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

• Register: EUCTR
• Last refreshed on: 12 March 2024
• Main ID: EUCTR2014-002407-25-DE
• Date of registration: 24/10/2014
• Prospective Registration: Yes
• Primary sponsor: Bayer AG
• Public title: A clinical trial to assess the long term safety of radium-223 dichloride
• Scientific title: 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
• Date of first enrolment: 25/11/2014
• Target sample size: 800
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002407-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

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

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer AG

• Name: Bayer Clinical Trials Contact
• Affiliation: Bayer AG

Key inclusion & exclusion 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:
Not applicable for this study


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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 cysts and polyps)
MedDRA version: 20.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

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
Current Sponsor code: BAY 88-8223
Other descriptive name: RADIUM RA 223 DICHLORIDE
Concentration unit: kBq/ml kilobecquerel(s)/millilitre
Concentration type: equal
Concentration number: 1000-

Primary Outcome(s)

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.

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

Secondary Objective: N/A

Timepoint(s) of evaluation of this end point: Every 6 months

Secondary Outcome(s)

Secondary end point(s): N/A

Timepoint(s) of evaluation of this end point: N/A

Secondary ID(s)

16996

Source(s) of Monetary Support

Bayer AG

Ethics review

Status: Approved
Approval date: 25/11/2014
Contact: