[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054172":3},{"organization":4,"outcomesModule":7,"designInfo":57,"detailedDescription":63,"studyPopulation":56,"armGroups":64,"interventions":88,"overallOfficials":56,"centralContacts":105,"locations":113,"responsibleParty":476,"collaborators":56,"id":478,"slug":56,"hasResults":479,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":56,"eligibilityCriteria":483,"healthyVolunteers":479,"sex":484,"minAge":485,"maxAge":486,"enrollmentInfo":487,"targetDuration":56,"studyType":490,"phases":491,"briefSummary":494,"conditions":495,"keywords":499,"overallStatus":116,"whyStopped":56,"lastUpdateSubmitDate":505,"lastUpdatePostDateStruct":506,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":514},{"fullName":5,"class":6},"Novartis","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":56},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Phase I: Incidence of dose-limiting toxicities (DLTs)","A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications that occurs within the first 28 days of treatment. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.","2 years",{"measure":14,"description":15,"timeFrame":12},"Phase I: Incidence of adverse events (AEs) and serious adverse events (SAEs)","Number of participants with AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.",{"measure":17,"description":18,"timeFrame":12},"Phase I: Number of participants with dose interruptions, reductions and discontinuations","Assessment of tolerability. For patients who do not tolerate the protocol-specified dosing schedule, dose adjustments are permitted in order to allow patients to continue the study treatment.",{"measure":20,"description":21,"timeFrame":22},"Phase II: PFS rate at 6 months per local response evaluation criteria in solid tumors (RECIST) v1.1","Progression Free Survival (PFS) rate at 6 months is defined as the proportion of patients who are alive and progression-free per RECIST v1.1 at 6 months.","6 months",[24,28,31,34,37,40,43,46,49,52,54],{"measure":25,"description":26,"timeFrame":27},"Phase I and II: Area under the plasma concentration-time curve (AUC) of ECI830 and ribociclib","Pharmacokinetic (PK) parameters calculated based on ECI830 and ribociclib plasma concentrations by using non-compartmental methods.","From pre-dose up to 24 hours post-dose in Cycle 1. One cycle=28 days.",{"measure":29,"description":30,"timeFrame":27},"Phase I and II: Maximum observed plasma concentration (Cmax) of ECI830 and ribociclib","PK parameters calculated based on ECI830 and ribociclib plasma concentrations by using non-compartmental methods.",{"measure":32,"description":33,"timeFrame":12},"Phase I and II: Best overall response (BOR) per RECIST v1.1","BOR per RECIST v1.1 is defined as the best overall confirmed response recorded from the start of the treatment until progressive disease (PD), death, start of new therapy, withdrawal of consent or end of study, whatever comes first.",{"measure":35,"description":36,"timeFrame":12},"Phase I and II: Overall response rate (ORR) per RECIST v1.1","ORR per RECIST v1.1 is defined as the proportion of patients with a BOR of Complete response (CR) or Partial response (PR) according to RECIST v1.1 as per local review.",{"measure":38,"description":39,"timeFrame":12},"Phase I and II: Disease control rate (DCR) per RECIST v1.1","DCR per RECIST v1.1 is defined as the proportion of patients with a BOR of CR, PR, or Stable disease (SD) according to RECIST v1.1 as per local review.",{"measure":41,"description":42,"timeFrame":12},"Phase I and II: Clinical benefit rate (CBR) per RECIST v1.1","CBR per RECIST v1.1 is defined as the proportion of patients with a BOR of CR, PR, or an overall lesion response of SD or Non-CR\u002FNon-PD which lasts for at least 24 weeks according to RECIST v1.1 as per local review.",{"measure":44,"description":45,"timeFrame":12},"Phase I and II: Progression Free Survival (PFS) per RECIST v1.1","PFS is defined as the time from the date randomization to the date of the first documented progression or death due to any cause.",{"measure":47,"description":48,"timeFrame":12},"Phase II: Duration of Response (DOR) per RECIST v1.1","DOR per RECIST v1.1 is the time between the first documented response (CR or PR) and the date of progression or death due to any cause.",{"measure":50,"description":51,"timeFrame":12},"Phase II: Overall Survival (OS)","OS is defined as the time between the date of randomization to the date of death due to any cause.",{"measure":53,"description":15,"timeFrame":12},"Phase II: Incidence of adverse events (AEs) and serious adverse events (SAEs)",{"measure":55,"description":18,"timeFrame":12},"Phase II: Number of participants with dose interruptions, reductions and discontinuations",null,{"allocation":58,"interventionModel":59,"interventionModelDescription":56,"primaryPurpose":60,"observationalModel":56,"timePerspective":56,"maskingInfo":61},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":62,"maskingDescription":56,"whoMasked":56},"NONE","This is a first-in-human, open-label, phase I\u002FII, multi-center study consisting of an ECI830 single agent treatment arm in patients with advanced HR+\u002FHER2- breast cancer or other advanced solid tumors harboring CCNE1 amplification or extensive-stage small cell lung cancer (ES-SCLC), and a combination treatment arm of ECI830 with ribociclib and fulvestrant in patients with advanced breast cancer. Single agent escalation may be followed by an expansion part stratified by disease indication. The escalation of the combination arm may continue into a randomized, open label, Phase II with optional dose optimization in advanced breast cancer patients.",[65,71,76,80,83,86],{"label":66,"type":67,"description":68,"interventionNames":69},"ECI830 Single Agent (Arm A)","EXPERIMENTAL","Phase I",[70],"Drug: ECI830",{"label":72,"type":67,"description":68,"interventionNames":73},"Dose Escalation Combination ECI830 + ribociclib + fulvestrant (Arm B)",[70,74,75],"Drug: ribociclib","Drug: fulvestrant",{"label":77,"type":67,"description":78,"interventionNames":79},"Ribociclib in combination with fulvestrant (Arm C)","Phase II",[74,75],{"label":81,"type":67,"description":78,"interventionNames":82},"ECI830 in combination with fulvestrant (Arm D)",[70,75],{"label":84,"type":67,"description":78,"interventionNames":85},"ECI830 in combination with ribociclib and fulvestrant (Arm E)",[70,74,75],{"label":87,"type":67,"description":78,"interventionNames":56},"ECI830 in combination with ribociclib and fulvestrant (Arm F)",[89,94,100],{"type":90,"name":91,"description":92,"armGroupLabels":93,"otherNames":56},"DRUG","ECI830","Experimental",[72,66,81,84],{"type":90,"name":95,"description":96,"armGroupLabels":97,"otherNames":98},"ribociclib","Approved medication",[72,84,77],[99],"Kisqali",{"type":90,"name":101,"description":96,"armGroupLabels":102,"otherNames":103},"fulvestrant",[72,81,84,77],[104],"Faslodex",[106,111],{"name":107,"role":108,"phone":109,"phoneExt":56,"email":110},"Novartis Pharmaceuticals","CONTACT","1-888-669-6682","novartis.email@novartis.com",{"name":107,"role":108,"phone":112,"phoneExt":56,"email":110},"+41613241111",[114,136,153,170,187,202,218,235,252,264,272,283,292,303,307,316,326,334,344,352,363,371,379,389,397,408,416,422,431,440,450,455,465],{"facility":115,"status":116,"city":117,"state":118,"zip":119,"country":120,"countryCode":121,"cosmosGeoPoint":122,"geoPoint":127,"contacts":128},"University of California LA","RECRUITING","Los Angeles","California","90095","United States","US",{"type":123,"coordinates":124},"Point",[125,126],-118.24368,34.05223,{"lat":126,"lon":125},[129,133],{"name":130,"role":108,"phone":131,"phoneExt":56,"email":132},"Rika Galias","+1 310 794 4376","rgalias@mednet.ucla.edu",{"name":134,"role":135,"phone":56,"phoneExt":56,"email":56},"Saeed Sadeghi","PRINCIPAL_INVESTIGATOR",{"facility":137,"status":116,"city":138,"state":139,"zip":140,"country":120,"countryCode":121,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Florida Cancer Specialists","Fort Myers","Florida","33901",{"type":123,"coordinates":142},[143,144],-81.84059,26.62168,{"lat":144,"lon":143},[147,151],{"name":148,"role":108,"phone":149,"phoneExt":56,"email":150},"Sarah Gwirtz","+1 941 377 9993","Sarah.Gwirtz@flcancer.com",{"name":152,"role":135,"phone":56,"phoneExt":56,"email":56},"Manish Patel",{"facility":154,"status":116,"city":155,"state":156,"zip":157,"country":120,"countryCode":121,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Dana Farber Cancer Institute","Boston","Massachusetts","02115",{"type":123,"coordinates":159},[160,161],-71.05977,42.35843,{"lat":161,"lon":160},[164,168],{"name":165,"role":108,"phone":166,"phoneExt":56,"email":167},"Jacob Conway","+1 617 632 5136","jacob_conway@dfci.harvard.edu",{"name":169,"role":135,"phone":56,"phoneExt":56,"email":56},"Antonio Giordano",{"facility":171,"status":116,"city":172,"state":173,"zip":174,"country":120,"countryCode":121,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"WA Uni School Of Med","St Louis","Missouri","63110",{"type":123,"coordinates":176},[177,178],-90.19789,38.62727,{"lat":178,"lon":177},[181,185],{"name":182,"role":108,"phone":183,"phoneExt":56,"email":184},"Mary Halim","+1 314 362 7249","maryh@wustl.edu",{"name":186,"role":135,"phone":56,"phoneExt":56,"email":56},"Cynthia Ma",{"facility":188,"status":116,"city":189,"state":189,"zip":190,"country":120,"countryCode":121,"cosmosGeoPoint":191,"geoPoint":195,"contacts":196},"Memorial Sloan Kettering","New York","10017",{"type":123,"coordinates":192},[193,194],-74.00597,40.71427,{"lat":194,"lon":193},[197,200],{"name":198,"role":108,"phone":56,"phoneExt":56,"email":199},"Josie Anderson","andersj@mskcc.org",{"name":201,"role":135,"phone":56,"phoneExt":56,"email":56},"Komal Jhaveri",{"facility":203,"status":116,"city":204,"state":205,"zip":206,"country":120,"countryCode":121,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"SCRI Oncology Partners","Nashville","Tennessee","37203",{"type":123,"coordinates":208},[209,210],-86.78444,36.16589,{"lat":210,"lon":209},[213,216],{"name":214,"role":108,"phone":56,"phoneExt":56,"email":215},"Kristy Long","kristy.long@SCRI.com",{"name":217,"role":135,"phone":56,"phoneExt":56,"email":56},"Erika Paige Hamilton",{"facility":219,"status":116,"city":220,"state":221,"zip":222,"country":120,"countryCode":121,"cosmosGeoPoint":223,"geoPoint":227,"contacts":228},"MD Anderson Cancer Center Uni of Te","Houston","Texas","77030",{"type":123,"coordinates":224},[225,226],-95.36327,29.76328,{"lat":226,"lon":225},[229,233],{"name":230,"role":108,"phone":231,"phoneExt":56,"email":232},"Ileana Gutierrez","+1 713 792 2848","ilgutierrez@mdanderson.org",{"name":234,"role":135,"phone":56,"phoneExt":56,"email":56},"Timothy Yap",{"facility":236,"status":116,"city":237,"state":238,"zip":239,"country":120,"countryCode":121,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Fred Hutch Cancer Research","Seattle","Washington","98109",{"type":123,"coordinates":241},[242,243],-122.33207,47.60621,{"lat":243,"lon":242},[246,250],{"name":247,"role":108,"phone":248,"phoneExt":56,"email":249},"Ly Tieng Huot","+1 206288 1382","lhuot@fredhutch.org",{"name":251,"role":135,"phone":56,"phoneExt":56,"email":56},"Sara Hurvitz",{"facility":253,"status":116,"city":254,"state":255,"zip":256,"country":257,"countryCode":258,"cosmosGeoPoint":259,"geoPoint":263,"contacts":56},"Novartis Investigative Site","Clayton","Victoria","3168","Australia","AU",{"type":123,"coordinates":260},[261,262],145.11667,-37.91667,{"lat":262,"lon":261},{"facility":253,"status":116,"city":265,"state":255,"zip":266,"country":257,"countryCode":258,"cosmosGeoPoint":267,"geoPoint":271,"contacts":56},"Melbourne","3004",{"type":123,"coordinates":268},[269,270],144.96332,-37.814,{"lat":270,"lon":269},{"facility":253,"status":116,"city":273,"state":274,"zip":275,"country":276,"countryCode":277,"cosmosGeoPoint":278,"geoPoint":282,"contacts":56},"Toronto","Ontario","M5G 2M9","Canada","CA",{"type":123,"coordinates":279},[280,281],-79.39864,43.70643,{"lat":281,"lon":280},{"facility":253,"status":116,"city":284,"state":285,"zip":286,"country":276,"countryCode":277,"cosmosGeoPoint":287,"geoPoint":291,"contacts":56},"Montreal","Quebec","H4A 3J1",{"type":123,"coordinates":288},[289,290],-73.58781,45.50884,{"lat":290,"lon":289},{"facility":253,"status":116,"city":293,"state":294,"zip":295,"country":296,"countryCode":297,"cosmosGeoPoint":298,"geoPoint":302,"contacts":56},"Nanjing","Jiangsu","210029","China","CN",{"type":123,"coordinates":299},[300,301],118.77778,32.06167,{"lat":301,"lon":300},{"facility":253,"status":116,"city":304,"state":305,"zip":306,"country":296,"countryCode":297,"cosmosGeoPoint":56,"geoPoint":56,"contacts":56},"Xian","Shanxi","710061",{"facility":253,"status":116,"city":308,"state":56,"zip":309,"country":310,"countryCode":56,"cosmosGeoPoint":311,"geoPoint":315,"contacts":56},"Brno","656 53","Czechia",{"type":123,"coordinates":312},[313,314],16.60796,49.19522,{"lat":314,"lon":313},{"facility":253,"status":116,"city":317,"state":56,"zip":318,"country":319,"countryCode":320,"cosmosGeoPoint":321,"geoPoint":325,"contacts":56},"Copenhagen","DK-2100","Denmark","DK",{"type":123,"coordinates":322},[323,324],12.56553,55.67594,{"lat":324,"lon":323},{"facility":253,"status":116,"city":327,"state":56,"zip":328,"country":319,"countryCode":320,"cosmosGeoPoint":329,"geoPoint":333,"contacts":56},"Odense C","5000",{"type":123,"coordinates":330},[331,332],10.39538,55.40841,{"lat":332,"lon":331},{"facility":253,"status":116,"city":335,"state":56,"zip":336,"country":337,"countryCode":338,"cosmosGeoPoint":339,"geoPoint":343,"contacts":56},"Bordeaux","33076","France","FR",{"type":123,"coordinates":340},[341,342],-0.58046,44.84124,{"lat":342,"lon":341},{"facility":253,"status":116,"city":345,"state":56,"zip":346,"country":337,"countryCode":338,"cosmosGeoPoint":347,"geoPoint":351,"contacts":56},"Saint-Herblain","44805",{"type":123,"coordinates":348},[349,350],-1.651,47.21154,{"lat":350,"lon":349},{"facility":253,"status":116,"city":353,"state":354,"zip":355,"country":356,"countryCode":357,"cosmosGeoPoint":358,"geoPoint":362,"contacts":56},"Freiburg