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Gard","Nîmes","30029",{"type":59,"coordinates":729},[730,731],4.35788,43.83665,{"lat":731,"lon":730},[734],{"name":427,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":725,"status":53,"city":726,"state":11,"zip":11,"country":684,"cosmosGeoPoint":736,"geoPoint":738,"contacts":739},{"type":59,"coordinates":737},[730,731],{"lat":731,"lon":730},[740],{"name":427,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":742,"status":53,"city":743,"state":11,"zip":744,"country":684,"cosmosGeoPoint":745,"geoPoint":749,"contacts":750},"Hospital Saint Louis","Paris","75010",{"type":59,"coordinates":746},[747,748],2.3488,48.85341,{"lat":748,"lon":747},[751],{"name":427,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":753,"status":53,"city":754,"state":11,"zip":755,"country":684,"cosmosGeoPoint":756,"geoPoint":760,"contacts":761},"University Hospital of Poitiers","Poitiers","86021",{"type":59,"coordinates":757},[758,759],0.34348,46.58261,{"lat":759,"lon":758},[762],{"name":427,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":764,"status":53,"city":765,"state":11,"zip":766,"country":684,"cosmosGeoPoint":767,"geoPoint":771,"contacts":772},"Institut Gustave Roussy","Villejuif","94805",{"type":59,"coordinates":768},[769,770],2.35992,48.7939,{"lat":770,"lon":769},[773],{"name":427,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":775,"status":53,"city":776,"state":11,"zip":777,"country":778,"cosmosGeoPoint":779,"geoPoint":783,"contacts":784},"Azienda Ospedaliera Nazionale SS. Antonio e Biagio e Cesare Arrigo","Alessandria","15121","Italy",{"type":59,"coordinates":780},[781,782],8.61007,44.90924,{"lat":782,"lon":781},[785],{"name":427,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":787,"status":53,"city":788,"state":11,"zip":789,"country":778,"cosmosGeoPoint":790,"geoPoint":794,"contacts":11},"Istituto Nazionale Tumori, IRCCS Centro di Riferimento Oncologico di Aviano","Aviano","33081",{"type":59,"coordinates":791},[792,793],12.59472,46.07056,{"lat":793,"lon":792},{"facility":796,"status":53,"city":797,"state":11,"zip":798,"country":778,"cosmosGeoPoint":799,"geoPoint":803,"contacts":804},"IRCCS Azienda Ospedaliero -Universitaria Di Bologna - Dipartimento Malattie Oncologiche ed Ematologiche - UO Ematologia","Bologna","40138",{"type":59,"coordinates":800},[801,802],11.33875,44.49381,{"lat":802,"lon":801},[805],{"name":427,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":807,"status":53,"city":808,"state":11,"zip":11,"country":778,"cosmosGeoPoint":809,"geoPoint":813,"contacts":814},"ASST - Spedali Civili di Brescia","Brescia",{"type":59,"coordinates":810},[811,812],10.21472,45.53558,{"lat":812,"lon":811},[815],{"name":427,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":817,"status":53,"city":818,"state":11,"zip":819,"country":778,"cosmosGeoPoint":820,"geoPoint":824,"contacts":825},"IRCCS istituto Romagnolo per lo studio dei tumori \"Dino Amadori\"","Meldola","47014",{"type":59,"coordinates":821},[822,823],12.0626,44.12775,{"lat":823,"lon":822},[826],{"name":427,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":828,"status":53,"city":829,"state":11,"zip":830,"country":778,"cosmosGeoPoint":831,"geoPoint":835,"contacts":836},"Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico","Milan","20122",{"type":59,"coordinates":832},[833,834],9.18951,45.46427,{"lat":834,"lon":833},[837],{"name":427,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":839,"status":53,"city":840,"state":11,"zip":841,"country":778,"cosmosGeoPoint":842,"geoPoint":846,"contacts":847},"Azienda Ospedaliera Universitaria Citta' Della Salute E della Scienza