Actively Recruiting
Clofarabine Therapy in Locally Advanced or Metastatic Urothelial Carcinoma
Led by Ekaterina Laukhtina · Updated on 2025-06-26
50
Participants Needed
1
Research Sites
262 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase 1/2 study will evaluate the maximum tolerated dose, efficacy, and safety of clofarabine in patients with advanced or metastatic urothelial cancer.
CONDITIONS
Official Title
Clofarabine Therapy in Locally Advanced or Metastatic Urothelial Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have histologically or cytologically confirmed urothelial carcinoma with metastatic or unresectable locally advanced disease documented by imaging
- Have already received standard treatment without benefit or refused standard therapy
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2
- Absolute neutrophil count (ANC) of at least 1500
- White blood cell count greater than 3.0
- Platelet count of at least 100
- Hemoglobin level greater than 9.0 g/dL
- Adequate liver function: total bilirubin no higher than 1.5 times the upper limit of normal; AST and ALT no higher than 2.5 times the upper limit of normal
- Adequate kidney function: serum creatinine at or below 1.0 mg/dL or estimated glomerular filtration rate over 60 mL/min/1.73 m² if creatinine is higher
- Adequate heart function (excluding New York Heart Association cardiac stage III-IV)
- Willingness to use effective contraception during the study and for at least six months afterward
- Female participants of childbearing potential must have a negative serum pregnancy test within 2 weeks before enrollment
- Willing and able to provide informed consent
You will not qualify if you...
- Previous treatment with clofarabine
- Receiving chemotherapy, radiation therapy, or immunotherapy currently
- Prior radiation therapy to the pelvis
- Participation in other investigational drug studies or recent investigational drug use within 30 days
- Severe concurrent diseases or serious organ dysfunction involving heart, kidney, liver, or other systems that increase treatment risk, including NYHA cardiac stage II-IV congestive heart failure, recent coronary artery disease or arteriosclerotic cardiovascular disease within 3 months, or other primary cardiac diseases increasing risk
- Uncontrolled systemic infections
- Chronic use of high-dose oral corticosteroids (above 1 mg/kg/day), except low-dose corticosteroids for pre-medication
- Significant concurrent illness or psychiatric disorder that may affect safety, consent, compliance, or study participation
- Diagnosis of another malignancy unless disease-free for at least 5 years after curative treatment, with specific exceptions for certain skin and prostate cancers
- Active gastrointestinal disease or prior surgery affecting oral clofarabine absorption
- Recent use of nephrotoxic drugs within 2 weeks before study drug unless stable kidney function confirmed
- Positive HIV test
- Pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Department of Urology, Medical University of Vienna
Vienna, Austria, 1090
Actively Recruiting
Research Team
E
Ekaterina Laukhtina Dr., Medical Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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