NCT07034053

Clofarabine Therapy in Locally Advanced or Metastatic Urothelial Carcinoma

Clofarabine Therapy in Patients With Locally Advanced or Metastatic Urothelial Carcinoma: a Phase 1/2 Dose-Escalation Study

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Ekaterina Laukhtina · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 1/2 study will evaluate the maximum tolerated dose, efficacy, and safety of clofarabine in patients with advanced or metastatic urothelial cancer.

Detailed description

Clofarabine is an antimetabolite chemotherapeutic agent used as a subsequent line of treatment in pediatric patients with leukemia. In preclinical studies, it showed promising results, surpassing the effectiveness of the current standard of care. The study aims to define the maximum tolerated dose of clofarabine in patients with metastatic or locally advanced urothelial carcinoma. It also seeks to characterize the pharmacokinetics of clofarabine and assess the efficacy, safety, and tolerability of the treatment. The study population consists of patients with histologically confirmed urothelial carcinoma and radiologically documented metastatic or unresectable locally advanced disease, who have already received standard-of-care treatment. The study will be performed using a dose-escalation regimen.

Conditions

• Advanced Urothelial Carcinoma
• Metastatic Urothelial Cancer

Interventions

Type	Name	Description
DRUG	Clofarabine	Patients receive i.v. clofarabine in a dose-escalation regimen

Timeline

• Start date: 2023-10-24
• Primary completion: 2028-11-01
• Completion: 2028-11-01
• First posted: 2025-06-24
• Last updated: 2025-06-26

Locations

1 site across 1 country: Austria