BAY88-8223, Dose Finding Study in Patients With HRPC
Completed
Bayer
Phase 2
The purpose of this study is to evaluate the effectiveness of the investigational
radioisotope Radium-223, Alpharadin, in treatment of men with prostate cancer and bone
metastases that no longer respond to hormonal treatment.
A Placebo-controlled Phase II Study of Bone-targeted Radium-223 in Symptomatic Hormone-refractory Prostate Cancer
Completed
Bayer
Phase 2
The purpose of this study is to evaluate the effectiveness of the investigational
radioisotope Radium-223 in treatment of men with prostate cancer and bone metastases that no
longer respond to hormonal treatment.
The purpose of this study is to evaluate the efficacy and safety of the investigational
radioisotope Radium-223, Xofigo (Alpharadin), in treatment of men with prostate cancer and
bone metastases that no longer respond to hormonal treatment.
Primary objective: To investigate the biodistribution, radiation dosimetry, and
pharmacokinetics of two separate intravenous (IV) injections of Xofigo (100 kBq/kg body
weight [b.w.] [=110 kBq/kg based on the 2015 National Institute of Standards and Technology
standardization], 6 weeks apart).
Secondary objectives: To determine the safety of IV injections of Xofigo after two separate
injections (6 weeks apart), to evaluate treatment response (antitumour effect in osteoblastic
bone metastases) of Xofigo treatment consisting of two injections of activity 100 kBq/kg b.w.
(=110 kBq/kg based on the 2015 National Institute of Standards and Technology
standardization), 6 weeks apart and to evaluate long term radiation toxicity and to collect
survival data at 6 and 12 months after the first injection
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models.
By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.
