Clinical Trials Directory

Trials / Completed

CompletedNCT01929655

Japanese BAY88-8223 Monotherapy Phase II Study

A Single-arm, Open-label, Multicenter, Phase II Study of BAY88-8223 in the Treatment of Japanese Patients With Symptomatic Castration-resistant Prostate Cancer (CRPC) With Bone Metastases

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
49 (actual)
Sponsor
Bayer · Industry
Sex
Male
Age
20 Years
Healthy volunteers
Not accepted

Summary

To evaluate the efficacy and safety of the best standard of care plus BAY88-8223 in Japanese patients with CRPC and bone metastases after a multiple administration

Conditions

Interventions

TypeNameDescription
DRUGRadium-223 dichloride (Xofigo, BAY88-8223)BAY88-8223, 50 kBq/kg will be administered as slow bolus intravenous injection 6 times at intervals of 4 weeks between each administration

Timeline

Start date
2013-09-30
Primary completion
2017-05-16
Completion
2017-05-16
First posted
2013-08-28
Last updated
2018-04-24

Locations

16 sites across 1 country: Japan

Source: ClinicalTrials.gov record NCT01929655. Inclusion in this directory is not an endorsement.