Radium-223 Dichloride Long-term Follow-up Program

Neoplasm Metastasis / Bone and Bones Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312960
• Other study ID #: 16996
• Secondary ID: 2014-002407-25
• Status: Completed
• Phase: Phase 4
• Start date: December 18, 2014
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 255
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neoplasm Metastasis / Bone and Bones

Intervention

Other:
• Data Collection
No study treatment will be provided in this long term follow up study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Czechia,  Finland,  France,  Germany,  Hong Kong,  Israel,  Italy,  Japan,  Korea, Republic of,  Norway,  Poland,  Russian Federation,  Singapore,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of radium-223 dichloride related Adverse Events		Up to 7 years
Primary	Severity of radium-223 dichloride related Adverse Events	Severity will be measured as per guidelines by Common Terminology Criteria for Adverse Events; Version 4.03 (CTCAE)	Up to 7 years
Primary	Incidence of radium-223 dichloride related Serious Adverse Events		Up to 7 years
Primary	Incidence of placebo-related Adverse Events		Up to 7 years
Primary	Severity of placebo-related Adverse Events		Up to 7 years
Primary	Incidence of placebo-related Serious Adverse Events		Up to 7 years
Primary	Incidence of leukemia		Up to 7 years
Primary	Incidence of myelodysplastic syndrome		Up to 7 years
Primary	Incidence of aplastic anemia		Up to 7 years
Primary	Incidence of primary bone cancer		Up to 7 years
Primary	Incidence of any other new primary malignancy		Up to 7 years
Primary	Incidence of bone fractures		Up to 7 years
Primary	Incidence of bone-associated events		Up to 7 years
Primary	Incidence of febrile neutropenia in subjects who receive cytotoxic chemotherapy		Up to 7 years
Primary	Incidence of hemorrhage in subjects who receive cytotoxic chemotherapy		Up to 7 years