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

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516586-37-00
Enrollment
50
Registered
2024-10-14
Start date
2023-10-24
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial carcinoma

Brief summary

Maximum tolerated dose (MTD)

Detailed description

Objective response (OR) determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, Duration of response (DOR) (radiographic), Time to progression (radiographic), Progression-free survival (PFS), Overall survival (OS), Treatment-related adverse events evaluated using the National Cancer Institute’s Common Terminology Criteria for Adverse Events (version 5.0), Pharmacokinetics parameters of Clofarabine including maximum serum concentration (Cmax) and area under the concentration-time curve (AUC)

Interventions

DRUGEvoltra 1 mg/ml concentrate for solution for infusion

Sponsors

Medical University Of Vienna
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Maximum tolerated dose (MTD)—

Secondary

MeasureTime frame
Objective response (OR) determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, Duration of response (DOR) (radiographic), Time to progression (radiographic), Progression-free survival (PFS), Overall survival (OS), Treatment-related adverse events evaluated using the National Cancer Institute’s Common Terminology Criteria for Adverse Events (version 5.0), Pharmacokinetics parameters of Clofarabine including maximum serum concentration (Cmax) and area under the concentration-time curve (AUC)—

Countries

Austria

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026