[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460813":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":37,"centralContacts":45,"locations":54,"responsibleParty":236,"collaborators":37,"id":238,"slug":37,"hasResults":239,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":37,"eligibilityCriteria":243,"healthyVolunteers":239,"sex":244,"minAge":245,"maxAge":37,"enrollmentInfo":246,"targetDuration":37,"studyType":249,"phases":250,"briefSummary":253,"conditions":254,"keywords":259,"overallStatus":57,"whyStopped":37,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":269},{"fullName":5,"class":6},"Telios Pharma, Inc.","INDUSTRY",[8,15,19,23,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1b - Dose Level 1","EXPERIMENTAL","150 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib.",[13,14],"Drug: TL-895","Drug: Ruxolitinib",{"label":16,"type":10,"description":17,"interventionNames":18},"Phase 1b - Dose Level 2","300 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Phase 1b - Dose Level 3","450 mg of TL-895 will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle combined with the subject's pre-study stable dose of ruxolitinib.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Phase 2 - Cohort 1 JAKi treatment-naïve MF","The RP2D of TL-895 as determined in Phase 1b will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.\n\nThe dose of ruxolitinib will be based on the subject's baseline platelet count.",[13,14],{"label":28,"type":10,"description":29,"interventionNames":30},"Phase 2 - Cohort 2 suboptimal response to Ruxolitinib","The RP2D of TL-895 as determined in Phase 1b will be administered orally, twice daily (BID) continuously starting on Day 1 in a 28-day cycle.\n\nThe dose schedule will be the stable ruxolitinib dose schedule as the subject is currently taking prior to entry into the study.",[13,14],[32,38],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","TL-895","TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.",[9,16,20,24,28],null,{"type":33,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Ruxolitinib","Ruxolitinib is an FDA-approved janus kinase inhibitor anticancer drug taken by mouth.",[9,16,20,24,28],[43,44],"Jakafi","Jakavi",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":37,"email":50},"John Mei","CONTACT","650-542-0136","jmei@teliospharma.com",{"name":52,"role":48,"phone":37,"phoneExt":37,"email":53},"Nikki Stuart","nzona@teliospharma.com",[55,68,78,87,97,107,116,125,134,143,153,161,171,180,189,199,209,218,227],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":37},"University of Alabama at Birmingham","RECRUITING","Birmingham","Alabama","35294","United States",{"type":63,"coordinates":64},"Point",[65,66],-86.80249,33.52066,{"lat":66,"lon":65},{"facility":69,"status":57,"city":70,"state":71,"zip":72,"country":61,"cosmosGeoPoint":73,"geoPoint":77,"contacts":37},"Gabrail Cancer Center","Canton","Ohio","44718",{"type":63,"coordinates":74},[75,76],-81.37845,40.79895,{"lat":76,"lon":75},{"facility":79,"status":57,"city":80,"state":71,"zip":81,"country":61,"cosmosGeoPoint":82,"geoPoint":86,"contacts":37},"University of Cincinnati (UC)","Cincinnati","45267",{"type":63,"coordinates":83},[84,85],-84.51439,39.12711,{"lat":85,"lon":84},{"facility":88,"status":57,"city":89,"state":90,"zip":91,"country":61,"cosmosGeoPoint":92,"geoPoint":96,"contacts":37},"The University of Texas MD Anderson Cancer Center","Houston","Texas","77030",{"type":63,"coordinates":93},[94,95],-95.36327,29.76328,{"lat":95,"lon":94},{"facility":98,"status":57,"city":99,"state":37,"zip":100,"country":101,"cosmosGeoPoint":102,"geoPoint":106,"contacts":37},"CHU Angers","Angers","49100","France",{"type":63,"coordinates":103},[104,105],-0.55202,47.47156,{"lat":105,"lon":104},{"facility":108,"status":57,"city":109,"state":37,"zip":110,"country":101,"cosmosGeoPoint":111,"geoPoint":115,"contacts":37},"AP-HM - Hôpital de la Timone","Marseille","13005",{"type":63,"coordinates":112},[113,114],5.38107,43.29695,{"lat":114,"lon":113},{"facility":117,"status":57,"city":118,"state":37,"zip":119,"country":101,"cosmosGeoPoint":120,"geoPoint":124,"contacts":37},"CHU de Nice - Hopital L'Archet II","Nice","06200",{"type":63,"coordinates":121},[122,123],7.26608,43.70313,{"lat":123,"lon":122},{"facility":126,"status":57,"city":127,"state":37,"zip":128,"country":101,"cosmosGeoPoint":129,"geoPoint":133,"contacts":37},"Hôpital Saint Louis - AP-HP","Paris","75010",{"type":63,"coordinates":130},[131,132],2.3488,48.85341,{"lat":132,"lon":131},{"facility":135,"status":57,"city":136,"state":37,"zip":137,"country":101,"cosmosGeoPoint":138,"geoPoint":142,"contacts":37},"Centre Hospitalier Lyon Sud","Pierre-Bénite","69495",{"type":63,"coordinates":139},[140,141],4.82424,45.70359,{"lat":141,"lon":140},{"facility":144,"status":57,"city":145,"state":37,"zip":146,"country":147,"cosmosGeoPoint":148,"geoPoint":152,"contacts":37},"Marien