Detail of the clinical trial
| Title of the trial | A Randomized, Double-Blind, Placebo-Controlled, Phase IIIb Study of the Efficacy and Safety of Continuing Enzalutamide inChemotherapy Na?ve Metastatic Castration Resistant Prostate Cancer Patients Treated with Docetaxel plus Prednisolone Who Have Progressed on Enzalutamide Alone |
|---|---|
| EudraCT number | 2013-004711-50 |
| Protocol number | 9785-MA-1001 |
| Sponsor | Astellas Pharma Europe Limited, 300 Dashwood Lang Road, Bourne Business Park, Addlestone KT15 2NX, United Kingdom |
| Indications | Oncology |
| Diagnosis | prostate cancer |
| Population in clinical trial |
Adults (18-65 years) Elderly ( > 65 years) Male Patients |
| Year of receiving the request to Institute (SÚKL) | 2014 |
| Date of approval by Institute (SÚKL) | 24.11.2014 |
| Date of approval by EC | 13.11.2014 |
| Date of initiation CT in ČR | 12.2.2015 |
| Date of ending CT in ČR | |
| Notice | |
| Sites |
Fakultní nemocnice u Sv. Anny,Onkologická klinika,Pekařská 53,Brno,656 91 Fakultní nemocnice Olomouc,Onkologická klinika,I. P. Pavlova 6,Olomouc,77900 Fakultní nemocnice Plzeň,Onkologická klinika,Alej Svobody 80,Plzeň -Lochotín,30460 Všeobecná fakultní nemocnice V Praze,Onkologická klinika,U nemocnice 2,Praha 2,12808 |
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