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Basel","Basel","C-4031","Switzerland","CH",{"type":76,"coordinates":691},[692,693],7.57327,47.55839,{"lat":693,"lon":692},{"facility":696,"status":69,"city":697,"state":59,"zip":698,"country":688,"countryCode":689,"cosmosGeoPoint":699,"geoPoint":703,"contacts":59},"Luzerner Kantonsspital","Lucerne","6000",{"type":76,"coordinates":700},[701,702],8.30635,47.05048,{"lat":702,"lon":701},{"facility":705,"status":69,"city":706,"state":59,"zip":707,"country":708,"countryCode":59,"cosmosGeoPoint":709,"geoPoint":713,"contacts":59},"Ankara Universitesi Tip Fakultesi Cebeci Hastanesi","Ankara","06620","Turkey (Türkiye)",{"type":76,"coordinates":710},[711,712],32.85427,39.91987,{"lat":712,"lon":711},{"facility":715,"status":69,"city":716,"state":59,"zip":717,"country":708,"countryCode":59,"cosmosGeoPoint":718,"geoPoint":722,"contacts":59},"lstanbul Universitesi lstanbul Tip Fakultesi Hastanesi","Istanbul","34093",{"type":76,"coordinates":719},[720,721],28.94966,41.01384,{"lat":721,"lon":720},{"facility":724,"status":69,"city":725,"state":59,"zip":726,"country":708,"countryCode":59,"cosmosGeoPoint":727,"geoPoint":731,"contacts":59},"Mersin VM Medikal Park Hastanesi","Mersin","33200",{"type":76,"coordinates":728},[729,730],34.63886,36.81196,{"lat":730,"lon":729},{"facility":733,"status":69,"city":734,"state":735,"zip":736,"country":737,"countryCode":738,"cosmosGeoPoint":739,"geoPoint":743,"contacts":59},"University Hospital of Wales","Cardiff","Wales","CF14 4XW","United Kingdom","UK",{"type":76,"coordinates":740},[741,742],-3.18,51.48,{"lat":742,"lon":741},{"facility":733,"status":69,"city":734,"state":59,"zip":736,"country":737,"countryCode":738,"cosmosGeoPoint":745,"geoPoint":747,"contacts":59},{"type":76,"coordinates":746},[741,742],{"lat":742,"lon":741},{"facility":749,"status":69,"city":750,"state":59,"zip":751,"country":737,"countryCode":738,"cosmosGeoPoint":752,"geoPoint":756,"contacts":59},"University College London Hospitals (UCLH), Haematology Cancer Clinical Trials Unit","London","NW1 2PG",{"type":76,"coordinates":753},[754,755],-0.12574,51.50853,{"lat":755,"lon":754},{"facility":758,"status":69,"city":750,"state":59,"zip":759,"country":737,"countryCode":738,"cosmosGeoPoint":760,"geoPoint":762,"contacts":59},"Guy's and St Thomas's NHS Foundation Trust","SE1 7EH",{"type":76,"coordinates":761},[754,755],{"lat":755,"lon":754},{"facility":764,"status":69,"city":765,"state":59,"zip":766,"country":737,"countryCode":738,"cosmosGeoPoint":767,"geoPoint":771,"contacts":59},"Cancer and Haematology Centre","Oxford","OX3 7LE",{"type":76,"coordinates":768},[769,770],-1.25596,51.75222,{"lat":770,"lon":769},{"facility":773,"status":69,"city":774,"state":59,"zip":775,"country":737,"countryCode":738,"cosmosGeoPoint":776,"geoPoint":780,"contacts":59},"University Hospital Plymouth NHS Trust","Plymouth","PL6 8DH",{"type":76,"coordinates":777},[778,779],-4.14305,50.37153,{"lat":779,"lon":778},{"type":782,"investigatorFullName":59,"investigatorTitle":59,"investigatorAffiliation":59,"oldNameTitle":59,"oldOrganization":59},"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":793,"type":794},534,"ESTIMATED","INTERVENTIONAL",[797,798],"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.",[801,802],"Indolent Systemic Mastocytosis","Smoldering Systemic Mastocytosis",[804,805],"ISM","SSM","2026-08-03",{"date":808,"type":809},"2026-08-04","ACTUAL",{"date":811,"type":809},"2021-11-30",{"date":813,"type":794},"2032-09-30",{"name":5,"class":6},75]