[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04535271":3,"trial-entities:NCT04535271":111,"trial-summary:NCT04535271":114},{"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":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":37,"secondary_outcomes":42,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":15,"eligibility_criteria":53,"std_ages":74,"locations":77,"central_contacts":97,"overall_officials":100,"references":103,"see_also_links":110},"NCT04535271","SOC-2101","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","RECRUITING","2029-03-30","2025-02","2025-02-24","2021-09-09","Sarcoma Oncology Research Center, LLC","OTHER",false,"This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.","This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.\n\nA total of 80 patients will receive trabectedin 0.5 mg\u002Fm2 as 24 hour continuous intravenous infusion (CIV) on D1 and D8, gemcitabine 200 mg\u002Fm2 i.v. on D1 and D8, and dacarbazine 200 mg\u002Fm2 i.v. on D1 and D8 (see product information; www.accessdata.fda.gov). Treatment cycles are given every 3 weeks. Patients in this study may continue treatment until significant disease progression or unacceptable toxicity occurs up to one year of therapy. Patients who withdraw or do not complete the first 2 treatment cycles and first follow up CT scan\u002FMRI will be replaced.",[19],"Leiomyosarcoma",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},80,"ESTIMATED",[29],{"type":30,"name":31,"description":16,"armGroupLabels":32,"otherNames":34},"DRUG","Trabectedin",[33],"Single arm",[35,36],"Gemcitabine","Dacarbazine",[38],{"measure":39,"description":40,"timeFrame":41},"Progression free survival","Progression free survival up to disease progression or death from any cause","12 months",[43,47],{"measure":44,"description":45,"timeFrame":46},"Overall Response","Best overall response (BOR) and duration of response (DOR) by RECIST v1.1 via CT scan or MRI","6 weeks",{"measure":48,"description":49,"timeFrame":41},"Adverse Event","Incidence of treatment-related adverse events","ALL","18 Years",null,{"inclusion":54,"exclusion":67,"raw_text":73},[55,56,57,58,59,60,61,62,63,64,65,66],"Male or Female ≥ 18 years of age","Pathologically confirmed diagnosis of locally advanced, unresectable or metastatic leiomyosarcoma","Previously treated patient with measurable disease by RECIST v1.1","ECOG performance status ≤ 2","Life expectancy of at least 3 months","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)","Acceptable renal function: Creatinine \\\u003C 1.5 times ULN and creatinine clearance \\> 60 ml\u002Fmin using the Crockroft-Gault formula","Acceptable hematologic status: ANC \\>1000 cells\u002FμL; Platelet count \\>100,000\u002FμL; Hemoglobin \\> 9.0 g\u002FdL","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","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","Willingness to comply with all study procedures and availability for the duration of the study","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.",[68,69,70,71,72],"Currently receiving treatment with another investigational device or drug study, or \\\u003C14 days since ending treatment with another investigational device or drug study(s).","Subject has known sensitivity to trabectedin, gemcitabine or dacarbazine.","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.","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.","Sexually active subjects and their partners unwilling to use male or female latex condom","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",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":79,"status":8,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":94},"Sant P Chawla","Santa Monica","California","90403","United States",[85,90],{"name":86,"role":87,"phone":88,"email":89},"Sant P Chawla, MD","CONTACT","310-552-9999","santchawla@sarcomaoncology.com",{"name":91,"role":87,"phone":92,"email":93},"Victoria Chua-Alcala, MD","3105529999","vchua@sarcomaoncology.com",{"lat":95,"lon":96},34.01949,-118.49138,[98,99],{"name":86,"role":87,"phone":92,"email":89},{"name":91,"role":87,"phone":92,"email":93},[101],{"name":86,"affiliation":13,"role":102},"PRINCIPAL_INVESTIGATOR",[104,108],{"pmid":105,"type":106,"citation":107},"25210398","BACKGROUND","Maiti R. Metronomic chemotherapy. J Pharmacol Pharmacother. 2014 Jul;5(3):186-92. doi: 10.4103\u002F0976-500X.136098.",{"type":106,"citation":109},"www.accessdata.fda.gov\u002Fdrugsatfda_docs (Trabectedin, Gemcitabine, Dacarbazine)",[],{"nct_id":4,"conditions":112,"biomarkers":113},[19],[],{"nct_id":4,"found":115,"summary":116,"prompt_version":126},true,{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is an open-label, Phase 2 study involving 80 participants. All participants will receive the same combination of medications.","completed","Phase 2 Study for Leiomyosarcoma Treatment","This study is testing a combination of three medications – Trabectedin, Gemcitabine, and Dacarbazine – for people with leiomyosarcoma, a type of soft tissue sarcoma. These drugs are given intravenously (into a vein) in a specific way called \"metronomic dosing.\" The study is looking to see how long patients live without their cancer getting worse (progression-free survival) at 12 months. You may be able to join if you are at least 18 years old, have leiomyosarcoma that has spread or cannot be removed, and have already received treatment for it. The study aims to enroll 80 participants. The current status of this study is unclear.","The primary endpoint, progression-free survival, is measured at 12 months. Patients may continue treatment for up to one year.",105,"You would receive Trabectedin, Gemcitabine, and Dacarbazine intravenously on Day 1 and Day 8 of a 3-week cycle. Treatment may continue for up to one year, or until your disease progresses significantly or side effects become too severe.","Not stated in the trial record.",[31],"v2"]