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Trial record 1 of 1 for:    NCT02312960
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Radium-223 Dichloride Long-term Follow-up Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02312960
Recruitment Status : Active, not recruiting
First Posted : December 9, 2014
Last Update Posted : March 2, 2023
Sponsor:
Information provided by (Responsible Party):
Bayer

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

Condition or disease Intervention/treatment Phase
Neoplasm Metastasis / Bone and Bones Other: Data Collection Phase 4

Detailed 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 258 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 4 Long-term Follow-up Study to Define the Safety Profile of Radium-223 Dichloride
Actual Study Start Date : December 18, 2014
Estimated Primary Completion Date : February 7, 2024
Estimated Study Completion Date : February 7, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Arm 1
The subjects previously enrolled in a selected radium-223 dichloride feeder trial, their treating health care professional, or caregiver will be contacted in 6-month intervals for follow up and query.
 Other: Data Collection
No study treatment will be provided in this long term follow up study.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of radium-223 dichloride related Adverse Events [ Time Frame: Up to 7 years ]
  2. Severity of radium-223 dichloride related Adverse Events [ 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. Incidence of radium-223 dichloride related Serious Adverse Events [ Time Frame: Up to 7 years ]
  4. Incidence of placebo-related Adverse Events [ Time Frame: Up to 7 years ]
  5. Severity of placebo-related Adverse Events [ Time Frame: Up to 7 years ]
  6. Incidence of placebo-related Serious Adverse Events [ Time Frame: Up to 7 years ]
  7. Incidence of leukemia [ Time Frame: Up to 7 years ]
  8. Incidence of myelodysplastic syndrome [ Time Frame: Up to 7 years ]
  9. Incidence of aplastic anemia [ Time Frame: Up to 7 years ]
  10. Incidence of primary bone cancer [ Time Frame: Up to 7 years ]
  11. Incidence of any other new primary malignancy [ Time Frame: Up to 7 years ]
  12. Incidence of bone fractures [ Time Frame: Up to 7 years ]
  13. Incidence of bone-associated events [ Time Frame: Up to 7 years ]
  14. Incidence of febrile neutropenia in subjects who receive cytotoxic chemotherapy [ Time Frame: Up to 7 years ]
  15. Incidence of hemorrhage in subjects who receive cytotoxic chemotherapy [ Time Frame: Up to 7 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02312960


Locations
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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02312960    
Other Study ID Numbers: 16996
2014-002407-25 ( EudraCT Number )
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: March 2, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes