前立腺癌患者の治療におけるカバジタキセルとプレドニゾロンの併用療法とPEG-G-CSFによる一次予防
基本情報
- NCT ID
- NCT02441894
- ステータス
- 完了
- 試験のフェーズ
- 第4相
- 試験タイプ
- 介入
- 目標被験者数
- 21
- 治験依頼者名
- Sanofi
概要
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.