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

50 Participants
are divided into 1 treatment group

Locations

1
Department of Urology, Medical University of Vienna1090, Vienna Austria

Sponsors and collaborators

Ekaterina Laukhtina

Lead sponsor

Medical University of Vienna

Sponsor institution