drugset / Trial / NCT02074137
Evaluation of Safety of Cabazitaxel (Jevtana) in Patients With Metastatic Hormone Refractory Prostate Cancer
NaSingle-groupOpen-labelTreatment
Summary
Primary Objective: To evaluate the safety of cabazitaxel (Jevtana) in patients with metastatic hormone refractory prostate cancer Secondary Objectives: 1. To describe the use of cabazitaxel (Jevtana) in combination with oral prednisolone for the treatment of patients with metastatic Hormone Refractory Prostate Cancer 2. To describe patient profile in terms of demography, disease characteristics and prior treatment history 3. To describe efficacy outcomes: radiological response (if available) using Recist criteria V 1.1 and Prostate Specific Antigen (PSA) response
Timeline
- Start
- 2014-07
- Primary completion
- 2016-03
- Completion
- 2016-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cabazitaxel | Other / unclassified | 25 mg/m2 | Intravenous |
| Background | Prednisolone | Other / unclassified | 10 mg | Oral |
| Background | Prednisone | Other / unclassified | 10 mg | Oral |