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Clofarabine Therapy in Patients with Locally Advanced or Metastatic Urothelial Carcinoma: a Phase 1/2 Dose-Escalation Study
EU CTIS ID: 2024-516586-37-00
What this study is testing
To define maximum tolerated dose of Clofarabine in patients with metastatic or locally advanced urothelial carcinoma
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with histologically or cytologically confirmed urothelial carcinoma, radiologically documented metastatic or unresectable locally advanced disease
- 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
- Adequate cardiac function (NYHA cardiac III-IV excluded)
- Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment
- Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
- Willing and able to provide informed consent
You likely can't join if
- Received previous treatment with clofarabine
- 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
- Positive human immunodeficiency virus (HIV) test
- Female patients who are pregnant/breastfeeding
- Current concomitant chemotherapy, radiation therapy, or immunotherapy
- Currently participation in other investigational drug studies or having received other investigational drugs within the previous 30 days
See the full eligibility criteria
Who can join
- Patients with histologically or cytologically confirmed urothelial carcinoma, radiologically documented metastatic or unresectable locally advanced disease
- 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
- Adequate cardiac function (NYHA cardiac III-IV excluded)
- Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment
- Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
- Willing and able to provide informed consent
- Patients who have already received standard treatment and did not benefit from it, or patients who have refused standard therapy
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) greater than or equal to 1500
- White blood cell (WBC) count greater than 3.0
- Platelets greater than or equal to 100
- Hemoglobin greater than 9.0 g/dL
- 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
What rules you out
- Received previous treatment with clofarabine
- 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
- Positive human immunodeficiency virus (HIV) test
- Female patients who are pregnant/breastfeeding
- Current concomitant chemotherapy, radiation therapy, or immunotherapy
- Currently participation in other investigational drug studies or having received other investigational drugs within the previous 30 days
- 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
- 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)
- 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)
- 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
- 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
- Had currently active gastrointestinal disease, or prior surgery that might affect the ability of the participants to absorb oral Clofarabine
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.