"Linear Clinical Research","Nedlands","WA 6009",{"type":186,"coordinates":324},[325,326],115.8073,-31.98184,{"lat":326,"lon":325},{"facility":329,"status":193,"city":321,"state":312,"zip":322,"country":237,"countryCode":238,"cosmosGeoPoint":330,"geoPoint":332,"contacts":11},"One Clinical Research",{"type":186,"coordinates":331},[325,326],{"lat":326,"lon":325},{"facility":334,"status":193,"city":335,"state":336,"zip":337,"country":338,"countryCode":339,"cosmosGeoPoint":340,"geoPoint":344,"contacts":11},"Peking University Peoples Hospital","Beijing","Beijing Municipality","100044","China","CN",{"type":186,"coordinates":341},[342,343],116.39723,39.9075,{"lat":343,"lon":342},{"facility":346,"status":193,"city":347,"state":348,"zip":349,"country":338,"countryCode":339,"cosmosGeoPoint":350,"geoPoint":354,"contacts":11},"The First Hospital of Lanzhou University","Lanzhou","Gansu","730000",{"type":186,"coordinates":351},[352,353],103.83987,36.05701,{"lat":353,"lon":352},{"facility":356,"status":193,"city":357,"state":358,"zip":359,"country":338,"countryCode":339,"cosmosGeoPoint":360,"geoPoint":364,"contacts":11},"Guangdong Provincial Peoples Hospital","Guangzhou","Guangdong","510080",{"type":186,"coordinates":361},[362,363],113.25,23.11667,{"lat":363,"lon":362},{"facility":366,"status":193,"city":357,"state":358,"zip":367,"country":338,"countryCode":339,"cosmosGeoPoint":368,"geoPoint":370,"contacts":11},"Nanfang Hospital, Southern Medical University","510515",{"type":186,"coordinates":369},[362,363],{"lat":363,"lon":362},{"facility":372,"status":373,"city":374,"state":358,"zip":375,"country":338,"countryCode":339,"cosmosGeoPoint":376,"geoPoint":380,"contacts":11},"The Second Peoples Hospital of Shenzhen","COMPLETED","Shenzhen","518037",{"type":186,"coordinates":377},[378,379],114.0683,22.54554,{"lat":379,"lon":378},{"facility":382,"status":193,"city":383,"state":384,"zip":385,"country":338,"countryCode":339,"cosmosGeoPoint":386,"geoPoint":390,"contacts":11},"Henan Cancer Hospital","Zhengzhou","Henan","450000",{"type":186,"coordinates":387},[388,389],113.64861,34.75778,{"lat":389,"lon":388},{"facility":392,"status":193,"city":393,"state":394,"zip":395,"country":338,"countryCode":339,"cosmosGeoPoint":396,"geoPoint":400,"contacts":11},"Union Hospital of Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei","430022",{"type":186,"coordinates":397},[398,399],114.26667,30.58333,{"lat":399,"lon":398},{"facility":402,"status":193,"city":403,"state":404,"zip":405,"country":338,"countryCode":339,"cosmosGeoPoint":406,"geoPoint":410,"contacts":11},"The First Affiliated Hospital of Soochow University","Suzhou","Jiangsu","215006",{"type":186,"coordinates":407},[408,409],120.59538,31.30408,{"lat":409,"lon":408},{"facility":412,"status":193,"city":413,"state":414,"zip":415,"country":338,"countryCode":339,"cosmosGeoPoint":416,"geoPoint":420,"contacts":11},"The First Affiliated Hospital of Nanchang University Branch Donghu","Nanchang","Jiangxi","330006",{"type":186,"coordinates":417},[418,419],115.85306,28.68396,{"lat":419,"lon":418},{"facility":422,"status":193,"city":423,"state":424,"zip":425,"country":338,"countryCode":339,"cosmosGeoPoint":426,"geoPoint":430,"contacts":11},"West China Hospital, Sichuan University","Chengdu","Sichuan","610041",{"type":186,"coordinates":427},[428,429],104.06667,30.66667,{"lat":429,"lon":428},{"facility":432,"status":373,"city":433,"state":434,"zip":435,"country":338,"countryCode":339,"cosmosGeoPoint":436,"geoPoint":440,"contacts":11},"Tianjin Medical University Cancer Institute and Hospital","Tianjin","Tianjin Municipality","300060",{"type":186,"coordinates":437},[438,439],117.17667,39.14222,{"lat":439,"lon":438},{"facility":442,"status":193,"city":443,"state":444,"zip":445,"country":338,"countryCode":339,"cosmosGeoPoint":446,"geoPoint":450,"contacts":11},"The