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Safety, Biodistribution, Radiation Dosimetry and Pharmacokinetics Study of BAY88-8223 in Japanese Patients

NCT01565746 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2016-10-17

No results posted yet for this study

Summary

This is an uncontrolled, open-label, non-randomized Phase I study to investigate safety, biodistribution, radiation dosimetry and pharmacokinetics of a single dose of BAY88-8223 in Japanese patients with castration-resistant prostate cancer and bone metastases.

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

Radium-223 dichloride (Xofigo, BAY88-8223)

Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg

DRUG

Radium-223 dichloride (Xofigo, BAY88-8223)

Radium-223 dichloride (Xofigo, BAY88-8223) 100 kBq/kg

DRUG

Radium-223 dichloride (Xofigo, BAY88-8223)

Expansion arm: Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2012-10-31
Completion
2016-04-30

Countries

  • Japan

Study Locations

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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 NCT01565746 on ClinicalTrials.gov