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(Türkiye)",{"type":76,"coordinates":681},[682,683],28.94966,41.01384,{"lat":683,"lon":682},{"facility":686,"status":69,"city":687,"state":59,"zip":688,"country":679,"countryCode":59,"cosmosGeoPoint":689,"geoPoint":693,"contacts":59},"Mersin VM Medikal Park Hastanesi","Mersin","33200",{"type":76,"coordinates":690},[691,692],34.63886,36.81196,{"lat":692,"lon":691},{"facility":695,"status":69,"city":696,"state":697,"zip":698,"country":699,"countryCode":700,"cosmosGeoPoint":701,"geoPoint":705,"contacts":59},"University Hospital of Wales","Cardiff","Wales","CF14 4XW","United Kingdom","UK",{"type":76,"coordinates":702},[703,704],-3.18,51.48,{"lat":704,"lon":703},{"facility":695,"status":69,"city":696,"state":59,"zip":698,"country":699,"countryCode":700,"cosmosGeoPoint":707,"geoPoint":709,"contacts":59},{"type":76,"coordinates":708},[703,704],{"lat":704,"lon":703},{"facility":711,"status":69,"city":712,"state":59,"zip":713,"country":699,"countryCode":700,"cosmosGeoPoint":714,"geoPoint":718,"contacts":59},"University College London Hospitals (UCLH), Haematology Cancer Clinical Trials Unit","London","NW1 2PG",{"type":76,"coordinates":715},[716,717],-0.12574,51.50853,{"lat":717,"lon":716},{"facility":720,"status":69,"city":712,"state":59,"zip":721,"country":699,"countryCode":700,"cosmosGeoPoint":722,"geoPoint":724,"contacts":59},"Guy's and St Thomas's NHS Foundation Trust","SE1 7EH",{"type":76,"coordinates":723},[716,717],{"lat":717,"lon":716},{"facility":726,"status":69,"city":727,"state":59,"zip":728,"country":699,"countryCode":700,"cosmosGeoPoint":729,"geoPoint":733,"contacts":59},"Cancer and Haematology Centre","Oxford","OX3 7LE",{"type":76,"coordinates":730},[731,732],-1.25596,51.75222,{"lat":732,"lon":731},{"facility":735,"status":69,"city":736,"state":59,"zip":737,"country":699,"countryCode":700,"cosmosGeoPoint":738,"geoPoint":742,"contacts":59},"University Hospital Plymouth NHS Trust","Plymouth","PL6 8DH",{"type":76,"coordinates":739},[740,741],-4.14305,50.37153,{"lat":741,"lon":740},{"type":744,"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":755,"type":756},534,"ESTIMATED","INTERVENTIONAL",[759,760],"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.",[763,764],"Indolent Systemic Mastocytosis","Smoldering Systemic Mastocytosis",[766,767],"ISM","SSM","2026-06-23",{"date":770,"type":771},"2026-06-25","ACTUAL",{"date":773,"type":771},"2021-11-30",{"date":775,"type":756},"2032-09-30",{"name":5,"class":6},71]