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

• Status: Completed
• Trial end date: 2016-11-01

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.

• Phase: Phase 4

Details

• Lead Sponsor: Sanofi
• Treatments: BB 1101; Chlorpheniramine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Dexchlorpheniramine; Diphenhydramine; Granisetron; Lenograstim; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Metoclopramide; Ondansetron; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Promethazine; Ranitidine; Ranitidine bismuth citrate