[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524843":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":33,"locations":43,"responsibleParty":181,"collaborators":27,"id":183,"slug":184,"hasResults":185,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":185,"sex":191,"minAge":192,"maxAge":193,"enrollmentInfo":194,"targetDuration":27,"studyType":197,"phases":198,"briefSummary":200,"conditions":201,"keywords":27,"overallStatus":64,"whyStopped":27,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":212},{"fullName":5,"class":6},"Asociación Europea y Latinoamericana SELNET para la Investigación en Sarcomas","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"gemcitabine + selinexor:","EXPERIMENTAL","Selinexor will be given at 60 mg once per week orally days 1, 8 and 15 every 21 days\n\nGemcitabine will be given at the dose 1200 mg\u002Fm2 (10 mg\u002Fm2\u002Fmin) days 1 and 8 every 21 days",[13,14],"Drug: Selinexor 20 MG","Drug: Gemcitabine",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Selinexor 20 MG","After having completed the Phase I part, the recommended dose for Phase II is 60mg Selinexor",[9],[22],"KPT-330",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Gemcitabine","Gemcitabine will be given at the dose 1200 mg\u002Fm2 (10 mg\u002Fm2\u002Fmin) days 1 and 8 every 21 days.",[9],null,[29],{"name":30,"affiliation":31,"role":32},"Javier MD Martín Broto","Hospital Universitario Fundación Jiménez Díaz","STUDY_DIRECTOR",[34,40],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Patricio Ledesma","CONTACT","971 439 900","+34","ensayos@sofpromed.com",{"name":41,"role":36,"phone":37,"phoneExt":38,"email":42},"Inés Torrens","itorrens@sofpromed.com",[44,62,76,86,99,112,122,132,142,155,168],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Hospital Universitario de Canarias","NOT_YET_RECRUITING","Santa Cruz de Tenerife","Canary Islands","38320","Spain","ES",{"type":53,"coordinates":54},"Point",[55,56],-16.25462,28.46824,{"lat":56,"lon":55},[59],{"name":60,"role":36,"phone":27,"phoneExt":27,"email":61},"Josefina MD Cruz","jcruzjurado@gmail.com",{"facility":63,"status":64,"city":65,"state":27,"zip":66,"country":50,"countryCode":51,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Hospital de la Santa Creu i Sant Pau","RECRUITING","Barcelona","08025",{"type":53,"coordinates":68},[69,70],2.15899,41.38879,{"lat":70,"lon":69},[73],{"name":74,"role":36,"phone":27,"phoneExt":27,"email":75},"Ana MD Sebio","ASebio@santpau.cat",{"facility":77,"status":64,"city":65,"state":27,"zip":78,"country":50,"countryCode":51,"cosmosGeoPoint":79,"geoPoint":81,"contacts":82},"Hospital Universitario Vall d'Hebron","08035",{"type":53,"coordinates":80},[69,70],{"lat":70,"lon":69},[83],{"name":84,"role":36,"phone":27,"phoneExt":27,"email":85},"Claudia MD Valverde","cmvalver@vhebron.net",{"facility":87,"status":46,"city":88,"state":27,"zip":89,"country":50,"countryCode":51,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Hospital Universitario de Donostia","Donostia \u002F San Sebastian","20014",{"type":53,"coordinates":91},[92,93],-1.97499,43.31283,{"lat":93,"lon":92},[96],{"name":97,"role":36,"phone":27,"phoneExt":27,"email":98},"Ana MD Paisán","ana.paisanruiz@osakidetza.eus",{"facility":100,"status":46,"city":101,"state":27,"zip":102,"country":50,"countryCode":51,"cosmosGeoPoint":103,"geoPoint":107,"contacts":108},"Hospital General Universitario Gregorio Marañón","Madrid","28009",{"type":53,"coordinates":104},[105,106],-3.70256,40.4165,{"lat":106,"lon":105},[109],{"name":110,"role":36,"phone":27,"phoneExt":27,"email":111},"Rosa MD