About this trial
This phase 1/2 study will evaluate the maximum tolerated dose, efficacy, and safety of clofarabine in patients with advanced or metastatic urothelial cancer.
Eligibility criteria
Qualifiers
Patients with histologically or cytologically confirmed urothelial carcinoma, radiologically documented metastatic or unresectable locally advanced disease
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
Disqualifiers
Received previous treatment with clofarabine
Current concomitant chemotherapy, radiation therapy, or immunotherapy
Prior radiation therapy to the pelvis
Currently participation in other investigational drug studies or having received other investigational drugs within the previous 30 days
Trial design
Treatments tested in this trial
- Clofarabine
Treatment groups
Sponsors and collaborators
Ekaterina Laukhtina
Lead sponsor
Medical University of Vienna
Sponsor institution