[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07725380":3,"trial-entities:NCT07725380":169,"trial-summary:NCT07725380":172},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":54,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":93,"locations":96,"central_contacts":157,"overall_officials":163,"references":167,"see_also_links":168},"NCT07725380","MCC-23906","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","RECRUITING","2031-08","2026-07","2026-07-24","2026-07-15","H. Lee Moffitt Cancer Center and Research Institute","OTHER",true,"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.",null,[19,20],"Sarcoma","Osteosarcoma",[],"INTERVENTIONAL","TREATMENT",[25,26],"PHASE1","PHASE2",{"count":28,"type":29},74,"ESTIMATED",[31,39],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Domatinostat","Tablet",[36,37,38],"Phase 1 Dose Escalation Cohort","Phase 2 Arm A (Surgical Complete Remission Osteosarcoma)","Phase 2 Arm B (Measurable Osteosarcoma)",{"type":32,"name":40,"description":34,"armGroupLabels":41},"Sirolimus",[36,37,38],[43,47,51],{"measure":44,"description":45,"timeFrame":46},"Phase 1: Maximum Tolerated Dose (MTD)","For the phase 1 portion, a standard 3+3 design will be used to determine the MTD and\u002For RP2D for the Phase 2 portion of this study.","28 days",{"measure":48,"description":49,"timeFrame":50},"Phase 2: Arm A Event Free Surival","Event free survival (EFS) is defined as the duration of time from start of treatment to time of disease progression, secondary malignancy, or death, whichever occurs first.","12 months",{"measure":52,"description":49,"timeFrame":53},"Phase 2: Arm B Event Free Surival","4 months",[55],{"measure":56,"description":57,"timeFrame":58},"Phase 2: Overall Survival","Overall Survival (OS) of phase 2 participants.","Up to 5 years","ALL","12 Years","40 Years",false,{"inclusion":64,"exclusion":76,"raw_text":92},[65,66,67,68,69,70,71,72,73,74,75],"Age ≥12 and ≤40 years.","Histologically confirmed relapsed or refractory sarcoma (Phase 1) or osteosarcoma (Phase 2).","At least one prior standard systemic therapy regimen.","Not candidates for available therapies known to provide survival benefit.","Karnofsky\u002FLansky performance score ≥60.","Life expectancy ≥16 weeks.","Adequate organ function: ANC ≥1,000\u002FmcL, Platelets ≥100,000\u002FuL, Hemoglobin ≥8 g\u002FdL, Adequate hepatic and renal function.","Ability to swallow tablets.","Negative pregnancy test for females of childbearing potential.","Agreement to use effective contraception.","Ability to provide informed consent\u002Fassent.",[77,78,79,80,81,82,83,84,85,86,87,88,89,90,91],"Receiving another investigational agent.","Receiving concurrent anticancer therapy.","Known hypersensitivity to domatinostat or sirolimus.","Bone marrow-only disease.","CNS metastatic disease.","Major surgery within 2 weeks prior to treatment.","Active malignancy within the previous 3 years (with protocol-specified exceptions).","History of solid organ transplantation.","Significant recent cardiac disease.","Concurrent prohibited CYP3A4\u002FP-gp interacting medications.","Uncontrolled infection or other serious uncontrolled illness.","Pregnancy or breastfeeding.","HIV infection on antiretroviral therapy.","Weight \\\u003C40 kg.","Inability to comply with study requirements.","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.",[94,95],"CHILD","ADULT",[97,123,135,146],{"facility":98,"status":8,"city":99,"state":100,"zip":101,"country":102,"contacts":103,"geoPoint":120},"Moffitt Cancer Center","Tampa","Florida","33612","United States",[104,107,110,112,114,116,118],{"name":105,"role":106},"Jonathan Metts, MD","PRINCIPAL_INVESTIGATOR",{"name":108,"role":109},"Andrew Brohl, MD","SUB_INVESTIGATOR",{"name":111,"role":109},"Isabel Canizares, APRN",{"name":113,"role":109},"Mihaela Druta, MD",{"name":115,"role":109},"Anya Ibern, APRN",{"name":117,"role":109},"Desiree Morales, APRN",{"name":119,"role":109},"Mauricio Silva Almeida Ribeiro, MD",{"lat":121,"lon":122},27.94752,-82.45843,{"facility":124,"status":125,"city":126,"state":127,"zip":128,"country":102,"contacts":129,"geoPoint":132},"Washington University in St. Louis","NOT_YET_RECRUITING","St Louis","Missouri","63110",[130],{"name":131,"role":106},"Amy Armstrong, MD",{"lat":133,"lon":134},38.62727,-90.19789,{"facility":136,"status":125,"city":137,"state":138,"zip":139,"country":102,"contacts":140,"geoPoint":143},"Montefiore Medical Center","The Bronx","New York","10467",[141],{"name":142,"role":106},"Alice Lee, MD",{"lat":144,"lon":145},40.84985,-73.86641,{"facility":147,"status":125,"city":148,"state":149,"zip":150,"country":102,"contacts":151,"geoPoint":154},"Nationwide Children's Hospital","Columbus","Ohio","43205",[152],{"name":153,"role":106},"Bhuvana Setty, MD",{"lat":155,"lon":156},39.96118,-82.99879,[158],{"name":159,"role":160,"phone":161,"email":162},"Jessica Crimella","CONTACT","813-745-6250","Jessica.Crimella@moffitt.org",[164,166],{"name":131,"affiliation":165,"role":106},"Washington University School of Medicine",{"name":105,"affiliation":98,"role":106},[],[],{"nct_id":4,"conditions":170,"biomarkers":171},[20,19],[],{"nct_id":4,"found":15,"summary":173,"prompt_version":183},{"design":174,"status":175,"heading":176,"summary":177,"follow_up":178,"word_count":179,"commitments":180,"compensation":181,"drugs_mentioned":182},"This is a Phase 1\u002F2, open-label study, meaning both you and your doctors will know which treatments you are receiving. It plans to enroll 74 participants.","completed","Domatinostat with Sirolimus for Relapsed or Refractory Sarcoma and Osteosarcoma","This study is testing a combination of two drugs, domatinostat and sirolimus, for adolescents and young adults (ages 12-40) with sarcoma or osteosarcoma that has come back or not responded to previous treatments. Researchers want to understand if this drug combination is safe, how well your body handles it, and if it can help shrink tumors. The study will measure the highest safe dose of the drugs (Phase 1) and how long people live without their cancer getting worse (Event Free Survival) for up to 12 months (Phase 2). This study is currently unclear on its recruitment status.","The study will track how long participants live without their cancer getting worse for up to 12 months in one group and up to 4 months in another group.",98,"Not specified in the trial record.","Not stated in the trial record.",[33,40],"v2"]