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 Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy Up to 7 years Number of Participants With Any Other New Primary Malignancy Up to 7 years Number of Participants With Bone Fractures Up to 7 years Number of Participants With Bone-associated Events Up to 7 years Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy Up to 7 years Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) Up to 7 years Adverse events considered related to radium-223 dichloride or placebo (received in the feeder studies), first arising or worsening on or after the date the participant signed the 16996 informed consent.
Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs) Up to 7 years Severity will be measured as per guidelines by Common Terminology Criteria for Adverse Events; Version 4.03 (CTCAE)
Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events Up to 7 years Serious adverse events considered related to radium-223 dichloride or placebo (received in the feeder studies), first arising or worsening on or after the date the participant signed the 16996 informed consent.
Number of Participants With Leukemia Up to 7 years Number of Participants With Myelodysplastic Syndrome Up to 7 years Number of Participants With Aplastic Anemia Up to 7 years Number of Participants With Primary Bone Cancer Up to 7 years
- Secondary Outcome Measures
Name Time Method