drugset / Trial / NCT01324583

Dose Escalation Study With Cabazitaxel in Combination With Daily Prednisolone in Patients With Hormone Refractory Prostate Cancer

NCT01324583

Phase 1 Completed 48 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

Summary

Primary Objective: * To assess the tolerability at global doses Secondary Objectives: * Safety * Pharmacokinetics * Efficacy

Timeline

Start
2011-01
Primary completion
2014-11
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Cabazitaxel Other / unclassified 15 mg/m2 Intravenous
Subject Cabazitaxel Other / unclassified 20 mg/m2 Intravenous
Subject Cabazitaxel Other / unclassified 25 mg/m2 Intravenous
Background Prednisolone Other / unclassified 10 mg Oral

Indications