NCT02441894

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

Cabazitaxel in Combination With Prednisolone With Primary Prophylaxis With PEG-G-CSF for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Sanofi · Industry
• Sex: Male
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The total duration of study is 254 days as maximum with 14 days for screening, maximum of 21 days times 10 cycles for treatment, and 30 days for follow up.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-02-01
• Completion: 2016-11-01
• First posted: 2015-05-12
• Last updated: 2017-01-24

Locations

8 sites across 1 country: Japan