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Trial record 1 of 1 for:    A Phase 4 long-term follow-up study to define the safety profile of radium-223 dichloride
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02312960
Recruitment Status : Recruiting
First Posted : December 9, 2014
Last Update Posted : May 20, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE December 5, 2014
First Posted Date  ICMJE December 9, 2014
Last Update Posted Date May 20, 2020
Actual Study Start Date  ICMJE December 18, 2014
Estimated Primary Completion Date October 23, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
  • Incidence of radium-223 dichloride related Adverse Events [ Time Frame: Up to 7 years ]
  • 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)
  • Incidence of radium-223 dichloride related Serious Adverse Events [ Time Frame: Up to 7 years ]
  • Incidence of placebo-related Adverse Events [ Time Frame: Up to 7 years ]
  • Severity of placebo-related Adverse Events [ Time Frame: Up to 7 years ]
  • Incidence of placebo-related Serious Adverse Events [ Time Frame: Up to 7 years ]
  • Incidence of leukemia [ Time Frame: Up to 7 years ]
  • Incidence of myelodysplastic syndrome [ Time Frame: Up to 7 years ]
  • Incidence of aplastic anemia [ Time Frame: Up to 7 years ]
  • Incidence of primary bone cancer [ Time Frame: Up to 7 years ]
  • Incidence of any other new primary malignancy [ Time Frame: Up to 7 years ]
  • Incidence of bone fractures [ Time Frame: Up to 7 years ]
  • Incidence of bone-associated events [ Time Frame: Up to 7 years ]
  • Incidence of febrile neutropenia in subjects who receive cytotoxic chemotherapy [ Time Frame: Up to 7 years ]
  • Incidence of hemorrhage in subjects who receive cytotoxic chemotherapy [ Time Frame: Up to 7 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 5, 2014)
  • Incidence of radium 223 dichloride related Adverse Events (AEs) [ Time Frame: Up to 7 years ]
  • Severity of radium 223 dichloride 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)
  • Incidence of radium 223 dichloride related Serious Adverse Events (SAEs) [ Time Frame: Up to 7 years ]
  • Incidence of leukemia [ Time Frame: Up to 7 years ]
  • Incidence of myelodysplastic syndrome [ Time Frame: Up to 7 years ]
  • Incidence of aplastic anemia [ Time Frame: Up to 7 years ]
  • Incidence of primary bone cancer [ Time Frame: Up to 7 years ]
  • Incidence of any other new primary malignancy [ Time Frame: Up to 7 years ]
  • Incidence of febrile neutropenia in subjects who receive cytotoxic chemotherapy [ Time Frame: Up to 7 years ]
  • Incidence of hemorrhage in subjects who receive cytotoxic chemotherapy [ Time Frame: Up to 7 years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2014)
Overall Survival (OS) [ Time Frame: Up to 7 years ]
OS defined as the time in days from the subject's applicable feeder trial start date to the date of death due to any cause
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radium-223 Dichloride Long-term Follow-up Program
Official Title  ICMJE A Phase 4 Long-term Follow-up Study to Define the Safety Profile of Radium-223 Dichloride
Brief Summary Patients will be followed up in this study after prior treatment with BAY88-8223 / Radium-223 dichloride / Xofigo .
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Neoplasm Metastasis / Bone and Bones
Intervention  ICMJE Other: Data Collection
No study treatment will be provided in this long term follow up study.
Study Arms  ICMJE 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.
Intervention: Other: Data Collection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2014)
800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 23, 2023
Estimated Primary Completion Date October 23, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Chile,   Czechia,   Finland,   France,   Germany,   Israel,   Italy,   Japan,   Korea, Republic of,   Norway,   Poland,   Russian Federation,   Singapore,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02312960
Other Study ID Numbers  ICMJE 16996
2014-002407-25 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP