Radium-223 Dichloride Long-term Follow-up Program



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:December 18, 2014
End Date:September 15, 2025
Contact:Bayer Clinical Trials Contact
Email:clinical-trials-contact@bayer.com
Phone:(+)1-888-84 22937

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A Phase 4 Long-term Follow-up Study to Define the Safety Profile of Radium-223 Dichloride

Patients will be followed up in this study after prior treatment with BAY 88-8223 /
Radium-223 dichloride / Xofigo .

This long-term follow up study will enroll subjects who will be transferred from selected
interventional, company sponsored trials with radium-223 dichloride (feeder trials).

The primary objectives are to define the long term safety profile of radium-223 dichloride
(for up to 7 years after the last dose of radium-223 dichloride); to assess the incidence of
leukemia, myelodysplastic syndrome, aplastic anemia, and primary bone cancer or any other new
primary malignancy; to assess the incidence of bone fractures and bone associated events
(e.g., osteoporosis); and, in subjects who receive cytotoxic chemotherapy, to assess the
incidence of febrile neutropenia and hemorrhage during their chemotherapy treatment and for
up to 6 months thereafter at a frequency based on local clinical practice.

Inclusion Criteria:

- Subject was previously enrolled in a selected company sponsored feeder trial, and has
received at least 1 dose of radium 223 dichloride or placebo in the feeder trial

Exclusion Criteria:

- Not applicable to this follow up study
We found this trial at
10
sites
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Detroit, MI
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Darlinghurst,
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Indianapolis, IN
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New Orleans, LA
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Omaha, NE
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Plantation, FL
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Shreveport, LA
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Syracuse, NY
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Tucson, AZ
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