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

• Status: Completed
• Trial end date: 2016-06-01

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.

• Phase: Phase 4

Details

• Lead Sponsor: Sanofi
• Treatments: Ciprofloxacin; Lenograstim; Prednisone; Sargramostim