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Completed

NCT Number: NCT02312960

Radium-223 Dichloride Long-term Follow-up Program

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

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Key information

Conditions

Neoplasm Metastasis / Bone and Bones Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Darlinghurst, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

No study treatment will be provided in this long term follow up study.

Primary outcomes

  1. Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs)

    Time frame: 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.

  2. Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs)

    Time frame: Up to 7 years

    Severity will be measured as per guidelines by Common Terminology Criteria for Adverse Events; Version 4.03 (CTCAE)

  3. Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events

    Time frame: 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.

  4. Number of Participants With Leukemia

    Time frame: Up to 7 years

  5. Number of Participants With Myelodysplastic Syndrome

    Time frame: Up to 7 years

  6. Number of Participants With Aplastic Anemia

    Time frame: Up to 7 years

  7. Number of Participants With Primary Bone Cancer

    Time frame: Up to 7 years

  8. Number of Participants With Any Other New Primary Malignancy

    Time frame: Up to 7 years

  9. Number of Participants With Bone Fractures

    Time frame: Up to 7 years

  10. Number of Participants With Bone-associated Events

    Time frame: Up to 7 years

  11. Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy

    Time frame: Up to 7 years

  12. Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy

    Time frame: Up to 7 years

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2024
Study completion
2024
First posted
Dec 9, 2014
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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