CLOFARABINE for Urothelial carcinoma

Inclusion criteria

• {"criterion_text":"- Patients with histologically or cytologically confirmed urothelial carcinoma, radiologically documented metastatic or unresectable locally advanced disease"}
• {"criterion_text":"- Adequate renal function as indicated by the following laboratory values: Serum creatinine ≤ 1.0 mg/dL; if serum creatinine > 1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 60 mL/min/1.73 m^2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation"}
• {"criterion_text":"- Adequate cardiac function (NYHA cardiac III-IV excluded)"}
• {"criterion_text":"- Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment"}
• {"criterion_text":"- Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment"}
• {"criterion_text":"- Willing and able to provide informed consent"}
• {"criterion_text":"- Patients who have already received standard treatment and did not benefit from it, or patients who have refused standard therapy"}
• {"criterion_text":"- Age ≥ 18 years"}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status 0-2"}
• {"criterion_text":"- Absolute neutrophil count (ANC) greater than or equal to 1500"}
• {"criterion_text":"- White blood cell (WBC) count greater than 3.0"}
• {"criterion_text":"- Platelets greater than or equal to 100"}
• {"criterion_text":"- Hemoglobin greater than 9.0 g/dL"}
• {"criterion_text":"- 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"}

Exclusion criteria

• {"criterion_text":"- Received previous treatment with clofarabine"}
• {"criterion_text":"- 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 <7 days apart during the 2- week period prior to the first dose of study drug"}
• {"criterion_text":"- Positive human immunodeficiency virus (HIV) test"}
• {"criterion_text":"- Female patients who are pregnant/breastfeeding"}
• {"criterion_text":"- Current concomitant chemotherapy, radiation therapy, or immunotherapy"}
• {"criterion_text":"- Currently participation in other investigational drug studies or having received other investigational drugs within the previous 30 days"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Patients with a systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment)"}
• {"criterion_text":"- Any medical condition that requires chronic use of oral high-dose corticosteroids (in excess of 1 mg/kg/day) (low-dose corticosteroid for pre-medication purposes are allowed)"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Had currently active gastrointestinal disease, or prior surgery that might affect the ability of the participants to absorb oral Clofarabine"}

Primary endpoints

• {"endpoint_text":"- Maximum tolerated dose (MTD)","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Objective response (OR) determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1","definition_or_measurement_approach":"Determined by RECIST 1.1"}
• {"endpoint_text":"- Duration of response (DOR) (radiographic)","definition_or_measurement_approach":"Radiographic assessment"}
• {"endpoint_text":"- Time to progression (radiographic)","definition_or_measurement_approach":"Radiographic assessment"}
• {"endpoint_text":"- Progression-free survival (PFS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Treatment-related adverse events evaluated using the National Cancer Institute’s Common Terminology Criteria for Adverse Events (version 5.0)","definition_or_measurement_approach":"Adverse events graded using NCI CTCAE v5.0"}
• {"endpoint_text":"- Pharmacokinetics parameters of Clofarabine including maximum serum concentration (Cmax) and area under the concentration-time curve (AUC)","definition_or_measurement_approach":"PK parameters including Cmax and AUC"}

Austria

Earliest CTIS Part Ii Submission Date

20-09-2024

Latest Decision Or Authorization Date

14-10-2024

Processing Time Days

24

Number Of Sites

1

Number Of Participants

50

Primary sponsor

Full Name

Medical University Of Vienna

Organisation Type

Educational Institution

Country Of Registered Address

Austria