Hospital Duesseldorf","Düsseldorf","40479","Germany",{"type":63,"coordinates":149},[150,151],6.77927,51.22319,{"lat":151,"lon":150},{"facility":154,"status":57,"city":155,"state":37,"zip":146,"country":147,"cosmosGeoPoint":156,"geoPoint":160,"contacts":37},"Klinik fur Innere Medizin IV - Hamatologie\u002FOnkologie, Universitatsklinikum Hall","Halle",{"type":63,"coordinates":157},[158,159],11.97947,51.48158,{"lat":159,"lon":158},{"facility":162,"status":57,"city":163,"state":37,"zip":164,"country":165,"cosmosGeoPoint":166,"geoPoint":170,"contacts":37},"IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola","Bologna","40138","Italy",{"type":63,"coordinates":167},[168,169],11.33875,44.49381,{"lat":169,"lon":168},{"facility":172,"status":57,"city":173,"state":37,"zip":174,"country":165,"cosmosGeoPoint":175,"geoPoint":179,"contacts":37},"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano","Milan","20122",{"type":63,"coordinates":176},[177,178],12.59836,42.78235,{"lat":178,"lon":177},{"facility":181,"status":57,"city":182,"state":37,"zip":183,"country":165,"cosmosGeoPoint":184,"geoPoint":188,"contacts":37},"Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia","Perugia","06129",{"type":63,"coordinates":185},[186,187],12.38878,43.1122,{"lat":187,"lon":186},{"facility":190,"status":57,"city":191,"state":37,"zip":192,"country":193,"cosmosGeoPoint":194,"geoPoint":198,"contacts":37},"Pratia Onkologia Katowice","Katowice","40-519","Poland",{"type":63,"coordinates":195},[196,197],19.02173,50.2597,{"lat":197,"lon":196},{"facility":200,"status":57,"city":201,"state":37,"zip":202,"country":203,"cosmosGeoPoint":204,"geoPoint":208,"contacts":37},"Hospital Universitari Arnau de Vilanova","Lleida","25198","Spain",{"type":63,"coordinates":205},[206,207],0.62218,41.61674,{"lat":207,"lon":206},{"facility":210,"status":57,"city":211,"state":37,"zip":212,"country":203,"cosmosGeoPoint":213,"geoPoint":217,"contacts":37},"Hospital Universitario Ramon y Cajal","Madrid","28034",{"type":63,"coordinates":214},[215,216],-3.70256,40.4165,{"lat":216,"lon":215},{"facility":219,"status":57,"city":220,"state":37,"zip":221,"country":203,"cosmosGeoPoint":222,"geoPoint":226,"contacts":37},"Hospital Universitario Virgen de la Victoria","Málaga","29010",{"type":63,"coordinates":223},[224,225],-4.42034,36.72016,{"lat":225,"lon":224},{"facility":228,"status":57,"city":229,"state":37,"zip":230,"country":203,"cosmosGeoPoint":231,"geoPoint":235,"contacts":37},"Hospital Quironsalud de Zaragoza","Zaragoza","50006",{"type":63,"coordinates":232},[233,234],-0.87734,41.65606,{"lat":234,"lon":233},{"type":237,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100460813",false,"NCT05280509","Study of TL-895 Combined With Ruxolitinib in JAKi Treatment-Naïve MF Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib","An Open-Label, Multicenter, Phase 1b\u002F2 Study of the Safety and Efficacy of TL-895 Combined With Ruxolitinib in Janus-associated Kinase Inhibitor (JAKi) Treatment-Naïve Myelofibrosis (MF) Subjects and Subjects With MF Who Have a Suboptimal Response to Ruxolitinib","Inclusion Criteria:\n\nSubjects with suboptimal response to ruxolitinib:\n\n* Treatment with at a stable dose of ruxolitinib prior to study entry\n* Subjects ≥ 18 years of age and able to provide informed consent.\n* Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by treating physician according to the World Health Organization (WHO) criteria\n* High-risk, intermediate-2 risk, or intermediate-1 risk, defined by Dynamic International Prognostic System (DIPSS)\n* Palpable spleen measuring ≥ 5 cm below the left lower coastal margin (LLCM) or spleen volume of ≥ 450 cm3 by MRI or CT scan assessment\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2\n* Adequate hematological, hepatic, \\& renal function.\n\nExclusion Criteria:\n\nTreatment-naive subjects:\n\n* Prior treatment with any JAKi\n\nSubjects with suboptimal response to ruxolitinib:\n\n* Documented disease progression while on ruxolitinib treatment\n\nAll subjects:\n\n* Prior splenectomy or splenic irradiation within 24 weeks prior to first dose of study treatment\n* Prior treatment with a BTK or BMX inhibitor","ALL","18 Years",{"count":247,"type":248},70,"ESTIMATED","INTERVENTIONAL",[251,252],"PHASE1","PHASE2","This study evaluates TL-895, a potent, orally-available and highly selective irreversible tyrosine kinase inhibitor for the treatment of Myelofibrosis. Participants must have MF (PMF, Post PV MF, or Post ET MF) who are JAKi treatment-naïve or those who have a suboptimal response to ruxolitinib.",[255,256,257,258],"Myelofibrosis","Primary Myelofibrosis","Post-PV MF","Post-ET Myelofibrosis",[255],"2023-02-16",{"date":262,"type":263},"2023-02-21","ACTUAL",{"date":265,"type":263},"2022-06-09",{"date":267,"type":248},"2027-04",{"name":5,"class":6},19]