A clinical trial to assess the long term safety of radium-223 dichloride

A Phase 4 long-term follow-up study to define the safety profile of radium-223 dichloride - Radium-223 dichloride long-term follow-up program

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002407-25-DE

Enrollment

800

Registered

2014-10-24

Start date

2014-11-25

Completion date

Unknown

Last updated

2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Castrate Resistant Prostate Cancer/Hormone-Refractory Prostate Cancer, breast cancer or multiple myeloma patients with bone metastasis MedDRA version: 20.1 Level: LLT Classification code 10036916 Term: Prostate cancer stage D System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.1 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl c

Interventions

Trade Name: Xofigo Product Name: Radium RA 223 dichloride Product Code: BAY88-8223 Pharmaceutical Form: Solution for injection INN or Proposed INN: Radium-223 dichloride CAS Number: 444811-40-9 Curren

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 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. 2. Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 400

Exclusion criteria

Exclusion criteria: Not applicable for this study

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 or hemorrhage during their chemotherapy treatment and for up to 6 months thereafter at a frequency based on local clinical practice.;Secondary Objective: N/A;Primary end point(s): -Incidence of and severity of radium-223 dichloride/placebo related AEs -Incidence of radium-223 dichloride/placebo related SAEs -Incidence of leukemia, myelodysplastic syndrome, aplastic anemia, and primary bone cancer or any other new primary malignancy - Incidence of bone fractures and bone associated events (e.g., osteoporosis), regardless of investigator assessment of causality -In subjects who receive cytotoxic chemotherapy: incidence of febrile neutropenia or hemorrhage during their chemotherapy treatment and for up to 6 months thereafter at a frequency based on local clinical practice ;Timepoint(s) of evaluation of this end point: Every 6 months	—

Measure

Time frame

Main Objective: 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 or hemorrhage during their chemotherapy treatment and for up to 6 months thereafter at a frequency based on local clinical practice.;Secondary Objective: N/A;Primary end point(s): -Incidence of and severity of radium-223 dichloride/placebo related AEs -Incidence of radium-223 dichloride/placebo related SAEs -Incidence of leukemia, myelodysplastic syndrome, aplastic anemia, and primary bone cancer or any other new primary malignancy - Incidence of bone fractures and bone associated events (e.g., osteoporosis), regardless of investigator assessment of causality -In subjects who receive cytotoxic chemotherapy: incidence of febrile neutropenia or hemorrhage during their chemotherapy treatment and for up to 6 months thereafter at a frequency based on local clinical practice ;Timepoint(s) of evaluation of this end point: Every 6 months

—

Secondary

Measure	Time frame
Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A	—

Countries

Belgium, Brazil, Canada, Chile, Czech Republic, Finland, France, Germany, Israel, Italy, Japan, Korea, Democratic People's Republic of, Netherlands, Norway, Poland, Russian Federation, Singapore, Spain, Sweden, Taiwan, United Kingdom, United States

Contacts

Public ContactBayer Clinical Trials Contact

Bayer AG

clinical-trials-contact@bayer.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026