First Affiliated Hospital, Zhejiang University School of Medicine","Hangzhou","Zhejiang","310003",{"type":186,"coordinates":447},[448,449],120.16142,30.29365,{"lat":449,"lon":448},{"facility":452,"status":193,"city":453,"state":11,"zip":454,"country":455,"countryCode":456,"cosmosGeoPoint":457,"geoPoint":461,"contacts":11},"Hopital Claude Huriez Chu Lille","Lille","59000","France","FR",{"type":186,"coordinates":458},[459,460],3.05512,50.63391,{"lat":460,"lon":459},{"facility":463,"status":193,"city":464,"state":11,"zip":465,"country":455,"countryCode":456,"cosmosGeoPoint":466,"geoPoint":470,"contacts":11},"Hopital Larchet","Nice","06200",{"type":186,"coordinates":467},[468,469],7.26608,43.70313,{"lat":469,"lon":468},{"facility":472,"status":193,"city":473,"state":11,"zip":474,"country":455,"countryCode":456,"cosmosGeoPoint":475,"geoPoint":479,"contacts":11},"Hopital Saint Louis","Paris","75010",{"type":186,"coordinates":476},[477,478],2.3488,48.85341,{"lat":478,"lon":477},{"facility":481,"status":193,"city":482,"state":11,"zip":483,"country":484,"countryCode":485,"cosmosGeoPoint":486,"geoPoint":490,"contacts":11},"Universitaetsklinikum Leipzig Aor","Leipzig","04103","Germany","DE",{"type":186,"coordinates":487},[488,489],12.37129,51.33962,{"lat":489,"lon":488},{"facility":492,"status":193,"city":493,"state":11,"zip":494,"country":484,"countryCode":485,"cosmosGeoPoint":495,"geoPoint":499,"contacts":11},"Universitaetsklinikum Ulm","Ulm","89081",{"type":186,"coordinates":496},[497,498],9.99155,48.39841,{"lat":498,"lon":497},{"facility":501,"status":193,"city":502,"state":11,"zip":503,"country":504,"countryCode":505,"cosmosGeoPoint":506,"geoPoint":510,"contacts":11},"Policlinico Sorsola Malpighi, Aou Di Bologna","Bologna","40138","Italy","IT",{"type":186,"coordinates":507},[508,509],11.33875,44.49381,{"lat":509,"lon":508},{"facility":512,"status":193,"city":513,"state":11,"zip":514,"country":504,"countryCode":505,"cosmosGeoPoint":515,"geoPoint":519,"contacts":11},"Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst","Meldola","47014",{"type":186,"coordinates":516},[517,518],12.0626,44.12775,{"lat":518,"lon":517},{"facility":521,"status":193,"city":522,"state":11,"zip":523,"country":504,"countryCode":505,"cosmosGeoPoint":524,"geoPoint":528,"contacts":11},"Niguarda Cancer Center Division of Hematology","Milan","20162",{"type":186,"coordinates":525},[526,527],12.59836,42.78235,{"lat":527,"lon":526},{"facility":530,"status":193,"city":531,"state":11,"zip":532,"country":533,"countryCode":534,"cosmosGeoPoint":535,"geoPoint":539,"contacts":11},"North Shore Hospital","Auckland","0622","New Zealand","NZ",{"type":186,"coordinates":536},[537,538],174.76349,-36.84853,{"lat":538,"lon":537},{"facility":541,"status":193,"city":542,"state":11,"zip":543,"country":533,"countryCode":534,"cosmosGeoPoint":544,"geoPoint":548,"contacts":11},"Wellington Regional Hospital (Ccdhb)","Wellington","6021",{"type":186,"coordinates":545},[546,547],174.77557,-41.28664,{"lat":547,"lon":546},{"facility":550,"status":193,"city":551,"state":552,"zip":553,"country":554,"countryCode":11,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Samsung Medical Center","GangnamGu","Seoul Teugbyeolsi","06351","South Korea",{"facility":556,"status":193,"city":557,"state":552,"zip":558,"country":554,"countryCode":11,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"Severance Hospital Yonsei University Health System","SeodaemunGu","03722",{"facility":560,"status":193,"city":561,"state":11,"zip":562,"country":563,"countryCode":564,"cosmosGeoPoint":565,"geoPoint":569,"contacts":11},"Hospital