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Instituto de Estudios de Mastocitosis de Castilla-La Mancha","Toledo","45071",{"type":193,"coordinates":888},[889,890],-4.02263,39.8581,{"lat":890,"lon":889},{"facility":893,"status":186,"city":894,"state":11,"zip":895,"country":896,"countryCode":897,"cosmosGeoPoint":898,"geoPoint":902,"contacts":11},"Karolinska Universitetssjukhuset Huddinge","Stockholm","141 57","Sweden","SE",{"type":193,"coordinates":899},[900,901],18.06871,59.32938,{"lat":901,"lon":900},{"facility":904,"status":186,"city":905,"state":11,"zip":906,"country":896,"countryCode":897,"cosmosGeoPoint":907,"geoPoint":911,"contacts":11},"Uppsala University Hospital","Uppsala","751 85",{"type":193,"coordinates":908},[909,910],17.63889,59.85882,{"lat":910,"lon":909},{"facility":913,"status":186,"city":914,"state":11,"zip":915,"country":916,"countryCode":917,"cosmosGeoPoint":918,"geoPoint":922,"contacts":11},"University Hospital Basel","Basel","C-4031","Switzerland","CH",{"type":193,"coordinates":919},[920,921],7.57327,47.55839,{"lat":921,"lon":920},{"facility":924,"status":186,"city":925,"state":11,"zip":926,"country":916,"countryCode":917,"cosmosGeoPoint":927,"geoPoint":931,"contacts":11},"Luzerner Kantonsspital","Lucerne","6000",{"type":193,"coordinates":928},[929,930],8.30635,47.05048,{"lat":930,"lon":929},{"facility":933,"status":186,"city":934,"state":11,"zip":935,"country":936,"countryCode":11,"cosmosGeoPoint":937,"geoPoint":941,"contacts":11},"Ankara Universitesi Tip Fakultesi Cebeci Hastanesi","Ankara","06620","Turkey (Türkiye)",{"type":193,"coordinates":938},[939,940],32.85427,39.91987,{"lat":940,"lon":939},{"facility":943,"status":186,"city":944,"state":11,"zip":945,"country":936,"countryCode":11,"cosmosGeoPoint":946,"geoPoint":950,"contacts":11},"lstanbul Universitesi lstanbul Tip Fakultesi Hastanesi","Istanbul","34093",{"type":193,"coordinates":947},[948,949],28.94966,41.01384,{"lat":949,"lon":948},{"facility":952,"status":186,"city":953,"state":11,"zip":954,"country":936,"countryCode":11,"cosmosGeoPoint":955,"geoPoint":959,"contacts":11},"Mersin VM Medikal Park Hastanesi","Mersin","33200",{"type":193,"coordinates":956},[957,958],34.63886,36.81196,{"lat":958,"lon":957},{"facility":961,"status":186,"city":962,"state":963,"zip":964,"country":965,"countryCode":966,"cosmosGeoPoint":967,"geoPoint":971,"contacts":11},"University Hospital of Wales","Cardiff","Wales","CF14 4XW","United Kingdom","UK",{"type":193,"coordinates":968},[969,970],-3.18,51.48,{"lat":970,"lon":969},{"facility":973,"status":186,"city":187,"state":11,"zip":974,"country":965,"countryCode":966,"cosmosGeoPoint":975,"geoPoint":979,"contacts":11},"Queen Elizabeth Hospital, University Hospital Birmingham","B15 2GW",{"type":193,"coordinates":976},[977,978],-1.89983,52.48142,{"lat":978,"lon":977},{"facility":981,"status":186,"city":982,"state":11,"zip":983,"country":965,"countryCode":966,"cosmosGeoPoint":984,"geoPoint":988,"contacts":11},"University College London Hospitals (UCLH), Haematology Cancer Clinical Trials Unit","London","NW1 2PG",{"type":193,"coordinates":985},[986,987],-0.12574,51.50853,{"lat":987,"lon":986},{"facility":990,"status":186,"city":982,"state":11,"zip":991,"country":965,"countryCode":966,"cosmosGeoPoint":992,"geoPoint":994,"contacts":11},"Guy's and St Thomas's NHS Foundation Trust","SE1 7EH",{"type":193,"coordinates":993},[986,987],{"lat":987,"lon":986},{"facility":996,"status":186,"city":997,"state":11,"zip":998,"country":965,"countryCode":966,"cosmosGeoPoint":999,"geoPoint":1003,"contacts":11},"GenesisCare","Oxford","OX4 6LB",{"type":193,"coordinates":1000},[1001,1002],-1.25596,51.75222,{"lat":1002,"lon":1001},{"facility":1005,"status":186,"city":1006,"state":11,"zip":1007,"country":965,"countryCode":966,"cosmosGeoPoint":1008,"geoPoint":1012,"contacts":11},"University Hospital Plymouth Trust - Derriford Hospital","Plymouth","PL6 8DH",{"type":193,"coordinates":1009},[1010,1011],-4.14305,50.37153,{"lat":1011,"lon":1010},{"type":1014,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100432405","phase-2-harbor-study-to-evaluate-efficacy-and-safety-of-blu-263-versus-placebo-in-patients-with-indolent-systemic-mastocytosis-100432405",false,"NCT04910685","(HARBOR) Study to Evaluate Efficacy and Safety of BLU-263 Versus Placebo in Patients With Indolent Systemic Mastocytosis","A Randomized, Double-Blind, Placebo-Controlled Phase 2\u002F3 Study of BLU-263 in Indolent Systemic Mastocytosis","Key Inclusion Criteria:\n\nAll Participants:\n\n-Participant must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.