[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ekaterina Laukhtina\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"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":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23,24],"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.",[27,28],"Advanced Urothelial Carcinoma","Metastatic Urothelial Cancer","RECRUITING","2025-06-23",{"date":32,"type":33},"2025-06-26","ACTUAL",{"date":35,"type":33},"2023-10-24",{"date":37,"type":20},"2028-11",{"name":39,"class":40},"Ekaterina Laukhtina","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":41},"100594421","phase-2-chemoablation-for-low-grade-bladder-cancer-100594421","NCT07019220","Chemoablation for Low-Grade Bladder Cancer","COBRA - Chemoablation for Low Grade Bladder Cancer: A Single Arm, Prospective, Open-label, Investigator-initiated Phase 2 Study","COBRA","Inclusion Criteria:\n\n* Male\u002Ffemale participants who are at least 18 years of age on the day of providing documented informed consent will be enrolled in this study\n* Diagnosis of a recurrent tumor and a history of TaLG BCa or diagnosis of primary TaLG BCa histologically confirmed by cold cup biopsy at screening or within 8 weeks before screening\n* On screening cystoscopy: Diameter of the largest lesion ≤15mm\n* Number of lesions ≤5\n* Cystoscopy with bladder diagram including number, site, size and appearance of the tumors with photo documentation\n* Patient who has recurrence of and not other than TaLG NMIBC (low or intermediate EAU risk)\n* NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT)\n* Negative voiding cytology for high grade (HG) disease within 8 weeks before Screening\n* No lymph node metastasis or distant metastasis\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. Female patients of childbearing potential must use adequate contraception during study period\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Tumors that clinicians suspect to be HG\n* Positive HG cytology according to Paris criteria\n* Diameter of tumor \\>15 mm\n* Number of lesions \\>5\n* Any previous intravesical therapy within 1 year\n* Previous HG NMIBC (within the last 3 years). It is allowed to include patients who had history of HG disease longer than 3 years ago.\n* Past or current muscle invasive bladder cancer (i.e., T2, T3, T4) or metastatic UC\n* History of upper tract urothelial carcinoma (UTUC)\n* Clinically significant urethral stricture that would preclude passage of a urethral catheter\n* History of neurogenic bladder; active urinary retention; any other condition that would prohibit normal voiding\n* Evidence of active urinary tract infection (UTI) that in the Investigator's opinion cannot be treated and resolved prior to biopsy and\u002For administration of study treatment\n* Patient refused to participate\n* Known positive human immunodeficiency virus (HIV) test.\n* Female patients who are pregnant\u002Fbreastfeeding.\n* Female patients of childbearing potential not using adequate contraception.",{"count":51,"type":20},47,[24],"The goal of this single arm, prospective, open-label, investigator-initiated Phase 2 clinical trial is to evaluate the efficacy of intravesical chemoablation in patients with low grade bladder cancer.",[55],"Bladder (Urothelial, Transitional Cell) Cancer",[57,58,59],"Non-Muscle Invasive Bladder Cancer","Intravesical Therapy","Non-Surgical Treatment","2025-06-12",{"date":62,"type":33},"2025-06-13",{"date":64,"type":33},"2023-12-27",{"date":66,"type":20},"2027-11",{"name":39,"class":40},""]