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Brief Title: Dose Escalation Study of Radium-223 Dichloride in Patients With Advanced Skeletal Metastases
Official Title: A Phase I Open-label, Multicenter, Dose-escalating Study of Radium-223 in Patients With Advanced Skeletal Metastases
Study ID: NCT01798108
Brief Summary: 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.
Detailed Description:
Minimum Age: 30 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Norwegian Radium Hospital, Oslo, , Norway
University Hospital of North Norway, Tromsoe, , Norway
Karolinska University Hospital, Stockholm, , Sweden
Name: Bayer Study Director
Affiliation: Bayer
Role: STUDY_DIRECTOR