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Amadori\"","Meldola","47014",{"type":60,"coordinates":859},[860,861],12.0626,44.12775,{"lat":861,"lon":860},[864],{"name":428,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":866,"status":53,"city":867,"state":11,"zip":868,"country":815,"countryCode":816,"cosmosGeoPoint":869,"geoPoint":873,"contacts":874},"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico","Milan","20122",{"type":60,"coordinates":870},[871,872],9.18951,45.46427,{"lat":872,"lon":871},[875],{"name":428,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":877,"status":53,"city":878,"state":11,"zip":879,"country":815,"countryCode":816,"cosmosGeoPoint":880,"geoPoint":884,"contacts":885},"Azienda Ospedaliera Universitaria Citta' Della Salute E della Scienza di Torino","Torino","10126",{"type":60,"coordinates":881},[882,883],11.99138,44.88856,{"lat":883,"lon":882},[886],{"name":428,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":888,"status":53,"city":889,"state":11,"zip":11,"country":890,"countryCode":891,"cosmosGeoPoint":892,"geoPoint":896,"contacts":897},"Aichi Medical University Hospital","Aichi","Japan","JP",{"type":60,"coordinates":893},[894,895],130.62158,32.51879,{"lat":895,"lon":894},[898],{"name":899,"role":44,"phone":900,"phoneExt":11,"email":901},"Akiyoshi Takami","0561-62-3311","takami.akiyoshi.490@mail.aichi-med-u.ac.jp",{"facility":903,"status":53,"city":904,"state":11,"zip":11,"country":890,"countryCode":891,"cosmosGeoPoint":905,"geoPoint":909,"contacts":910},"Aomori Prefectural Central Hospital","Aomori",{"type":60,"coordinates":906},[907,908],140.73333,40.81667,{"lat":908,"lon":907},[911],{"name":912,"role":44,"phone":913,"phoneExt":11,"email":914},"Tomoaki Akagi, 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University Hospital","Hokkaido",[945],{"name":946,"role":44,"phone":947,"phoneExt":11,"email":948},"Takanori Teshima, MD","011-716-1161","teshima@med.hokudai.ac.jp",{"facility":950,"status":53,"city":951,"state":11,"zip":952,"country":890,"countryCode":891,"cosmosGeoPoint":953,"geoPoint":957,"contacts":958},"Shonan Kamakura General Hospital","Kamakura","247-8533",{"type":60,"coordinates":954},[955,956],139.54698,35.31085,{"lat":956,"lon":955},[959],{"name":960,"role":44,"phone":961,"phoneExt":11,"email":962},"Tomiteru Togano, MD","0467-46-1717","t_togano@shonankamakura.or.jp",{"facility":964,"status":53,"city":965,"state":11,"zip":11,"country":890,"countryCode":891,"cosmosGeoPoint":966,"geoPoint":970,"contacts":971},"University of Miyazaki Hospital","Miyazaki",{"type":60,"coordinates":967},[968,969],131.41667,31.91667,{"lat":969,"lon":968},[972],{"name":973,"role":44,"phone":974,"phoneExt":11,"email":975},"Kazuya Shimoda, 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Center","Saitama",{"type":60,"coordinates":1005},[1006,1007],139.65657,35.90807,{"lat":1007,"lon":1006},{"facility":1010,"status":53,"city":1011,"state":11,"zip":11,"country":890,"countryCode":891,"cosmosGeoPoint":1012,"geoPoint":1016,"contacts":1017},"Tohoku University Hospital","Sendai",{"type":60,"coordinates":1013},[1014,1015],140.86667,38.26667,{"lat":1015,"lon":1014},[1018],{"name":1019,"role":44,"phone":1020,"phoneExt":11,"email":11},"Noriko Fukuhara, MD","022-717-7000",{"facility":1022,"status":158,"city":1023,"state":11,"zip":11,"country":890,"countryCode":891,"cosmosGeoPoint":1024,"geoPoint":1028,"contacts":11},"Shizuoka Cancer Center","Shizuoka",{"type":60,"coordinates":1025},[1026,1027],138.38333,34.98333,{"lat":1027,"lon":1026},{"facility":1030,"status":53,"city":1031,"state":11,"zip":1032,"country":890,"countryCode":891,"cosmosGeoPoint":1033,"geoPoint":1037,"contacts":1038},"Tokyo Medical University Hospital","Tokyo","160-0023",{"type":60,"coordinates":1034},[1035,1036],139.69171,35.6895,{"lat":1036,"lon":1035},[1039],{"name":1040,"role":44,"phone":1041,"phoneExt":11,"email":1042},"Daigo