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

NCT01810770 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 243

Last updated 2018-09-19

No results posted yet for this study

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

  • Prostatic Neoplasms

Interventions

DRUG

Radium-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.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-26
Primary Completion
2017-09-25
Completion
2017-09-25

Countries

  • China
  • Singapore
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01810770 on ClinicalTrials.gov