drugset / Trial / NCT01437488

Cabazitaxel in Patients With Urothelial Carcinoma Who Have Disease Progression Following Platinum-Based Chemotherapy

NCT01437488

NaSingle-groupOpen-labelTreatment

Summary

There is no accepted standard chemotherapy approved for use in the second line for patients with advanced urothelial carcinoma whose cancer has progressed on combination chemotherapy including either cisplatin or carboplatin. The chemotherapy class called taxanes, either as single agents or in combination, have demonstrated modest efficacy in small studies. Cabazitaxel is an agent in the taxane family designed to be active in the setting of acquired multi-drug resistance that arises in some tumors. The objective of this study is to evaluate the safety and efficacy of this agent in patients with urothelial carcinoma refractory compared to combination platinum based chemotherapy.

Timeline

Start
2012-02-16
Primary completion
2014-08-04
Completion
2017-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Cabazitaxel Other / unclassified 20 mg/m2 Intravenous
Subject Cabazitaxel Other / unclassified 25 mg/m2 Intravenous
Background Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous

Indications