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PK in Pts With HRPC & Skeletal Metastes

NCT00667537 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2015-12-14

No results posted yet for this study

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

Conditions

  • Prostatic Neoplasms

Interventions

DRUG

Radium-223 chloride (Xofigo®, BAY88-8223) injection

Sterile, clear and colourless aqueous solution of radium-223 chloride free of endotoxins, for intravenous administration

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United Kingdom

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 NCT00667537 on ClinicalTrials.gov