Calendario›SNY›ZD6474
ZD6474
Efficacy and Safety of Zactima™ in Patients With Castration-refractory Metastatic Prostate Cancer
Ensayo de Sanofi en Cancer de prostata.
Más ensayos de: Cáncer de próstata.
- Fase
- Fase 2
- Estado
- Completado
- Participantes
- 95
- Centros
- 5
- Fin del objetivo primario
- nov 2010
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en feb 2008.
Qué mide
Prostate Specific Antigen (PSA) Progression Free Rate at 4 Months (del registro, en inglés) (4 meses)
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis randomized, double-blind phase II trial is to assess the efficacy and safety of bicalutamide (Casodex® ) associated to ZD6474 (Zactima™ ) or to placebo in patients with castration-refractory metastatic prostate cancer without any clinical symptom related to disease progression. The study is blinded, and subjects will be randomised (1:1 ratio) to either ZD6474 300 mg or placebo. The blinded design ensures robust, unbiased data collection and assessment. Placebo control is necessary to ensure a robust assessment of PSA PFS, and is acceptable in this subject population where all subjects will also received bicalutamide 150 mg o.d. Subjects will continue study treatment until they reach objective biological disease progression or unacceptable toxicity or withdrawal of consent or until end of trial (which event occurs first). The end of study is fixed 12 months after the last randomised patient's first dose of study treatment.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00659438), actualizada en oct 2016.