Akahane, MD","03-3342-6111","dakahane@tokyo-med.ac.jp",{"facility":1044,"status":53,"city":1031,"state":11,"zip":11,"country":890,"countryCode":891,"cosmosGeoPoint":1045,"geoPoint":1047,"contacts":1048},"Juntendo University Hospital",{"type":60,"coordinates":1046},[1035,1036],{"lat":1036,"lon":1035},[1049],{"name":1050,"role":44,"phone":1051,"phoneExt":11,"email":1052},"Shuichi Shirane, MD","03-3813-3111","sshirane@juntendo.ac.jp",{"facility":1054,"status":53,"city":1055,"state":11,"zip":11,"country":890,"countryCode":891,"cosmosGeoPoint":1056,"geoPoint":1060,"contacts":1061},"Mie University Hospital","Tsu",{"type":60,"coordinates":1057},[1058,1059],136.51667,34.73333,{"lat":1059,"lon":1058},[1062],{"name":1063,"role":44,"phone":1064,"phoneExt":11,"email":1065},"Yuka Sugimoto, MD","059-232-1111","yuka2@clin.medic.mie-u.ac.jp",{"facility":1067,"status":53,"city":1068,"state":11,"zip":11,"country":1069,"countryCode":1070,"cosmosGeoPoint":1071,"geoPoint":1075,"contacts":1076},"Hospital Universitario y Politecnico La Fe","Barcelona","Spain","ES",{"type":60,"coordinates":1072},[1073,1074],2.15899,41.38879,{"lat":1074,"lon":1073},[1077],{"name":428,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":1079,"status":53,"city":1068,"state":11,"zip":11,"country":1069,"countryCode":1070,"cosmosGeoPoint":1080,"geoPoint":1082,"contacts":1083},"Institut Catala d'Oncologia",{"type":60,"coordinates":1081},[1073,1074],{"lat":1074,"lon":1073},[1084],{"name":428,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":1086,"status":53,"city":1087,"state":11,"zip":11,"country":1069,"countryCode":1070,"cosmosGeoPoint":1088,"geoPoint":1092,"contacts":1093},"Hospital Universitario de Salamanca","Salamanca",{"type":60,"coordinates":1089},[1090,1091],-3.67975,40.42972,{"lat":1091,"lon":1090},[1094],{"name":428,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":1096,"status":53,"city":1097,"state":11,"zip":11,"country":1098,"countryCode":1099,"cosmosGeoPoint":1100,"geoPoint":1104,"contacts":1105},"Lincoln County Hospital","Lincoln","United Kingdom","UK",{"type":60,"coordinates":1101},[1102,1103],-0.53792,53.22683,{"lat":1103,"lon":1102},[1106],{"name":428,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":1108,"status":53,"city":1097,"state":11,"zip":11,"country":1098,"countryCode":1099,"cosmosGeoPoint":1109,"geoPoint":1111,"contacts":1112},"United Lincolnshire Hospitals NHS Trust - Pilgrim Hospital",{"type":60,"coordinates":1110},[1102,1103],{"lat":1103,"lon":1102},[1113],{"name":428,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":1115,"status":53,"city":1116,"state":11,"zip":11,"country":1098,"countryCode":1099,"cosmosGeoPoint":1117,"geoPoint":1121,"contacts":1122},"University College London Hospital's NHS foundation Trust","London",{"type":60,"coordinates":1118},[1119,1120],-0.12574,51.50853,{"lat":1120,"lon":1119},[1123],{"name":428,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":1125,"status":53,"city":1126,"state":11,"zip":11,"country":1098,"countryCode":1099,"cosmosGeoPoint":1127,"geoPoint":1131,"contacts":1132},"Oxford University Hospitals NHS Foundation","Oxford",{"type":60,"coordinates":1128},[1129,1130],-1.25596,51.75222,{"lat":1130,"lon":1129},[1133],{"name":428,"role":44,"phone":11,"phoneExt":11,"email":11},{"type":1135,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100376029","phase-1-a-study-of-oral-nuvisertib-tp-3654-in-patients-with-myelofibrosis-100376029",false,"NCT04176198","A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis","A Phase 1\u002F2, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral Nuvisertib (TP-3654) in Patients With Intermediate or High-Risk Primary or Secondary Myelofibrosis","Patients must meet all of the following inclusion criteria to be eligible:\n\nNuvisertib (TP-3654) Monotherapy Arm:\n\n* Confirmed pathological diagnosis of primary myelofibrosis (PMF) or post-PV-MF\u002Fpost-ET- MF and intermediate or high-risk primary or secondary MF\n* Previously treated with JAK inhibitor(s) and is intolerant, resistant, refractory or has lost response to the JAK inhibitor(s) or is ineligible to be treated with JAK inhibitor\n* Fulfill the following clinical laboratory parameters:\n* Platelet count ≥ 25 x 10\\^9 \u002FL, without assistance of growth factors or platelet transfusions\n* ANC ≥ 1 x 10\\^9\u002FL without assistance of granulocyte growth factors\n* Peripheral blood blast count \\\u003C 5%\n* ECOG performance status ≤ 1\n* Life expectancy ≥ 6 months\n* Adequate renal function\n* Adequate hepatic function\n* Adequate coagulation function\n* Splenomegaly (spleen volume of ≥ 450 cm3 by MRI or CT scan) within 2 weeks prior to Cycle 1 Day 1.\n* Dose escalation: At least 2 symptoms measurable (score ≥ 1) using the MF-SAF\n* Dose expansion: At least 2 symptoms measurable with each score of ≥ 3 or a total average score of ≥ 10 per MFSAF\n\nNuvisertib (TP-3654) + Ruxolitinib Arm:\n\n* Confirmed pathological diagnosis of PMF or post-PV-MF\u002Fpost ET- MF and intermediate or high-risk primary or secondary MF\n* On ruxolitinib treatment for ≥ 6 months, and on a stable dose of ruxolitinib (5 to 25 mg BID) for ≥ 8 weeks prior to the first dose of nuvisertib, but has either lost response or had a suboptimal or plateau in response\n* Fulfills the following clinical laboratory parameters:\n* Platelet count ≥ 50 × 10\\^9\u002FL (without assistance of growth factors or platelet transfusions)\n* ANC ≥ 1 × 109\u002FL without assistance of granulocyte growth factors\n* Peripheral blood blast count \\\u003C 5% at screening\n* Adequate renal function\n* Adequate hepatic function\n* Adequate coagulation function\n* Splenomegaly (spleen volume of ≥ 450 cm3 by MRI\u002FCT scan) within 2 weeks prior to Cycle 1 Day 1\n* At least 2 symptoms measurable with each score ≥ 3 or a total average score of ≥ 10 per MFSAF v4.0\n* ECOG performance status ≤ 1\n* Life expectancy ≥ 6 months\n\nNuvisertib (TP-3654) + Momelotinib Arm\n\n* Confirmed pathological diagnosis of PMF or post-PV-MF\u002Fpost ET-MF and intermediate or high-risk primary or secondary MF\n* Previously treated with an approved JAK inhibitor (except momelotinib) for PMF or Post-PV\u002FET MF for ≥ 12 weeks, or ≥ 4 weeks if JAK inhibitor therapy was complicated by a transfusion requirement of ≥ 4 units of red blood cells in 8 weeks, or Grade 3\u002F4 AEs of thrombocytopenia, anemia, or hematoma\n* Fulfills the following clinical laboratory parameters:\n* Anemic, defined as Hb \\\u003C10 g\u002FdL or requiring RBC transfusion at baseline\n* Platelet count ≥ 50 × 109\u002FL (without assistance of growth factors or platelet transfusions)\n* ANC ≥ 1 × 109\u002FL without assistance of granulocyte growth factors\n* Peripheral blood blast count \\\u003C 5% at screening\n* Adequate renal function\n* Adequate hepatic function\n* Adequate coagulation function\n* Splenomegaly (spleen volume of ≥ 450 cm3 by MRI\u002FCT scan) within 2 weeks prior to Cycle 1 Day 1\n* At least 2 symptoms measurable with each score of ≥ 3 or a total average score of ≥ 10 per MFSAF v4.0\n* ECOG performance status ≤ 1\n* Life expectancy ≥ 6 months\n\nPatients meeting any one of these exclusion criteria will be prohibited from participating in this study:\n\nNuvisertib (TP-3654) Monotherapy Arm:\n\n* Received previous systemic antineoplastic therapy or any experimental therapy within 2 weeks or 5 half-lives, whichever is longer, prior to Cycle 1 Day 1. Hydroxyurea or anagrelide are allowed up to 24 hours prior to Cycle 1 Day 1).\n* Major surgery within 4 weeks prior to Cycle 1 Day 1 and\u002For not recovered adequately from from surgery prior to first dose.