de La Santa Creu I Sant Pau","Barcelona","08041","Spain","ES",{"type":186,"coordinates":566},[567,568],2.15899,41.38879,{"lat":568,"lon":567},{"facility":571,"status":193,"city":572,"state":11,"zip":573,"country":563,"countryCode":564,"cosmosGeoPoint":574,"geoPoint":578,"contacts":11},"Hospital Universitario de Salamanca","Salamanca","37007",{"type":186,"coordinates":575},[576,577],-5.66388,40.96882,{"lat":577,"lon":576},{"facility":580,"status":193,"city":581,"state":11,"zip":582,"country":563,"countryCode":564,"cosmosGeoPoint":583,"geoPoint":587,"contacts":11},"Hospital Universitario Virgen Del Rocio","Seville","41013",{"type":186,"coordinates":584},[585,586],-5.97317,37.38283,{"lat":586,"lon":585},{"facility":589,"status":193,"city":590,"state":11,"zip":591,"country":563,"countryCode":564,"cosmosGeoPoint":592,"geoPoint":596,"contacts":11},"Hospital Universitari I Politecnic La Fe","Valencia","46026",{"type":186,"coordinates":593},[594,595],-0.37966,39.47391,{"lat":595,"lon":594},{"facility":598,"status":193,"city":599,"state":11,"zip":600,"country":601,"countryCode":602,"cosmosGeoPoint":603,"geoPoint":607,"contacts":11},"Edinburgh Cancer Centre","Edinburgh","EH4 2XU","United Kingdom","UK",{"type":186,"coordinates":604},[605,606],-3.19648,55.95206,{"lat":606,"lon":605},{"facility":609,"status":193,"city":610,"state":11,"zip":611,"country":601,"countryCode":602,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"The Christie Hospital","Greater Manchester","M20 4BX",{"type":613,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100054019",false,"NCT04771130","A Study of BGB-11417 in Participants With Myeloid Malignancies","A Phase 1b\u002F2, Open-Label, Dose Finding, and Expansion Study of the Bcl-2 Inhibitor BGB-11417 in Patients With Myeloid Malignancies","Key Inclusion Criteria:\n\n1. Confirmed diagnosis of one of the following by 2016 World Health Organization criteria:\n\n   * AML, nonacute promyelocytic leukemia\n   * MDS\n   * MDS\u002FMPN\n2. Eastern Cooperative Oncology Group performance status of 0 to 2.\n3. Adequate organ function defined as:\n\n   * Creatinine clearance ≥ 50 milliliters\u002Fminute (mL\u002Fmin) (or between 30 and 49 mL\u002Fmin in unfit AML cohort)\n   * Adequate liver function\n4. Life expectancy of \\> 12 weeks.\n5. Ability to comply with the requirements of the study.\n\nKey Exclusion Criteria:\n\n1. A diagnosis of acute promyelocytic leukemia.\n2. History of prior malignancy, with the exception of either a history of MDS or MDS\u002FMPN that has transformed to AML, or other prior malignancy that was treated with a full curative intent and no evidence of recurrence within the past 2 years (eg, localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer)\n3. Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.\n4. Prior therapy with a B-cell lymphoma-2 inhibitor\n5. Known central nervous system involvement by leukemia.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.","ALL","18 Years",{"count":623,"type":624},260,"ESTIMATED","INTERVENTIONAL",[627,628],"PHASE1","PHASE2","The study will determine the safety, tolerability, recommended Phase 2 dose (RP2D) and preliminary efficacy of BGB-11417 as monotherapy and in combination with azacitidine in participants with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)or MDS\u002Fmyeloproliferative neoplasm (MPN) .",[631,632,633],"Acute Myeloid Leukemia","Myelodysplastic Syndromes","Myelodysplastic\u002FMyeloproliferative Neoplasm",[148,154,158,635,636,637],"AML","MDS","MDS\u002FMPN","2026-07-10",{"date":640,"type":641},"2026-07-13","ACTUAL",{"date":643,"type":641},"2021-05-24",{"date":645,"type":624},"2028-02-08",{"name":5,"class":6},46]