[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595561":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":47,"collaborators":11,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":11,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":11,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":67,"conditions":68,"keywords":11,"overallStatus":34,"whyStopped":11,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with urothelial carcinoma treated with clofarabine","EXPERIMENTAL",null,[13],"Drug: Clofarabine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"DRUG","Clofarabine","Patients receive i.v. clofarabine in a dose-escalation regimen",[9],[21],{"name":22,"affiliation":23,"role":24},"Shahrokh F. Shariat Prof. Dr., Professor","Department of Urology, Medical University of Viernna","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},"Ekaterina Laukhtina Dr., Medical Doctor","CONTACT","+43 (0)1 40400-26315","ekaterina.laukhtina@meduniwien.ac.at",[32],{"facility":33,"status":34,"city":35,"state":11,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Department of Urology, Medical University of Vienna","RECRUITING","Vienna","1090","Austria","AT",{"type":40,"coordinates":41},"Point",[42,43],16.37208,48.20849,{"lat":43,"lon":42},[46],{"name":27,"role":28,"phone":29,"phoneExt":11,"email":30},{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Ekaterina Laukhtina","Dr. Sponsor-Investigator","100595561","phase-1-clofarabine-therapy-in-locally-advanced-or-metastatic-urothelial-carcinoma-100595561",false,"NCT07034053","Clofarabine Therapy in Locally Advanced or Metastatic Urothelial Carcinoma","Clofarabine Therapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma: a Phase 1\u002F2 Dose-Escalation Study","Inclusion Criteria:\n\n* Patients with histologically or cytologically confirmed urothelial carcinoma, radiologically documented metastatic or unresectable locally advanced disease\n* Patients who have already received standard treatment and did not benefit from it, or patients who have refused standard therapy\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n* Absolute neutrophil count (ANC) greater than or equal to 1500.\n* White blood cell (WBC) count greater than 3.0.\n* Platelets greater than or equal to 100.\n* Hemoglobin greater than 9.0 g\u002FdL.\n* Adequate hepatobiliary function as indicated by the following laboratory values: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN\n* Adequate renal function as indicated by the following laboratory values: Serum creatinine ≤ 1.0 mg\u002FdL; if serum creatinine \\> 1.0 mg\u002FdL, then the estimated glomerular filtration rate (GFR) must be \\> 60 mL\u002Fmin\u002F1.73 m\\^2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation\n* Adequate cardiac function (NYHA cardiac III-IV excluded)\n* Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment\n* Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Received previous treatment with clofarabine\n* Current concomitant chemotherapy, radiation therapy, or immunotherapy\n* Prior radiation therapy to the pelvis\n* Currently participation in other investigational drug studies or having received other investigational drugs within the previous 30 days\n* Have any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo treatment. In particular: a) New York Heart Association classification stage II, III, or IV congestive heart failure; b) Coronary artery disease or arteriosclerotic cardiovascular disease (angina, myocardial infraction) within 3 months of first dose of study drug; c) Any other primary cardiac disease that, in the opinion of the investigator, increases the risk of ventricular arrhythmia.\n* Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs\u002Fsymptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).\n* Any medical condition that requires chronic use of oral high-dose corticosteroids (in excess of 1 mg\u002Fkg\u002Fday) (low-dose corticosteroid for pre-medication purposes are allowed).\n* Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow up, or interpretation of study results\n* Diagnosis of another malignancy, unless the patient has been disease-free for at least 5 years following the completion of curative intent therapy with the following exceptions: Patients with treated non-melanoma skin cancer, in-situ carcinoma or cervical intraepithelial neoplasia regardless of disease-free duration are eligible for this study if definitive treatment for the condition has been completed; Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on PSA value are eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed\n* Had currently active gastrointestinal disease, or prior surgery that might affect the ability of the participants to absorb oral Clofarabine.\n* Had prior treatment with a known nephrotoxic drug within 2 weeks of the first dose of study drug, unless the participants had a calculated GFR \\>30 at 2 time points no \\\u003C7 days apart during the 2- week period prior to the first dose of study drug.\n* Positive human immunodeficiency virus (HIV) test.\n* Female patients who are pregnant\u002Fbreastfeeding.","ALL","18 Years",{"count":61,"type":62},50,"ESTIMATED","INTERVENTIONAL",[65,66],"PHASE1","PHASE2","This phase 1\u002F2 study will evaluate the maximum tolerated dose, efficacy, and safety of clofarabine in patients with advanced or metastatic urothelial cancer.",[69,70],"Advanced Urothelial Carcinoma","Metastatic Urothelial Cancer","2025-06-23",{"date":73,"type":74},"2025-06-26","ACTUAL",{"date":76,"type":74},"2023-10-24",{"date":78,"type":62},"2028-11",{"name":49,"class":6},1]