\n\nPart 1 and PK groups:\n\n* Participant has confirmed diagnosis of ISM, confirmed by Central Pathology Review\n* Participant must have failed to achieve adequate symptom control for 1 or more Baseline symptoms, as determined by the Investigator, with at least 2 of the following symptom-directed therapies administered: H1 blockers, H2 blockers, proton-pump inhibitors, leukotriene inhibitors, cromolyn sodium, corticosteroids, or omalizumab.\n* Participants must have SDT for ISM symptom management stabilized for at least 14 days prior to starting screening procedures.\n* For participants receiving corticosteroids, the dose must be ≤ 20 mg\u002Fday prednisone or equivalent, and the dose must be stable for ≥ 14 days.\n\nPart K:\n\n-Participant has confirmed diagnosis of ISM, confirmed by Central Pathology Review\n\nPart S:\n\n-Participant has confirmed diagnosis of SSM, confirmed by Central Pathology Review of BM biopsy and central review of B- and C-findings by WHO diagnostic criteria.\n\nPart 2:\n\n-Participant has confirmed diagnosis of ISM, confirmed by Central Pathology Review\n\nKey Exclusion Criteria:\n\n* Participant has been diagnosed with any of the following WHO systemic mastocytosis (SM) sub-classifications: cutaneous mastocytosis only, SM with an associated hematologic neoplasm of non-MC lineage (SM-AHN), aggressive SM, mast cell leukemia, or mast cell sarcoma.\n* Participant has been diagnosed with another myeloproliferative disorder.\n* Participant has organ damage attributable to SM.\n* Participant has clinically significant, uncontrolled, cardiovascular disease\n* Participant has a QT interval corrected using Fridericia's formula (QTcF) \\> \\> 470 milliseconds (msec) (for females) or \\> 450 msec (for males).\n* Participant has a history of a primary malignancy that has been diagnosed or required therapy within 3 years. The following prior malignancies are not exclusionary: completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate cancer, and completely resected carcinoma in situ of any site.\n* Time since any cytoreductive therapy including masitinib and midostaurin should be at least 5 half-lives or 14 days (whichever is longer), and for cladribine, interferon alpha, pegylated interferon, or antibody therapy \\\u003C 28 days or 5 half-lives of the drug (whichever is longer), before beginning the screening period.\n* Participant has received radiotherapy or psoralen and ultraviolet A (PUVA) therapy \\\u003C 14 days before beginning the screening period.\n\nOther protocol-defined criteria apply.","ALL","18 Years",{"count":1025,"type":1026},534,"ESTIMATED","INTERVENTIONAL",[1029,1030],"PHASE2","PHASE3","This is a randomized, double-blind, placebo-controlled, Phase 2\u002F3 study comparing the efficacy and safety of elenestinib (BLU-263) + symptom directed therapy (SDT) with placebo + SDT in participants with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by SDT. Parts 1 and 2 will enroll participants with ISM. Participants enrolled in Part 2 will roll over onto Part 3 to receive treatment with elenestinib in an open-label fashion following completion of the earlier Part. Part K will enroll participants with ISM who have previously received an approved selective KIT inhibitor. The study also includes pharmacokinetic (PK) groups that will enroll participants with ISM.",[1033,1034],"Indolent Systemic Mastocytosis","Smoldering Systemic Mastocytosis",[1036,1037],"ISM","SSM","2026-10-05",{"date":1040,"type":1041},"2026-10-07","ACTUAL",{"date":1043,"type":1041},"2021-11-30",{"date":1045,"type":1026},"2032-09-30",{"name":5,"class":6},88]