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

NCT02441894 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2017-01-24

No results posted yet for this study

Summary

Primary Objective:

To assess the tolerability of cabazitaxel 25 mg per body surface area (m\^2) with primary prophylactic polyethylene glycol-granulocyte-colony stimulating factor (PEG-G-CSF) in terms of the incidence rate of febrile neutropenia (FN) (defined: absolute neutrophil count \[ANC\] \<1000 per volume \[mm\^3\] and a single temperature of \>38.3 degree or a sustained temperature of ≥38 degree Celsius for more than one hour) during Cycle 1.

Secondary Objective:

To assess overall rate of FN and grade ≥3 neutropenia and diarrhea; frequencies of dose delay due to adverse events (AEs); dose reduction due to AEs; relative dose intensity; incidences of FN-related hospitalization and use of intravenous (IV) anti-infectives; tolerability according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0; prostate specific antigen (PSA) response (50% decrease); tumor response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 if available.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-02-29
Completion
2016-11-30

Countries

  • Japan

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 NCT02441894 on ClinicalTrials.gov