im Breisgau","Baden-Wurttemberg","79106","Germany","DE",{"type":123,"coordinates":359},[360,361],7.85222,47.9959,{"lat":361,"lon":360},{"facility":253,"status":116,"city":364,"state":56,"zip":365,"country":356,"countryCode":357,"cosmosGeoPoint":366,"geoPoint":370,"contacts":56},"Heidelberg","69120",{"type":123,"coordinates":367},[368,369],8.69079,49.40768,{"lat":369,"lon":368},{"facility":253,"status":116,"city":372,"state":56,"zip":373,"country":356,"countryCode":357,"cosmosGeoPoint":374,"geoPoint":378,"contacts":56},"Ulm","89081",{"type":123,"coordinates":375},[376,377],9.99155,48.39841,{"lat":377,"lon":376},{"facility":253,"status":116,"city":380,"state":56,"zip":381,"country":382,"countryCode":383,"cosmosGeoPoint":384,"geoPoint":388,"contacts":56},"Haifa","3109601","Israel","IL",{"type":123,"coordinates":385},[386,387],34.99928,32.81303,{"lat":387,"lon":386},{"facility":253,"status":116,"city":390,"state":56,"zip":391,"country":382,"countryCode":383,"cosmosGeoPoint":392,"geoPoint":396,"contacts":56},"Tel Aviv","6423906",{"type":123,"coordinates":393},[394,395],34.78057,32.08088,{"lat":395,"lon":394},{"facility":253,"status":116,"city":398,"state":399,"zip":400,"country":401,"countryCode":402,"cosmosGeoPoint":403,"geoPoint":407,"contacts":56},"Modena","MO","41124","Italy","IT",{"type":123,"coordinates":404},[405,406],10.92539,44.64783,{"lat":406,"lon":405},{"facility":253,"status":116,"city":409,"state":56,"zip":410,"country":401,"countryCode":402,"cosmosGeoPoint":411,"geoPoint":415,"contacts":56},"Milan","20141",{"type":123,"coordinates":412},[413,414],12.59836,42.78235,{"lat":414,"lon":413},{"facility":253,"status":116,"city":417,"state":418,"zip":419,"country":420,"countryCode":421,"cosmosGeoPoint":56,"geoPoint":56,"contacts":56},"Chuo Ku","Tokyo","1040045","Japan","JP",{"facility":253,"status":116,"city":423,"state":56,"zip":424,"country":423,"countryCode":425,"cosmosGeoPoint":426,"geoPoint":430,"contacts":56},"Singapore","119074","SG",{"type":123,"coordinates":427},[428,429],103.85007,1.28967,{"lat":429,"lon":428},{"facility":253,"status":116,"city":432,"state":432,"zip":433,"country":434,"countryCode":56,"cosmosGeoPoint":435,"geoPoint":439,"contacts":56},"Seoul","03080","South Korea",{"type":123,"coordinates":436},[437,438],126.9784,37.566,{"lat":438,"lon":437},{"facility":253,"status":116,"city":441,"state":56,"zip":442,"country":443,"countryCode":444,"cosmosGeoPoint":445,"geoPoint":449,"contacts":56},"Barcelona","08035","Spain","ES",{"type":123,"coordinates":446},[447,448],2.15899,41.38879,{"lat":448,"lon":447},{"facility":253,"status":116,"city":441,"state":56,"zip":451,"country":443,"countryCode":444,"cosmosGeoPoint":452,"geoPoint":454,"contacts":56},"08036",{"type":123,"coordinates":453},[447,448],{"lat":448,"lon":447},{"facility":253,"status":116,"city":456,"state":56,"zip":457,"country":458,"countryCode":459,"cosmosGeoPoint":460,"geoPoint":464,"contacts":56},"Tainan","704","Taiwan","TW",{"type":123,"coordinates":461},[462,463],120.21333,22.99083,{"lat":463,"lon":462},{"facility":253,"status":116,"city":466,"state":467,"zip":468,"country":469,"countryCode":470,"cosmosGeoPoint":471,"geoPoint":475,"contacts":56},"London","Oxford","OX3 7LE","United Kingdom","UK",{"type":123,"coordinates":472},[473,474],-0.12574,51.50853,{"lat":474,"lon":473},{"type":477,"investigatorFullName":56,"investigatorTitle":56,"investigatorAffiliation":56,"oldNameTitle":56,"oldOrganization":56},"SPONSOR","100054172",false,"NCT06726148","Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+\u002FHER2- Breast Cancer and in Patients With Other Advanced Solid Tumors","An Open-label, Multi-center, Phase I\u002FII Study of ECI830 as a Single Agent and in Combination With Ribociclib and Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2-negative Breast Cancer and Advanced Solid Tumors","Inclusion Criteria:\n\nAge ≥ 18 years old.