Prostate Cancer Clinical Trial
Official title:
Cabazitaxel in Combination With Prednisolone With Primary Prophylaxis With PEG-G-CSF for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer
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. ;
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