Radium-223 Dichloride Long-term Follow-up Program
- Conditions
- Neoplasm Metastasis / Bone and Bones
- Interventions
- Other: Data Collection
- Registration Number
- NCT02312960
- Lead Sponsor
- Bayer
- Brief Summary
Patients will be followed up in this study after prior treatment with BAY88-8223 / Radium-223 dichloride / Xofigo .
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 255
- 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
- Not applicable to this follow up study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1 Data Collection The subjects previously enrolled in a selected radium-223 dichloride feeder trial, their treating health care professional, or caregiver will be contacted in 6-month intervals for follow up and query.
- Primary Outcome Measures
Name Time Method Incidence of primary bone cancer Up to 7 years Incidence of placebo-related Adverse Events Up to 7 years Incidence of placebo-related Serious Adverse Events Up to 7 years Incidence of leukemia Up to 7 years Incidence of bone fractures Up to 7 years Incidence of radium-223 dichloride related Adverse Events Up to 7 years Severity of radium-223 dichloride related Adverse Events Up to 7 years Severity will be measured as per guidelines by Common Terminology Criteria for Adverse Events; Version 4.03 (CTCAE)
Incidence of hemorrhage in subjects who receive cytotoxic chemotherapy Up to 7 years Incidence of myelodysplastic syndrome Up to 7 years Incidence of aplastic anemia Up to 7 years Incidence of radium-223 dichloride related Serious Adverse Events Up to 7 years Severity of placebo-related Adverse Events Up to 7 years Incidence of any other new primary malignancy Up to 7 years Incidence of bone-associated events Up to 7 years Incidence of febrile neutropenia in subjects who receive cytotoxic chemotherapy Up to 7 years
- Secondary Outcome Measures
Name Time Method