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Trials / Completed

CompletedNCT01810770

Radium-223 Dichloride Asian Population Study in the Treatment of CRPC Patients With Bone Metastasis

A Single-arm, International, Prospective, Interventional, Open-label, Multicenter Study of Radium-223 Dichloride in the Treatment of Patients With Castration-Resistant Prostate Cancer (CRPC) With Bone Metastasis.

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
243 (actual)
Sponsor
Bayer · Industry
Sex
Male
Age
18 Years
Healthy volunteers
Not accepted

Summary

To evaluate the safety and efficacy (Overall survival \[OS\]) of multiple doses of Ra-223 dichloride in an Asian population of subjects with CRPC metastatic to the bone.

Conditions

Interventions

TypeNameDescription
DRUGRadium-223 dichloride (Xofigo, BAY88-8223)Radium-223 dichloride, 55 kBq/kg body weight, will be administered as a slow bolus IV injection at 4 week intervals for up to 6 doses.

Timeline

Start date
2013-03-26
Primary completion
2017-09-25
Completion
2017-09-25
First posted
2013-03-14
Last updated
2018-09-19

Locations

27 sites across 4 countries: China, Singapore, South Korea, Taiwan

Source: ClinicalTrials.gov record NCT01810770. Inclusion in this directory is not an endorsement.

Radium-223 Dichloride Asian Population Study in the Treatment of CRPC Patients With Bone Metastasis (NCT01810770) · Clinical Trials Directory