Neoplasm Metastasis Clinical Trial
Official title:
A Phase I Open-label, Multicenter, Dose-escalating Study of Radium-223 in Patients With Advanced Skeletal Metastases
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.
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