MedTrace Logo

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

NCT01649635 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2016-07-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

CABAZITAXEL (XRP6258)

Pharmaceutical form: solution Route of administration: intravenous

DRUG

Prednisone

Pharmaceutical form: tablet Route of administration: oral

DRUG

Ciprofloxacin

Pharmaceutical form: tablet Route of administration: oral

DRUG

G-CSF (Granulocyte colony-stimulating factor)

Pharmaceutical form: solution Route of administration: subcutaneous

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
2012-07-31
Primary Completion
2014-01-31
Completion
2016-06-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT01649635 on ClinicalTrials.gov