Combination of Cabazitaxel With Prednisolone With Primary Prophylaxis With PEG-G-CSF in Treatment of Patients With Prostate Cancer

PHASE4CompletedINTERVENTIONAL
Enrollment

21

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

February 29, 2016

Study Completion Date

November 30, 2016

Conditions
Prostate Cancer
Interventions
DRUG

CABAZITAXEL XRP6258

Pharmaceutical form:solution Route of administration: intravenous

DRUG

PEG-G-CSF

Pharmaceutical form:solution Route of administration: subcutaneous

DRUG

Prednisolone

Pharmaceutical form:tablet Route of administration: oral

DRUG

Dexchlorpheniramine or Diphenhydramine

Pharmaceutical form:tablet, powder, or solution Route of administration: oral, intravenous or intramuscular

DRUG

Ranitidine

Pharmaceutical form:tablet or solution Route of administration: oral, intravenous or intramuscular

DRUG

Metoclopramide, Granisetron, or Ondansetron

Pharmaceutical form:tablet, powder, jelly, or solution Route of administration: oral, intravenous or intramuscular

DRUG

Dexamethasone

Pharmaceutical form:tablet, capsule, or solution Route of administration: oral or intravenous

Trial Locations (8)

Unknown

Investigational Site Number 392004, Chuo-ku, Chiba

Investigational Site Number 392008, Kita-gun

Investigational Site Number 392007, Kobe-shi, Hyogo

Investigational Site Number 392005, Nagakute-shi, Aichi

Investigational Site Number 392006, Osaka Sayama-shi, Osaka

Investigational Site Number 392001, Shinjuku-ku, Tokyo

Investigational Site Number 392009, Yokohama

Investigational Site Number 392002, Yokohama-shi, Kanagawa

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Sanofi

INDUSTRY