PK in Pts With HRPC & Skeletal Metastes

Prostatic Neoplasms Clinical Trial

Official title: A Phase I, Open-label, Dosimetry, Biodistribution and Pharmacokinetic Study of Alpharadin™ in Patients With Hormone Refractory Prostate Cancer and Skeletal Metastases

Status Completed

Clinical Trial Summary

Primary objective: To investigate the biodistribution, radiation dosimetry, and pharmacokinetics of two separate intravenous (IV) injections of Xofigo (100 kBq/kg body weight [b.w.] [=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization], 6 weeks apart).

Secondary objectives: To determine the safety of IV injections of Xofigo after two separate injections (6 weeks apart), to evaluate treatment response (antitumour effect in osteoblastic bone metastases) of Xofigo treatment consisting of two injections of activity 100 kBq/kg b.w. (=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization), 6 weeks apart and to evaluate long term radiation toxicity and to collect survival data at 6 and 12 months after the first injection

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Prostatic Neoplasms

• NCT number: NCT00667537
• Study type: Interventional
• Source: Bayer
• Status: Completed
• Phase: Phase 1
• Start date: July 2007
• Completion date: December 2008