di Torino","Torino","10126",{"type":59,"coordinates":843},[844,845],11.99138,44.88856,{"lat":845,"lon":844},[848],{"name":427,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":850,"status":53,"city":851,"state":11,"zip":11,"country":852,"cosmosGeoPoint":853,"geoPoint":857,"contacts":858},"Aichi Medical University Hospital","Aichi","Japan",{"type":59,"coordinates":854},[855,856],130.62158,32.51879,{"lat":856,"lon":855},[859],{"name":860,"role":44,"phone":861,"phoneExt":11,"email":862},"Akiyoshi Takami","0561-62-3311","takami.akiyoshi.490@mail.aichi-med-u.ac.jp",{"facility":864,"status":53,"city":865,"state":11,"zip":11,"country":852,"cosmosGeoPoint":866,"geoPoint":870,"contacts":871},"Aomori Prefectural Central Hospital","Aomori",{"type":59,"coordinates":867},[868,869],140.73333,40.81667,{"lat":869,"lon":868},[872],{"name":873,"role":44,"phone":874,"phoneExt":11,"email":875},"Tomoaki Akagi, MD","017-726-8111","tomakagi@med.pref.aomori.jp",{"facility":877,"status":53,"city":878,"state":11,"zip":11,"country":852,"cosmosGeoPoint":879,"geoPoint":883,"contacts":884},"National Cancer Center Hospital East","Chiba",{"type":59,"coordinates":880},[881,882],140.11667,35.6,{"lat":882,"lon":881},[885],{"name":886,"role":44,"phone":887,"phoneExt":11,"email":888},"Junichiro Yuda, MD","04-7133-1111","jyuda@east.ncc.go.jp",{"facility":890,"status":53,"city":891,"state":11,"zip":11,"country":852,"cosmosGeoPoint":892,"geoPoint":896,"contacts":897},"Kyushu University Hospital","Fukuoka",{"type":59,"coordinates":893},[894,895],130.41667,33.6,{"lat":895,"lon":894},[898],{"name":899,"role":44,"phone":900,"phoneExt":11,"email":901},"Takuji Yamauchi, MD","092-641-1151","yamauchi.takuji.355@m.kyushu-u.ac.jp",{"facility":903,"status":53,"city":904,"state":11,"zip":11,"country":852,"cosmosGeoPoint":11,"geoPoint":11,"contacts":905},"Hokkaido University Hospital","Hokkaido",[906],{"name":907,"role":44,"phone":908,"phoneExt":11,"email":909},"Takanori Teshima, MD","011-716-1161","teshima@med.hokudai.ac.jp",{"facility":911,"status":53,"city":912,"state":11,"zip":913,"country":852,"cosmosGeoPoint":914,"geoPoint":918,"contacts":919},"Shonan Kamakura General Hospital","Kamakura","247-8533",{"type":59,"coordinates":915},[916,917],139.54698,35.31085,{"lat":917,"lon":916},[920],{"name":921,"role":44,"phone":922,"phoneExt":11,"email":923},"Tomiteru Togano, MD","0467-46-1717","t_togano@shonankamakura.or.jp",{"facility":925,"status":53,"city":926,"state":11,"zip":11,"country":852,"cosmosGeoPoint":927,"geoPoint":931,"contacts":932},"University of Miyazaki Hospital","Miyazaki",{"type":59,"coordinates":928},[929,930],131.41667,31.91667,{"lat":930,"lon":929},[933],{"name":934,"role":44,"phone":935,"phoneExt":11,"email":936},"Kazuya Shimoda, MD","0985-85-1510","kshimoda@med.miyazaki-u.ac.jp",{"facility":938,"status":53,"city":939,"state":11,"zip":11,"country":852,"cosmosGeoPoint":940,"geoPoint":944,"contacts":945},"Okayama University Hospital","Okayama",{"type":59,"coordinates":941},[942,943],133.93333,34.65,{"lat":943,"lon":942},[946],{"name":947,"role":44,"phone":948,"phoneExt":11,"email":949},"Noboru Asada, MD","086-223-7151","nasada@okayama-u.ac.jp",{"facility":951,"status":53,"city":952,"state":11,"zip":11,"country":852,"cosmosGeoPoint":953,"geoPoint":957,"contacts":958},"The University of Osaka Hospital","Osaka",{"type":59,"coordinates":954},[955,956],135.50107,34.69379,{"lat":956,"lon":955},[959],{"name":960,"role":44,"phone":961,"phoneExt":11,"email":11},"Michiko Ichii, MD","06-6879-5111",{"facility":963,"status":53,"city":964,"state":11,"zip":11,"country":852,"cosmosGeoPoint":965,"geoPoint":969,"contacts":970},"Saitama Medical