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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cabazitaxel | Other / unclassified | 25 mg/m2 | Intravenous |
| Background | Ciprofloxacin | Small molecule | 500 mg | Oral |
| Background | Prednisone | Other / unclassified | 10 mg | Oral |