\n\nPatients with one of the following indications:\n\nPhase I:\n\nHR+\u002FHER2- aBC with disease progression on or following at least one line of hormone-based therapy in combination with a CDK4\u002F6i and at least one additional line of systemic therapy for metastatic disease.\n\nHistologically and\u002For cytologically confirmed diagnosis of locally advanced or metastatic cancer with a CCNE1 amplification. For dose expansion only: no more than 3 prior lines of therapy for advanced or metastatic disease.\n\nPatients with ES-SCLC and disease progression on or after standard of care (SoC). For dose expansion only: no more than 2 prior lines of therapy for advanced or metastatic disease are allowed.\n\nPhase II:\n\nHR+\u002FHER2- aBC with disease progression on an aromatase inhibitor or tamoxifen in combination with a CDK4\u002F6 inhibitor for unresectable\u002Fmetastatic disease with no more than 2 lines of endocrine therapy.\n\nMeasurable disease as determined by RECIST v1.1.\n\nBC only: If no measurable disease is present, then at least one predominantly lytic bone lesion must be present that can be accurately assessed at baseline and is suitable for repeated assessment.\n\nExclusion Criteria:\n\nPrevious treatment with a CDK2 inhibitor at any time.\n\nPatients with inadequate bone marrow and\u002For organ functions with out-of-range laboratory values.\n\nClinically significant, uncontrolled heart disease and\u002For cardiac repolarization abnormality including MI, CABG, long QT syndrome, or risk factors for TdP.\n\nPresence of symptomatic CNS metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.\n\nFor the combination treatment:\n\nPatients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.\n\nPatients who could not tolerate the prescribed dose of ribociclib during a previous course of treatment, requiring dose reduction or permanent discontinuation due to adverse events.\n\nFor patients with BC: Patient is concurrently using hormone replacement therapy.\n\nWOCBP who are unwilling to use highly effective contraception methods, pregnant or nursing women.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","18 Years","100 Years",{"count":488,"type":489},280,"ESTIMATED","INTERVENTIONAL",[492,493],"PHASE1","PHASE2","Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization\u002Frecommended dose for future studies.\n\nPhase II: Assess the anti-tumor activity of ECI830 in combination with ribociclib and fulvestrant in patients with hormone receptor-positive\u002Fhuman epidermal growth factor receptor 2-negative (HR+\u002FHER2-) advanced breast cancer.",[496,497,498],"Advanced HR+\u002FHER2- Breast Cancer","Advanced CCNE1-amplified Solid Tumors","Extensive-stage Small Cell Lung Cancer",[91,500,501,502,503,504],"Ribociclib","Fulvestrant","Breast cancer","CCNE1 amplification","Small cell lung cancer","2026-07-09",{"date":507,"type":508},"2026-07-13","ACTUAL",{"date":510,"type":508},"2025-04-03",{"date":512,"type":489},"2028-09-25",{"name":107,"class":6},33]