[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628133":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":47,"collaborators":19,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":19,"enrollmentInfo":59,"targetDuration":19,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":70,"whyStopped":19,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Tarian Pharma","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TAR-0520 gel","EXPERIMENTAL","Treatment of the hands",[13],"Drug: TAR-0520 gel",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","hands treatment",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Janusz M Czernielewski, MD","CONTACT","+33680338274","janusz.czernielewski@tarianpharma.com",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"Alexandra Lamquin, PhD","+33623363962","alexandra.lamquin@tarianpharma.com",[31],{"facility":32,"status":19,"city":33,"state":19,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Instiut Paoli-Calmettes","Marseille","13009","France","FR",{"type":38,"coordinates":39},"Point",[40,41],5.38107,43.29695,{"lat":41,"lon":40},[44],{"name":45,"role":23,"phone":46,"phoneExt":19,"email":19},"Emmanuel Mitry, MD","+33491223333",{"type":48,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100628133","phase-2-tar-0520-gel-in-hand-and-foot-syndrome-100628133",false,"NCT07457671","TAR-0520 Gel in Hand and Foot Syndrome","A Phase 2a Exploratory Study of TAR-0520 Gel in Prevention of Hand and Foot Syndrome","TARIAN008","Inclusion Criteria:\n\n* Medical diagnosis of breast or colorectal cancer planned to be treated with capecitabine\n* at a dose \\> 1000mg\u002Fm² twice daily every 2 out of 3 weeks as single agent chemotherapy\n* Patients with life expectancy graeter than 12 weeks\n\nExclusion Criteria:\n\n* Patient with medical history of capecitabine treatment\n* patient with pre-existing neuropathy confounding assessement of HFS\n* Patient with Raynaud's syndrome or other vascular peripheral disorders\n* Patient with dermatological lesions on hands or foot","ALL","18 Years",{"count":60,"type":61},25,"ESTIMATED","INTERVENTIONAL",[64],"PHASE2","Hand and Foot Syndrome (HFS) is a weii-established and frequent cutaneous adverse event of capecitabine used in the treatment of different cancers.HFS is charectirized by a variety of symptoms ranging from mild discomfort to a painful sensation of palms and sols that could limit functionality and hamper patients on their daily activities.\n\nThe aim of this study is to explore the TAR-0520 gel safety and preventive efficacy of HFS in patients with colorectal and breast cancer patients treated with capecitabine.\n\nIs the product well tolerated locally and systemically ? Is the product reducing frequency and severity of HFS ? Is product improving Quality of Life (QoL) of treated patients ? Each patient will receive the active TAR-0520 gel and they will apply it to both hands,twice daily. Applications will be done 1 hour before each morning and evening capecitabine oral intake.\n\nFeet will be not treated and will serve as controls. In total , this study will follow patients during 4 capecitabine Cycles (each Cycle=21 days) for a total of 12 weeks.\n\nClinical evaluations will take place at Day1 of each Cycle and will be conducted separetaly on hands and feet.",[67],"Hand and Foot Syndrome",[67,69],"Prevention of Hand and Foot Syndrome","NOT_YET_RECRUITING","2026-03-03",{"date":73,"type":74},"2026-03-09","ACTUAL",{"date":76,"type":61},"2026-03",{"date":78,"type":61},"2027-06",{"name":5,"class":6},1]