Radium-223 Dichloride Long-term Follow-up Program

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

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

Study Overview

• Status: Completed
• Conditions: Neoplasm Metastasis / Bone and Bones
• Intervention / Treatment: Other: Data Collection

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: Interventional
• Enrollment (Actual): 255
• Phase: Phase 4

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
    • Westmead, New South Wales, Australia, 2145
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
    • Heidelberg, Victoria, Australia, 3084
• Belgium
  • Kortrijk, Belgium, 8500
  • Leuven, Belgium, 3000
• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90020-090
  • Sao Paulo
    • Barretos/SP, Sao Paulo, Brazil, 14784-400
    • São Paulo, Sao Paulo, Brazil, 01246-000
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
  • Quebec
    • Montreal, Quebec, Canada, H2X 0A9
• Czechia
  • Praha 2, Czechia, 128 08
• Finland
  • Helsinki, Finland, 00290
  • Tampere, Finland, FIN-33520
• France
  • Bordeaux Cedex, France, 33076
  • Nantes, France, 44805
  • Nîmes, France, 30029
  • Saint-Cloud, France, 92210
  • Tours, France, 37044
  • Villejuif, France, 94805
• Germany
  • Berlin, Germany, 10719
  • Berlin, Germany, 12203
  • Bremen, Germany, 28277
  • Baden-Württemberg
    • Ulm, Baden-Württemberg, Germany, 89091
  • Bayern
    • Erlangen, Bayern, Germany, 91054
    • München, Bayern, Germany, 81377
  • Mecklenburg-Vorpommern
    • Rostock, Mecklenburg-Vorpommern, Germany, 18107
  • Nordrhein-Westfalen
    • Aachen, Nordrhein-Westfalen, Germany, 52074
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39120
  • Thüringen
    • Jena, Thüringen, Germany, 07747
• Hong Kong
  • Chai Wan, Hong Kong
• Israel
  • Afula, Israel, 1834111
  • Haifa, Israel, 3109601
  • Jerusalem, Israel, 9112001
  • Petach Tikva, Israel, 4941492
  • Ramat Gan, Israel, 5262000
  • Tel Aviv, Israel, 6423906
  • Zrifin, Israel, 7030000
• Italy
  • Emilia-Romagna
    • Forlì Cesena, Emilia-Romagna, Italy, 47014
    • Modena, Emilia-Romagna, Italy, 41124
  • Lazio
    • Roma, Lazio, Italy, 00161
    • Roma, Lazio, Italy, 00189
  • Lombardia
    • Milano, Lombardia, Italy, 20133
  • Trentino-Alto Adige
    • Trento, Trentino-Alto Adige, Italy, 38100
• Japan
  • Fukuoka, Japan, 811-1395
  • Kumamoto, Japan, 860-0008
  • Miyazaki, Japan, 889-1692
  • Osaka, Japan, 540-0006
  • Ehime
    • Matsuyama, Ehime, Japan, 791-0280
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
    • Sapporo, Hokkaido, