283
Participants
Start Date
June 4, 2015
Primary Completion Date
January 22, 2020
Study Completion Date
October 28, 2022
Radium-223 dichloride (Xofigo, BAY88-8223)
Up to 6 cycles of radium-223 dichloride 50kBq/kg body (55 kBq/kg after implementation of NIST update)
Placebo (saline)
Up to 6 cycles of saline injection
Exemestane
One 25 mg tablet once daily after a meal.
Everolimus
"The recommended dose of everolimus administered in the study is 10 mg once daily with or without food.~Starting dose, dose modifications, and administration of exemestane and everolimus must be in compliance with the local labels in each of the participating countries and/or in line with local standard of practice."
Taipei
Brussels
Edegem
Leuven
Aarau
Innsbruck
New Haven
Barcelona
Kortrijk
Jamaica
Genoa
Milan
Rockville
Cremona
Madrid
Madrid
Madrid
Madrid
Nîmes
Pamplona
Hollywood
Tours
Bologna
Taichung
Seville
Seville
Ashland
Modena
Daegu
Herne
Nantes
Forlì Cesena
Ann Arbor
Detroit
Pontiac
Angers
Busan
Rochester
Pisa
Watertown
St Louis
Tel Aviv
Bari
Los Angeles
La Jolla
Saint-Cloud
Singapore
Singapore
Singapore
Kaohsiung City
Afula
Haifa
Ramat Gan
Holon
Zrifin
Beersheba
Jerusalem
Jerusalem
Newark
Spokane
Chai Wan
Hong Kong
Kowloon
Incheon
Taipei
Rome
Rome
Nagoya
Sapporo
Sayama
Hidaka
Kita-Adachigun
Koto-ku
Kagoshima
Osaka
Oslo
Bialystok
Gdansk
Gdynia
Poznan
Warsaw
Suwon
Seoul
Seoul
Palma de Mallorca
Barcelona
Barcelona
Truro
Plymouth
Nottingham
Taunton
Bristol
Lead Sponsor
Bayer
INDUSTRY