[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100403588":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":27,"locations":36,"responsibleParty":55,"collaborators":31,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":31,"enrollmentInfo":67,"targetDuration":31,"studyType":70,"phases":71,"briefSummary":18,"conditions":73,"keywords":31,"overallStatus":39,"whyStopped":31,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Sarcoma Oncology Research Center, LLC","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single arm","EXPERIMENTAL","Trabectedin 24 h CIV 0.5 mg\u002Fm2 D1 and D8 Gemcitabine i.v. 250 mg\u002Fm2 D1 and D8 Dacarbazine i.v. 250 mg\u002Fm2 D1 and D8",[13],"Drug: Trabectedin",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Trabectedin","This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.",[9],[21,22],"Gemcitabine","Dacarbazine",[24],{"name":25,"affiliation":5,"role":26},"Sant P Chawla, MD","PRINCIPAL_INVESTIGATOR",[28,33],{"name":25,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","3105529999",null,"santchawla@sarcomaoncology.com",{"name":34,"role":29,"phone":30,"phoneExt":31,"email":35},"Victoria Chua-Alcala, MD","vchua@sarcomaoncology.com",[37],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Sant P Chawla","RECRUITING","Santa Monica","California","90403","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-118.49138,34.01949,{"lat":49,"lon":48},[52,54],{"name":25,"role":29,"phone":53,"phoneExt":31,"email":32},"310-552-9999",{"name":34,"role":29,"phone":30,"phoneExt":31,"email":35},{"type":56,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100403588","phase-2-metronomic-trabectedin-gemcitabine-and-dacarbazine-for-soft-tissue-sarcoma-100403588",false,"NCT04535271","Metronomic Trabectedin, Gemcitabine, and Dacarbazine for Soft Tissue Sarcoma","TAGGED: A Phase 2 Study Using Low Dose\u002FMetronomic Trabectedin, Gemcitabine, and Dacarbazine as 2nd\u002F3rd\u002F4th Line Therapy for Advanced Soft Tissue Sarcoma","TAGGED","Inclusion Criteria:\n\n* Male or Female ≥ 18 years of age\n* Pathologically confirmed diagnosis of locally advanced, unresectable or metastatic leiomyosarcoma\n* Previously treated patient with measurable disease by RECIST v1.1\n* ECOG performance status ≤ 2\n* Life expectancy of at least 3 months\n* Acceptable liver function: Bilirubin \\\u003C 1.5 times upper limit of normal (ULN; except subjects with Gilbert Syndrome who must have a total bilirubin level \\\u003C 3.0 ULN); AST (SGOT), ALT (SGPT) and alk phos \\\u003C 2.5 x ULN (\\\u003C 5 x ULN if liver metastases present)\n* Acceptable renal function: Creatinine \\\u003C 1.5 times ULN and creatinine clearance \\> 60 ml\u002Fmin using the Crockroft-Gault formula\n* Acceptable hematologic status: ANC \\>1000 cells\u002FμL; Platelet count \\>100,000\u002FμL; Hemoglobin \\> 9.0 g\u002FdL\n* INR and PT \\\u003C 1.5 ULN unless taking anti-coagulation, in which case PT, INR and aPTT must be within therapeutic range of intended use of anticoagulants\n* Ability to understand the purposes and risks of the study and has signed and dated a written informed consent form approved by the Investigator's IRB\u002FEthics Committee\n* Willingness to comply with all study procedures and availability for the duration of the study\n* All women of childbearing potential must have a negative urine or serum pregnancy test within 72 hours of enrollment. If urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required; all subjects must agree to use highly effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 5 months for women and 7 months for men after the last dose.\n\nExclusion Criteria:\n\n* Currently receiving treatment with another investigational device or drug study, or \\\u003C14 days since ending treatment with another investigational device or drug study(s).\n* Subject has known sensitivity to trabectedin, gemcitabine or dacarbazine.\n* Female subject is pregnant or breast-feeding or planning to become pregnant during study treatment and through 3 months after the last dose of trabectedin, gemcitabine or dacarbazine.\n* Female subject of childbearing potential who is unwilling to use acceptable method(s) of effective contraception during study treatment and through 3 months after the last dose of trabectedin, gemcitabine or dacarbazine.\n* Sexually active subjects and their partners unwilling to use male or female latex condom","ALL","18 Years",{"count":68,"type":69},80,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2",[74],"Leiomyosarcoma","2025-02-21",{"date":77,"type":78},"2025-02-24","ACTUAL",{"date":80,"type":78},"2021-09-09",{"date":82,"type":69},"2029-03-30",{"name":5,"class":6},1]