NCT01565746

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Bayer · Industry
• Sex: Male
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-10-01
• Completion: 2016-04-01
• First posted: 2012-03-29
• Last updated: 2016-10-17

Locations

3 sites across 1 country: Japan