drugset / Trial / NCT01649635

Study of Cabazitaxel Combined With Prednisone and Prophylaxis of Neutropenia Complications in the Treatment of Patients With Metastatic Castration-resistant Prostate Cancer

NCT01649635

Phase 4 Completed 45 enrolled Sanofi
NaSingle-groupOpen-labelTreatment

Summary

Primary Objective: \- To assess effectiveness of prophylactic treatment of hematological complications (grade ≥ 3 neutropenia) resulting from cabazitaxel treatment for 21 days after treatment initiation. Secondary Objectives: * PSA response rate; * Descriptive assessment of CTC (circulating Tumor Cells); * Rates of grade ≥ 3 neutropenia and febrile neutropenia and grade ≥3 diarrhea over the treatment period; * Description of the Health Quality of Life of the patients; * Incidence of adverse events.

Timeline

Start
2012-07
Primary completion
2014-01
Completion
2016-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Cabazitaxel Other / unclassified 25 mg/m2 Intravenous
Background Ciprofloxacin Small molecule 500 mg Oral
Background Prednisone Other / unclassified 10 mg Oral

Indications