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Evaluation of Safety of Cabazitaxel (Jevtana) in Patients With Metastatic Hormone Refractory Prostate Cancer

NCT02074137 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-06-02

No results posted yet for this study

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

Conditions

  • Prostate Cancer Metastatic

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02074137 on ClinicalTrials.gov