Phase 12 Study of Clofarabine Treatment for Advanced or Metastatic Urothelial Carcinoma

What this Trial Is About

Researchers are evaluating clofarabine, a chemotherapy drug, in patients with advanced or metastatic urothelial carcinoma who have already received standard treatments. This phase 12 study aims to find the highest dose that patients can tolerate, understand how the drug moves through the body, and assess its safety and effectiveness. The study focuses on patients with confirmed urothelial cancer that is metastatic or locally advanced and not surgically removable. Participants receive intravenous clofarabine following a dose-escalation plan to determine the maximum tolerated dose. The study includes patients who have previously undergone standard care or refused it. The treatment period includes dosing cycles, with evaluations based on side effects and responses. The study monitors patients through dosing and for up to 90 days after the last dose for safety and tolerability. During the study, participants undergo various assessments including blood tests to check blood counts, liver and kidney function, and cardiac status. Researchers measure outcomes such as dose-limiting toxicities within the first 28 days, objective tumor responses, duration of response, progression-free survival, and overall survival over up to 36 months. Pharmacokinetic measures like drug concentration in the blood are also tracked. The study is expected to continue until November 2028, with participants closely monitored throughout.

Clofarabine Therapy in Locally Advanced or Metastatic Urothelial Carcinoma