Trials / Completed
CompletedNCT02074137
Evaluation of Safety of Cabazitaxel (Jevtana) in Patients With Metastatic Hormone Refractory Prostate Cancer
Multicentre, Single Arm, Open Label, Non Controlled Phase IV Clinical Trial to Evaluate Safety of Cabazitaxel (Jevtana) in Combination With Oral Prednisone (or Prednisolone) for the Treatment of Patients With Metastatic Hormone Refractory Prostate Cancer Previously Treated With a Docetaxel-containing Regimen
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed description
The study consists of: * a screening phase (maximum length of 7-day). * a treatment phase with 21-day study treatment cycles. Patients continue to receive treatment until disease progression , death, unacceptable toxicity, investigator's decision or withdrawal of consent. * a 30-day follow-up visit after the last dose of study medication.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CABAZITAXEL XRP6258 | Pharmaceutical form:Solution Route of administration: Intravenous |
| DRUG | Prednisone | Pharmaceutical form:Tablet Route of administration: Oral |
| DRUG | Prednisolone | Pharmaceutical form:Tablet Route of administration: Oral |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2016-03-01
- Completion
- 2016-03-01
- First posted
- 2014-02-28
- Last updated
- 2016-06-02
Locations
3 sites across 1 country: India
Source: ClinicalTrials.gov record NCT02074137. Inclusion in this directory is not an endorsement.