Álvarez","rosa.alvarez.al@gmail.com",{"facility":113,"status":64,"city":101,"state":27,"zip":114,"country":50,"countryCode":51,"cosmosGeoPoint":115,"geoPoint":117,"contacts":118},"Hospital Clínico San Carlos","28040",{"type":53,"coordinates":116},[105,106],{"lat":106,"lon":105},[119],{"name":120,"role":36,"phone":27,"phoneExt":27,"email":121},"Antonio MD Casado","antoniocasado6@gmail.com",{"facility":31,"status":64,"city":101,"state":27,"zip":114,"country":50,"countryCode":51,"cosmosGeoPoint":123,"geoPoint":125,"contacts":126},{"type":53,"coordinates":124},[105,106],{"lat":106,"lon":105},[127,129],{"name":30,"role":36,"phone":27,"phoneExt":27,"email":128},"jmartin@atbsarc.org",{"name":130,"role":36,"phone":27,"phoneExt":27,"email":131},"Nadia Hindi","nhindi@atbsarc.org",{"facility":133,"status":64,"city":101,"state":27,"zip":134,"country":50,"countryCode":51,"cosmosGeoPoint":135,"geoPoint":137,"contacts":138},"Hospital Universitario La Paz","28046",{"type":53,"coordinates":136},[105,106],{"lat":106,"lon":105},[139],{"name":140,"role":36,"phone":27,"phoneExt":27,"email":141},"Andrés MD Redondo","aredondo12@gmail.com",{"facility":143,"status":46,"city":144,"state":27,"zip":145,"country":50,"countryCode":51,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Hospital Clínico Universitario Virgen de la Arrixaca","Murcia","30120",{"type":53,"coordinates":147},[148,149],-1.13004,37.98704,{"lat":149,"lon":148},[152],{"name":153,"role":36,"phone":27,"phoneExt":27,"email":154},"Jerónimo MD Martínez","jeronimo@seom.org",{"facility":156,"status":46,"city":157,"state":27,"zip":158,"country":50,"countryCode":51,"cosmosGeoPoint":159,"geoPoint":163,"contacts":164},"Hospital Clinico Universitario Valencia","Valencia","46010",{"type":53,"coordinates":160},[161,162],-0.37966,39.47391,{"lat":162,"lon":161},[165],{"name":166,"role":36,"phone":27,"phoneExt":27,"email":167},"Alejandro MD Pérez Fidalgo","japfidalgo@msn.com",{"facility":169,"status":64,"city":170,"state":27,"zip":171,"country":50,"countryCode":51,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Hospital Universitario Miguel Servet","Zaragoza","50009",{"type":53,"coordinates":173},[174,175],-0.87734,41.65606,{"lat":175,"lon":174},[178],{"name":179,"role":36,"phone":27,"phoneExt":27,"email":180},"Javier MD Martínez Trufero","jmtrufero@seom.org",{"type":182,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100524843","phase-2-selinexor-plus-gemcitabine-in-selected-advanced-soft-tissue-sarcoma-selisarc-100524843",false,"NCT06114004","Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcoma (SeliSarc)","Phase I\u002FII Randomized Clinical Trial of Selinexor Plus Gemcitabine in Selected Advanced Soft-tissue Sarcomas","SeliSarc","Inclusion Criteria:\n\n1. Patients must provide written informed consent prior to performance of any study-specific procedures and must be willing to comply with treatment and follow-up. Informed consent must be obtained prior to start of the screening process. Procedures conducted as part of the patient's routine clinical management (e.g. imaging tests), obtained prior to signature of informed consent may be used for screening or baseline purposes as long as these procedures are conducted as specified in the protocol.\n2. Age: 18-80 years.\n3. Histologic diagnosis of soft tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) confirmed by central pathology review prior to enrolment with an archive tumor sample. A fresh paraffin embedded tumor tissue block must be provided for all subjects for biomarker analysis before and (when feasible) after treatment with investigational products.\n4. Metastatic\u002Fadvanced disease in progression in the last 6 months.\n5. Patients have previously received at least one previous line of systemic therapy.