Calendario›SNY›CABAZITAXEL XRP6258 · PEGAZUS

CABAZITAXEL XRP6258 · PEGAZUS

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

Ensayo de Sanofi en Cancer de prostata.

Más ensayos de: Cáncer de próstata.

Fase

Fase 4

Estado

Completado

Participantes

21

previstos

Centros

8

Fin del objetivo primario

feb 2016

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, de un solo grupo, abierto. Comenzó en abr 2015.

Qué mide

Number of patients with FN (all grades) during study Cycle 1 (3 weeks (during study Cycle 1)) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroPrimary 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.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT02441894), actualizada en ene 2017.