Radium-223 Dichloride Long-term Follow-up Program

Study at a glance

From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

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

ClinicalTrials.gov ID

NCT02312960

Acronym / sponsor ID

16996

Conditions

Neoplasm Metastasis / Bone and Bones

Phase

Phase 4

Study type

Interventional

Recruitment status

Completed

Enrolment

255 participants (actual)

Lead sponsor

BayerIndustry (pharma, biotech, devices)

Study start

18 Dec 2014 (actual)

Primary completion

31 Jan 2024 (actual)

Study completion

31 Jan 2024 (actual)

First posted

9 Dec 2014 (estimated)

Results

Posted 30 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Other

Allocation

Not applicable

Intervention model

Single group

Masking

None (open label)

Number of arms

1

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Click here to find information about studies related to Bayer Healthcare products conducted in EuropeLink provided by the sponsor.
• Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Related trials for Neoplasm Metastasis / Bone and Bones

• RecruitingPhase 3

  Fight Osteosarcoma Through European Research Evolving Study Platform From Diagnosis to Relapse

  Osteosarcoma, Pediatric Osteosarcoma

• Active, not recruitingPhase 3

  Immunotherapy With Nivolumab and Ipilimumab Followed by Nivolumab or Nivolumab With Cabozantinib for Patients With Advanced Kidney Cancer, The PDIGREE Study

  Clear Cell Renal Cell Carcinoma, Metastatic Malignant Neoplasm in the Bone

• Active, not recruitingPhase 1/2

  Avelumab, Utomilumab, Anti-OX40 Antibody PF-04518600, and Radiation Therapy in Treating Patients With Advanced Malignancies

  Advanced Malignant Solid Neoplasm, Castration-Resistant Prostate Carcinoma

• Active, not recruitingObservational study

  Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant

  Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia

• Active, not recruitingPhase 3

  Combination Chemotherapy With or Without Ganitumab in Treating Patients With Newly Diagnosed Metastatic Ewing Sarcoma

  Metastatic Ewing Sarcoma, Metastatic Malignant Neoplasm in the Bone

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

117 sites in 22 countries: see every site and its status.