drugset / Trial / NCT02961257

Trial Evaluating the Safety of 2 Schedules of Cabazitaxel in Elderly Men With mCRPC Previously Treated With a Docetaxel

NCT02961257

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the incidence of grade ≥ 3 neutropenia and/or neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in elderly men (≥ 65 years) with mCRPC previously treated with a docetaxel-containing regimen.

Timeline

Start
2017-05-05
Primary completion
2021-12-02
Completion
2021-12-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Cabazitaxel Other / unclassified 16 mg/m2 Intravenous
Subject Cabazitaxel Other / unclassified 25 mg/m2 Intravenous
Background Lenograstim Protein / enzyme biologic Other
Background Prednisone Other / unclassified 10 mg Oral