[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100460813":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":37,"centralContacts":45,"locations":54,"responsibleParty":242,"collaborators":37,"id":244,"slug":245,"hasResults":246,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":37,"eligibilityCriteria":250,"healthyVolunteers":246,"sex":251,"minAge":252,"maxAge":37,"enrollmentInfo":253,"targetDuration":37,"studyType":256,"phases":257,"briefSummary":260,"conditions":261,"keywords":266,"overallStatus":57,"whyStopped":37,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":276},{"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",[55,69,79,88,98,109,118,127,136,145,156,164,175,184,193,204,215,224,233],{"facility":56,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":37},"University of Alabama at Birmingham","RECRUITING","Birmingham","Alabama","35294","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-86.80249,33.52066,{"lat":67,"lon":66},{"facility":70,"status":57,"city":71,"state":72,"zip":73,"country":61,"countryCode":62,"cosmosGeoPoint":74,"geoPoint":78,"contacts":37},"Gabrail Cancer Center","Canton","Ohio","44718",{"type":64,"coordinates":75},[76,77],-81.37845,40.79895,{"lat":77,"lon":76},{"facility":80,"status":57,"city":81,"state":72,"zip":82,"country":61,"countryCode":62,"cosmosGeoPoint":83,"geoPoint":87,"contacts":37},"University of Cincinnati (UC)","Cincinnati","45267",{"type":64,"coordinates":84},[85,86],-84.51439,39.12711,{"lat":86,"lon":85},{"facility":89,"status":57,"city":90,"state":91,"zip":92,"country":61,"countryCode":62,"cosmosGeoPoint":93,"geoPoint":97,"contacts":37},"The University of Texas MD Anderson Cancer Center","Houston","Texas","77030",{"type":64,"coordinates":94},[95,96],-95.36327,29.76328,{"lat":96,"lon":95},{"facility":99,"status":57,"city":100,"state":37,"zip":101,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":108,"contacts":37},"CHU Angers","Angers","49100","France","FR",{"type":64,"coordinates":105},[106,107],-0.55202,47.47156,{"lat":107,"lon":106},{"facility":110,"status":57,"city":111,"state":37,"zip":112,"country":102,"countryCode":103,"cosmosGeoPoint":113,"geoPoint":117,"contacts":37},"AP-HM - Hôpital de la Timone","Marseille","13005",{"type":64,"coordinates":114},[115,116],5.38107,43.29695,{"lat":116,"lon":115},{"facility":119,"status":57,"city":120,"state":37,"zip":121,"country":102,"countryCode":103,"cosmosGeoPoint":122,"geoPoint":126,"contacts":37},"CHU de Nice - Hopital L'Archet II","Nice","06200",{"type":64,"coordinates":123},[124,125],7.26608,43.70313,{"lat":125,"lon":124},{"facility":128,"status":57,"city":129,"state":37,"zip":130,"country":102,"countryCode":103,"cosmosGeoPoint":131,"geoPoint":135,"contacts":37},"Hôpital Saint Louis - AP-HP","Paris","75010",{"type":64,"coordinates":132},[133,134],2.3488,48.85341,{"lat":134,"lon":133},{"facility":137,"status":57,"city":138,"state":37,"zip":139,"country":102,"countryCode":103,"cosmosGeoPoint":140,"geoPoint":144,"contacts":37},"Centre Hospitalier Lyon Sud","Pierre-Bénite","69495",{"type":64,"coordinates":141},[142,143],4.82424,45.70359,{"lat":143,"lon":142},{"facility":146,"status":57,"city":147,"state":37,"zip":148,"country":149,"countryCode":150,"cosmosGeoPoint":151,"geoPoint":155,"contacts":37},"Marien Hospital