check_circleStudy Completed

Neoplasm Metastasis

Dose escalation study of radium-223 dichloride in patients with advanced skeletal metastases

Trial purpose

A new bone-seeking radiopharmaceutical drug, called Radium-223 dichloride (formerly known as "Alpharadin"), is currently under development. It is an injectable aqueous solution containing radium-223, a radionuclide that emits radiation of another quality and with a different distribution than radiopharmaceuticals currently in use.
After injection of the drug into the blood, a large portion of the drug will accumulate in the bones, and irradiate the skeletal metastases. The drug is expected to be retained longer in the painful sites of bone than in other sites of the body, and may alleviate pain through its radiation. Radium-223 is expected to be both efficacious as regards the targeted localised irradiation, and also to have a favourable safety profile.
The radiopharmaceutical drug Radium-223 has not been given to humans before. In this first clinical study in man, a so-called phase I study, the safety, tolerance and the toxicity of various radioactivity doses of Radium-223 will be evaluated.

Key Participants Requirements

Sex

Both

Age

30 - N/A

Trial summary

Enrollment Goal
31
Trial Dates
August 2001 - June 2003
Phase
Phase 1
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Karolinska University HospitalStockholm, Sweden
Completed
The Norwegian Radium HospitalOslo, Norway
Completed
University Hospital of North NorwayTromsoe, Norway

Primary Outcome

  • Number of participants with predetermined adverse events (dose limiting toxicity [DLT]) as a measure of safety and tolerability while dose escalating
    date_rangeTime Frame:
    Up to 8 weeks from injection
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Blood clearance of radioactivity
    date_rangeTime Frame:
    48 hours after the last injection
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    Safety Issue:
    Yes
  • Quality of Life Questionnaire
    date_rangeTime Frame:
    8 weeks after the last injection
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    Safety Issue:
    No

Trial design

A phase I open-label, multicenter, dose-escalating study of radium-223 in patients with advanced skeletal metastases
Trial Type
Interventional
Intervention Type
Radiation
Trial Purpose
Other
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1