Radium-223 Dichloride Long-term Follow-up Program

Bayer

Status and phase: Completed; Phase 4

Conditions: Neoplasm Metastasis / Bone and Bones

Treatments: Other: Data Collection

Study type: Interventional

Funder types: Industry

Identifiers

NCT02312960

2014-002407-25 (EudraCT Number)

16996

Details and patient eligibility

About

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

Full 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.

Enrollment: 255 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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255 participants in 1 patient group

Arm 1

Other group

Description:

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.

Treatment:

Other: Data Collection