Center","Saitama",{"type":59,"coordinates":966},[967,968],139.65657,35.90807,{"lat":968,"lon":967},[971],{"name":972,"role":44,"phone":973,"phoneExt":11,"email":974},"Takayuki Tabayashi","049-228-3411","ttabaya@saitama-med.ac.jp",{"facility":976,"status":53,"city":977,"state":11,"zip":11,"country":852,"cosmosGeoPoint":978,"geoPoint":982,"contacts":983},"Tohoku University Hospital","Sendai",{"type":59,"coordinates":979},[980,981],140.86667,38.26667,{"lat":981,"lon":980},[984],{"name":985,"role":44,"phone":986,"phoneExt":11,"email":11},"Noriko Fukuhara, MD","022-717-7000",{"facility":988,"status":157,"city":989,"state":11,"zip":11,"country":852,"cosmosGeoPoint":990,"geoPoint":994,"contacts":11},"Shizuoka Cancer Center","Shizuoka",{"type":59,"coordinates":991},[992,993],138.38333,34.98333,{"lat":993,"lon":992},{"facility":996,"status":53,"city":997,"state":11,"zip":998,"country":852,"cosmosGeoPoint":999,"geoPoint":1003,"contacts":1004},"Tokyo Medical University Hospital","Tokyo","160-0023",{"type":59,"coordinates":1000},[1001,1002],139.69171,35.6895,{"lat":1002,"lon":1001},[1005],{"name":1006,"role":44,"phone":1007,"phoneExt":11,"email":1008},"Daigo Akahane, MD","03-3342-6111","dakahane@tokyo-med.ac.jp",{"facility":1010,"status":53,"city":997,"state":11,"zip":11,"country":852,"cosmosGeoPoint":1011,"geoPoint":1013,"contacts":1014},"Juntendo University Hospital",{"type":59,"coordinates":1012},[1001,1002],{"lat":1002,"lon":1001},[1015],{"name":1016,"role":44,"phone":1017,"phoneExt":11,"email":1018},"Shuichi Shirane, MD","03-3813-3111","sshirane@juntendo.ac.jp",{"facility":1020,"status":53,"city":1021,"state":11,"zip":11,"country":852,"cosmosGeoPoint":1022,"geoPoint":1026,"contacts":1027},"Mie University Hospital","Tsu",{"type":59,"coordinates":1023},[1024,1025],136.51667,34.73333,{"lat":1025,"lon":1024},[1028],{"name":1029,"role":44,"phone":1030,"phoneExt":11,"email":1031},"Yuka Sugimoto, MD","059-232-1111","yuka2@clin.medic.mie-u.ac.jp",{"facility":1033,"status":53,"city":1034,"state":11,"zip":11,"country":1035,"cosmosGeoPoint":1036,"geoPoint":1040,"contacts":1041},"Lincoln County Hospital","Lincoln","United Kingdom",{"type":59,"coordinates":1037},[1038,1039],-0.53792,53.22683,{"lat":1039,"lon":1038},[1042],{"name":427,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":1044,"status":53,"city":1034,"state":11,"zip":11,"country":1035,"cosmosGeoPoint":1045,"geoPoint":1047,"contacts":1048},"United Lincolnshire Hospitals NHS Trust - Pilgrim Hospital",{"type":59,"coordinates":1046},[1038,1039],{"lat":1039,"lon":1038},[1049],{"name":427,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":1051,"status":53,"city":1052,"state":11,"zip":11,"country":1035,"cosmosGeoPoint":1053,"geoPoint":1057,"contacts":1058},"University College London Hospital's NHS foundation Trust","London",{"type":59,"coordinates":1054},[1055,1056],-0.12574,51.50853,{"lat":1056,"lon":1055},[1059],{"name":427,"role":44,"phone":11,"phoneExt":11,"email":11},{"facility":1061,"status":53,"city":1062,"state":11,"zip":11,"country":1035,"cosmosGeoPoint":1063,"geoPoint":1067,"contacts":1068},"Oxford University Hospitals NHS Foundation","Oxford",{"type":59,"coordinates":1064},[1065,1066],-1.25596,51.75222,{"lat":1066,"lon":1065},[1069],{"name":427,"role":44,"phone":11,"phoneExt":11,"email":11},{"type":1071,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":1081,"type":1082},240,"ESTIMATED","INTERVENTIONAL",[1085,1086],"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.",[1089],"Myelofibrosis","2026-04-30",{"date":1092,"type":1093},"2026-05-01","ACTUAL",{"date":1095,"type":1093},"2019-12-16",{"date":1097,"type":1082},"2030-04-30",{"name":5,"class":6},84]