Duesseldorf","Düsseldorf","40479","Germany","DE",{"type":64,"coordinates":152},[153,154],6.77927,51.22319,{"lat":154,"lon":153},{"facility":157,"status":57,"city":158,"state":37,"zip":148,"country":149,"countryCode":150,"cosmosGeoPoint":159,"geoPoint":163,"contacts":37},"Klinik fur Innere Medizin IV - Hamatologie\u002FOnkologie, Universitatsklinikum Hall","Halle",{"type":64,"coordinates":160},[161,162],11.97947,51.48158,{"lat":162,"lon":161},{"facility":165,"status":57,"city":166,"state":37,"zip":167,"country":168,"countryCode":169,"cosmosGeoPoint":170,"geoPoint":174,"contacts":37},"IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant'Orsola","Bologna","40138","Italy","IT",{"type":64,"coordinates":171},[172,173],11.33875,44.49381,{"lat":173,"lon":172},{"facility":176,"status":57,"city":177,"state":37,"zip":178,"country":168,"countryCode":169,"cosmosGeoPoint":179,"geoPoint":183,"contacts":37},"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano","Milan","20122",{"type":64,"coordinates":180},[181,182],12.59836,42.78235,{"lat":182,"lon":181},{"facility":185,"status":57,"city":186,"state":37,"zip":187,"country":168,"countryCode":169,"cosmosGeoPoint":188,"geoPoint":192,"contacts":37},"Azienda Ospedaliera di Perugia-Ospedale S. Maria della Misericordia","Perugia","06129",{"type":64,"coordinates":189},[190,191],12.38878,43.1122,{"lat":191,"lon":190},{"facility":194,"status":57,"city":195,"state":37,"zip":196,"country":197,"countryCode":198,"cosmosGeoPoint":199,"geoPoint":203,"contacts":37},"Pratia Onkologia Katowice","Katowice","40-519","Poland","PL",{"type":64,"coordinates":200},[201,202],19.02173,50.2597,{"lat":202,"lon":201},{"facility":205,"status":57,"city":206,"state":37,"zip":207,"country":208,"countryCode":209,"cosmosGeoPoint":210,"geoPoint":214,"contacts":37},"Hospital Universitari Arnau de Vilanova","Lleida","25198","Spain","ES",{"type":64,"coordinates":211},[212,213],0.62218,41.61674,{"lat":213,"lon":212},{"facility":216,"status":57,"city":217,"state":37,"zip":218,"country":208,"countryCode":209,"cosmosGeoPoint":219,"geoPoint":223,"contacts":37},"Hospital Universitario Ramon y Cajal","Madrid","28034",{"type":64,"coordinates":220},[221,222],-3.70256,40.4165,{"lat":222,"lon":221},{"facility":225,"status":57,"city":226,"state":37,"zip":227,"country":208,"countryCode":209,"cosmosGeoPoint":228,"geoPoint":232,"contacts":37},"Hospital Universitario Virgen de la Victoria","Málaga","29010",{"type":64,"coordinates":229},[230,231],-4.42034,36.72016,{"lat":231,"lon":230},{"facility":234,"status":57,"city":235,"state":37,"zip":236,"country":208,"countryCode":209,"cosmosGeoPoint":237,"geoPoint":241,"contacts":37},"Hospital Quironsalud de Zaragoza","Zaragoza","50006",{"type":64,"coordinates":238},[239,240],-0.87734,41.65606,{"lat":240,"lon":239},{"type":243,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100460813","phase-1-study-of-tl-895-combined-with-ruxolitinib-in-jaki-treatment-nave-mf-subjects-and-subjects-with-mf-who-have-a-suboptimal-response-to-ruxolitinib-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":254,"type":255},70,"ESTIMATED","INTERVENTIONAL",[258,259],"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.",[262,263,264,265],"Myelofibrosis","Primary Myelofibrosis","Post-PV MF","Post-ET Myelofibrosis",[262],"2023-02-16",{"date":269,"type":270},"2023-02-21","ACTUAL",{"date":272,"type":270},"2022-06-09",{"date":274,"type":255},"2027-04",{"name":5,"class":6},19]