\n6. Measurable disease according to RECIST 1.1 criteria.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.\n8. Adequate hepatic, renal, cardiac, and hematologic function.\n9. Laboratory tests as follows:\n\n   * Absolute neutrophil count ≥ 1,500\u002Fmm³\n   * Platelet count ≥ 100,000\u002Fmm³\n   * Bilirubin ≤ 1.5 mg\u002FdL\n   * AST and ALT ≤ 2.5 times upper limit of normal\n   * Creatinine ≤ 1.5 mg\u002FdL 10. Left ventricular ejection fraction ≥ 50% by echocardiogram or MUGA scan.\n\n11\\. Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to enrollment and agree to use birth control measures during study treatment and for 3 months after its completion. Patients must not be pregnant or nursing at study entry. Women\u002Fmen of reproductive potential must have agreed to use an effective contraceptive method.\n\nExclusion Criteria:\n\n1. Three or more systemic treatment lines (including both chemotherapy and targeted therapy) for advanced disease (localized unresectable or metastatic).\n2. Patients who have received any other anti-cancer therapy or investigational product in the last 21 days prior to enrollment.\n3. Prior malignancy that required treatment or has shown evidence of recurrence (except for non-melanoma skin cancer, adequately treated cervical carcinoma in situ, superficial bladder carcinoma) during the 5 years prior to randomization. Cancer treated with curative intent for \\>5 years previously and without evidence of recurrence will be allowed.\n4. Prior selinexor or another XPO1 inhibitor treatment.\n5. Administration of a previous gemcitabine-containing treatment.\n6. Any concurrent medical condition or disease (e.g. uncontrolled active hypertension, uncontrolled active diabetes, active systemic infection, etc.) that is likely to interfere with study procedures.\n7. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to Cycle 1 Day 1 (C1D1). Patients on prophylactic antibiotics or with a controlled infection within 1 week prior to C1D1 are acceptable.\n8. Pregnant or breastfeeding females.\n9. Body surface area (BSA) \\\u003C1.4 m2 at baseline, calculated by the Du Bois(25) or Mosteller(26) method.\n10. Life expectancy of less than 3 months.\n11. Major surgery within 4 weeks prior to C1D1.\n12. Any active gastrointestinal dysfunction interfering with the patient's ability to swallow tablets, or dysfunction that could interfere with absorption of study treatment.\n13. Inability or unwillingness to take supportive medications such as anti-nausea and anti-anorexia agents as recommended by the NCCN CPGO for antiemesis and anorexia\u002Fcachexia (palliative care).\n14. Any active, serious psychiatric, medical, or other conditions\u002Fsituations that, in the opinion of the Investigator, could interfere with treatment, compliance, or the ability to give informed consent. 15. Presence of brain or central nervous system metastases, unless they are controlled (patients with treated and stable metastasis are eligible)\n15. Presence of brain or central nervous system metastases, unless they are controlled (patients with treated and stable metastasis are eligible)","ALL","18 Years","80 Years",{"count":195,"type":196},88,"ESTIMATED","INTERVENTIONAL",[199],"PHASE2","Phase I-II, non-randomized, single-arm, open-label, multicenter, international clinical trial.\n\nPatients with advanced soft-tissue sarcoma (leiomyosarcoma or malignant peripheral nerve sheath tumor) will receive selinexor in combination with gemcitabine.",[202],"Sarcoma,Soft Tissue","2025-06-24",{"date":205,"type":206},"2025-06-25","ACTUAL",{"date":208,"type":206},"2023-09-28",{"date":210,"type":196},"2026-05-31",{"name":5,"class":6},11]