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Genital Diseases, Male

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25 mg/m\^2 of cabazitaxel is given intravenously in combination with prednisolone 10 mg orally per day. PEG-G-CSF is administered subcutaneously 24 hours after the completion of cabazitaxel infusion once every 3 weeks.

Antihistamine (dexchlorpheniramine or diphenhydramine), corticosteroids (dexamethasone), and H2 antagonist (ranitidine) premedications will be administered by IV infusion at least 30 minutes prior to each dose of cabazitaxel. A prophylactic antiemetic treatment (metoclopramide, granisetron, or ondansetron) should be given to the patients in all cycles.

Pharmaceutical form:solution Route of administration: intravenous

CABAZITAXEL XRP6258

Pharmaceutical form:solution Route of administration: subcutaneous

PEG-G-CSF

Pharmaceutical form:tablet Route of administration: oral

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

Dexchlorpheniramine or Diphenhydramine

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

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

Metoclopramide, Granisetron, or Ondansetron

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

Clinical Sciences & Operations

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.

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.

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

Sanofi

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Combination of Cabazitaxel With Prednisolone With Primary Prophylaxis With PEG-G-CSF in Treatment of Patients With Prostate Cancer	NCT02441894	Prostate Cancer	CABAZITAXEL XRP... PEG-G-CSF Prednisolone Dexchlorphenira... Ranitidine Metoclopramide,... Dexamethasone	20 Years -	Sanofi
Combination of Cabazitaxel With Prednisolone With Primary Prophylaxis With PEG-G-CSF in Treatment of Patients With Prostate Cancer	NCT02441894	Prostate Cancer	CABAZITAXEL XRP... PEG-G-CSF Prednisolone Dexchlorphenira... Ranitidine Metoclopramide,... Dexamethasone	20 Years -	Sanofi

Spots Global Cancer Trial Database for metoclopramide, granisetron, or ondansetron