Radium-223 Dichloride Long-term Follow-up Program

Official Title

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

Summary:

Patients will be followed up in this study after prior treatment with BAY88-8223 / Radium-223 dichloride / Xofigo .

Trial Description

Primary Outcome Measures :

• Incidence of radium-223 dichloride related Adverse Events
• Severity of radium-223 dichloride related Adverse Events
• Incidence of radium-223 dichloride related Serious Adverse Events
• Incidence of placebo-related Adverse Events
• Severity of placebo-related Adverse Events
• Incidence of placebo-related Serious Adverse Events
• Incidence of leukemia
• Incidence of myelodysplastic syndrome
• Incidence of aplastic anemia
• Incidence of primary bone cancer [ Time Frame: Up to 7 years ]Incidence of any other new primary malignancy
• Incidence of bone fractures
• Incidence of bone-associated events
• Incidence of febrile neutropenia in subjects who receive cytotoxic chemotherapy [ Time Frame: Up to 7 years

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.

View this trial on ClinicalTrials.gov