\n* Splenic irradiation within 6 months prior to Screening or prior splenectomy.\n* Prior allogeneic stem cell transplant within the last 6 months.\n* Eligible for allogeneic bone marrow or stem cell transplantation.\n* Unresolved Grade ≥ 2 non-hematological toxicity related to prior treatment\n* History of symptomatic congestive heart failure, or myocardial infarction, or uncontrolled arrhythmia within 6 months prior to Cycle 1 Day 1; left ventricular ejection fraction (LVEF) \\\u003C 45% by echocardiogram within 4 weeks prior to Cycle 1 Day 1.\n* Corrected QT interval \\> 480msec.\n* Prior or concurrent malignancy that could interfere with the investigational regime.\n* Known history of chronic liver disease, e.g. portal hypertension or any of its complications, cirrhosis, Child-Pugh C, auto-immune hepatitis, alpha-1 anti-trypsin deficiency, Wilson's disease, etc.\n* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic antimicrobial within 1 week prior to Cycle 1 Day 1.\n* Chronic active or acute viral hepatitis A, B, or C infection (testing for hepatitis B and C are required)\n* Exhibited allergic reactions or sensitivity to nuvisertib, or similar compound.\n* Medical condition or GI tract surgery that could impair absorption or result in short bowel syndrome with diarrhea.\n* Systemic steroid therapy (\\>10 mg daily prednisone or equivalent) within 1 week prior to the first dose of study treatment (note: topical, inhaled, nasal, and ophthalmic steroids are not prohibited).\n* Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or thalassemia, or severe GI bleeding.\n* Pregnant or breastfeeding\n* Currently receiving any other investigational agent.\n\nNuvisertib (TP-3654) + Ruxolitinib Arm:\n\n* Received previous systemic antineoplastic therapy (other than ruxolitinib) or any other experimental therapy within 2 weeks or 5 half-lives, whichever is longer, prior to Cycle 1 Day 1 (Note: Prior treatment with nuvisertib is not allowed. Hydroxyurea or anagrelide are allowed up to 24 hours prior to Cycle 1 Day 1).\n* Received systemic steroid therapy (\\>10 mg daily prednisone or equivalent) within 1 week prior to Cycle 1 Day 1 (Note: Topical, inhaled, nasal, and ophthalmic steroids are not prohibited)\n* Known allergic reactions or sensitivity to nuvisertib, or similar compound.\n* Splenic irradiation within 6 months prior to Screening or prior splenectomy\n* Prior allogeneic stem cell transplant within the last 6 months (Note: Patients who have relapsed after 6 months post-transplant and do not have active GVHD are eligible).\n* Eligible for allogeneic bone marrow or stem cell transplantation (Note: Patients who are not willing to undergo transplantation or for whom a suitable donor is not available are considered as transplant ineligible.)\n* Major surgery within 4 weeks prior to Cycle 1 Day 1 and\u002For have not recovered adequately prior to first dose.\n* Active, uncontrolled bacterial, viral, or fungal infections, requiring parenteral antimicrobial within 1 week prior to Cycle 1 Day 1\n* Chronic active or acute viral hepatitis A, B, or C infection (testing for hepatitis B and C are required)\n* Known history of chronic liver disease (eg, portal hypertension or any of its complications, cirrhosis, Child-Pugh C, auto-immune hepatitis, alpha-1 anti-trypsin deficiency, Wilson's disease, etc) (Note: Abnormal liver morphology at baseline imaging may require additional testing, as needed).\n* Unresolved Grade ≥ 2 non-hematological adverse events related to prior treatment (stable Grade 2 conditions may be permitted in consultation with the Sponsor)\n* History of myocardial infarction or symptomatic congestive heart failure or uncontrolled arrhythmia within 6 months prior to Cycle 1 Day 1; LVEF \\\u003C45% by echocardiogram within 4 weeks prior to Cycle 1 Day 1\n* Corrected QTcF of \\> 480 msec\n* Prior or concurrent malignancy that could interfere with the safety or efficacy assessment of the study intervention\n* History of a medical condition or GI tract surgery that could impair absorption or could result in short bowel syndrome with diarrhea\n* Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or thalassemia, or severe GI bleeding\n* Pregnant or breastfeeding\n\nNuvisertib (TP-3654) + Momelotinib Arm:\n\n* Received previous systemic antineoplastic therapy or any experimental therapy within 2 weeks or 5 half-lives, whichever is longer, prior to Cycle 1 Day 1 (Notes: Prior treatment with momelotinib or nuvisertib is not allowed; in patients with ongoing JAK inhibitor therapy, ie, ruxolitinib, at screening, JAK inhibitor therapy must be tapered over a period of at least 1 week. Patients on a low dose of ruxolitinib (eg, 5 mg QD) may have a reduced taper period or no taper; hydroxyurea or anagrelide are allowed up to 24 hours prior to Cycle 1 Day 1).\n* Received systemic steroid therapy (\\>10 mg daily prednisone or equivalent) within 1 week prior to Cycle 1 Day 1 (Note: Topical, inhaled, nasal, and ophthalmic steroids are not prohibited).\n* Known allergic reactions or sensitivity to nuvisertib, momelotinib, or any structurally similar drug, or to any component of the formulations of either study intervention\n* Splenic irradiation within 6 months prior to screening or prior splenectomy\n* Prior allogenic stem cell transplant within the last 6 months (Note: Patients who have relapsed after 6 months post-transplant and do not have active GVHD are eligible).\n* Eligible for allogeneic bone marrow or stem cell transplantation (Note: Patients who are not willing to undergo transplantation or for whom a suitable donor is not available are considered as transplant ineligible).\n* Major surgery within 4 weeks prior to Cycle 1 Day 1 and\u002For have not recovered adequately from surgery prior to first dose.\n* Active, uncontrolled bacterial, viral, or fungal infections, requiring parenteral antimicrobial within 1 week prior to Cycle 1 Day 1\n* Chronic active or acute viral hepatitis A, B, or C infection (testing for hepatitis B and C are required)\n* Known history of chronic liver disease (eg, portal hypertension or any of its complications, cirrhosis, Child-Pugh C, auto-immune hepatitis, alpha-1 anti-trypsin deficiency, Wilson's disease, etc) (Note: Abnormal liver morphology at baseline imaging may require additional testing, as needed)\n* Unresolved Grade ≥ 2 non-hematological adverse events related to prior treatment (stable Grade 2 conditions may be permitted in consultation with the Sponsor)\n* Presence of Grade ≥ 2 peripheral neuropathy\n* History of myocardial infarction or symptomatic congestive heart failure or uncontrolled arrhythmia within 6 months prior to Cycle 1 Day 1; LVEF \\\u003C 45% by echocardiogram within 4 weeks prior to Cycle 1 Day 1\n* Corrected QTcF of \\> 480 msec\n* Prior or concurrent malignancy that could interfere with the safety or efficacy assessment of the study intervention\n* History of a medical condition or GI tract surgery that could impair absorption or could result in short bowel syndrome with diarrhea\n* Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or thalassemia, or severe GI bleeding\n* Pregnant or breastfeeding","ALL","18 Years",{"count":1146,"type":1147},240,"ESTIMATED","INTERVENTIONAL",[1150,1151],"PHASE1","PHASE2","This study is a Phase 1\u002F2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of nuvisertib (TP-3654) in patients with intermediate or high-risk primary or secondary MF.",[1154],"Myelofibrosis","2026-07-31",{"date":1157,"type":1158},"2026-08-03","ACTUAL",{"date":1160,"type":1158},"2019-12-16",{"date":1162,"type":1147},"2030-04-30",{"name":5,"class":6},90]