[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648719":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":33,"centralContacts":41,"locations":47,"responsibleParty":115,"collaborators":117,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":29,"eligibilityCriteria":129,"healthyVolunteers":125,"sex":130,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":29,"studyType":136,"phases":137,"briefSummary":140,"conditions":141,"keywords":29,"overallStatus":49,"whyStopped":29,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"H. Lee Moffitt Cancer Center and Research Institute","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1 Dose Escalation Cohort","EXPERIMENTAL","Participants with relapsed or refractory sarcoma will receive domatinostat plus sirolimus. Domatinostat dose levels will be escalated to determine the MTD and\u002For RP2D.",[13,14],"Drug: Domatinostat","Drug: Sirolimus",{"label":16,"type":10,"description":17,"interventionNames":18},"Phase 2 Arm A (Surgical Complete Remission Osteosarcoma)","Patients with relapsed\u002Frefractory osteosarcoma who achieve complete surgical remission before enrollment will receive domatinostat plus sirolimus at the RP2D.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Phase 2 Arm B (Measurable Osteosarcoma)","Patients with unresectable measurable relapsed\u002Frefractory osteosarcoma will receive domatinostat plus sirolimus at the RP2D.",[13,14],[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Domatinostat","Tablet",[9,16,20],null,{"type":25,"name":31,"description":27,"armGroupLabels":32,"otherNames":29},"Sirolimus",[9,16,20],[34,38],{"name":35,"affiliation":36,"role":37},"Amy Armstrong, MD","Washington University School of Medicine","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":40,"role":37},"Jonathan Metts, MD","Moffitt Cancer Center",[42],{"name":43,"role":44,"phone":45,"phoneExt":29,"email":46},"Jessica Crimella","CONTACT","813-745-6250","Jessica.Crimella@moffitt.org",[48,76,89,102],{"facility":40,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Tampa","Florida","33612","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-82.45843,27.94752,{"lat":59,"lon":58},[62,63,66,68,70,72,74],{"name":39,"role":37,"phone":29,"phoneExt":29,"email":29},{"name":64,"role":65,"phone":29,"phoneExt":29,"email":29},"Andrew Brohl, MD","SUB_INVESTIGATOR",{"name":67,"role":65,"phone":29,"phoneExt":29,"email":29},"Isabel Canizares, APRN",{"name":69,"role":65,"phone":29,"phoneExt":29,"email":29},"Mihaela Druta, MD",{"name":71,"role":65,"phone":29,"phoneExt":29,"email":29},"Anya Ibern, APRN",{"name":73,"role":65,"phone":29,"phoneExt":29,"email":29},"Desiree Morales, APRN",{"name":75,"role":65,"phone":29,"phoneExt":29,"email":29},"Mauricio Silva Almeida Ribeiro, MD",{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":53,"countryCode":54,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Washington University in St. Louis","NOT_YET_RECRUITING","St Louis","Missouri","63110",{"type":56,"coordinates":83},[84,85],-90.19789,38.62727,{"lat":85,"lon":84},[88],{"name":35,"role":37,"phone":29,"phoneExt":29,"email":29},{"facility":90,"status":78,"city":91,"state":92,"zip":93,"country":53,"countryCode":54,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Montefiore Medical Center","The Bronx","New York","10467",{"type":56,"coordinates":95},[96,97],-73.86641,40.84985,{"lat":97,"lon":96},[100],{"name":101,"role":37,"phone":29,"phoneExt":29,"email":29},"Alice Lee, MD",{"facility":103,"status":78,"city":104,"state":105,"zip":106,"country":53,"countryCode":54,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"Nationwide Children's Hospital","Columbus","Ohio","43205",{"type":56,"coordinates":108},[109,110],-82.99879,39.96118,{"lat":110,"lon":109},[113],{"name":114,"role":37,"phone":29,"phoneExt":29,"email":29},"Bhuvana Setty, MD",{"type":116,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[118,120],{"name":119,"class":6},"National Pediatric Cancer Foundation",{"name":121,"class":122},"Healx USA, Inc","UNKNOWN","100648719","phase-1-domatinostat-with-sirolimus-for-relapsed-refractory-sarcoma-and-osteosarcoma-100648719",false,"NCT07725380","Domatinostat With Sirolimus for Relapsed, Refractory Sarcoma and Osteosarcoma","Open-Label, Cohort-Sequential Dose-Escalation and Dose-Confirmation Phase 1\u002F2 Clinical Trial to Evaluate the Safety and Efficacy of Domatinostat in Combination With Sirolimus in Adolescents and Adults With Relapsed, Refractory Sarcoma and Osteosarcoma","Inclusion Criteria:\n\n* Age ≥12 and ≤40 years.\n* Histologically confirmed relapsed or refractory sarcoma (Phase 1) or osteosarcoma (Phase 2).\n* At least one prior standard systemic therapy regimen.\n* Not candidates for available therapies known to provide survival benefit.\n* Karnofsky\u002FLansky performance score ≥60.\n* Life expectancy ≥16 weeks.\n* Adequate organ function: ANC ≥1,000\u002FmcL, Platelets ≥100,000\u002FuL, Hemoglobin ≥8 g\u002FdL, Adequate hepatic and renal function.\n* Ability to swallow tablets.\n* Negative pregnancy test for females of childbearing potential.\n* Agreement to use effective contraception.\n* Ability to provide informed consent\u002Fassent.\n\nExclusion Criteria:\n\n* Receiving another investigational agent.\n* Receiving concurrent anticancer therapy.\n* Known hypersensitivity to domatinostat or sirolimus.\n* Bone marrow-only disease.\n* CNS metastatic disease.\n* Major surgery within 2 weeks prior to treatment.\n* Active malignancy within the previous 3 years (with protocol-specified exceptions).\n* History of solid organ transplantation.\n* Significant recent cardiac disease.\n* Concurrent prohibited CYP3A4\u002FP-gp interacting medications.\n* Uncontrolled infection or other serious uncontrolled illness.\n* Pregnancy or breastfeeding.\n* HIV infection on antiretroviral therapy.\n* Weight \\\u003C40 kg.\n* Inability to comply with study requirements.","ALL","12 Years","40 Years",{"count":134,"type":135},74,"ESTIMATED","INTERVENTIONAL",[138,139],"PHASE1","PHASE2","This is a multicenter, open-label, Phase 1\u002F2 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of domatinostat in combination with sirolimus in adolescents and adults with relapsed or refractory sarcoma and osteosarcoma.",[142,143],"Sarcoma","Osteosarcoma","2026-07-21",{"date":146,"type":147},"2026-07-24","ACTUAL",{"date":149,"type":147},"2026-07-15",{"date":151,"type":135},"2031-08",{"name":5,"class":6},4]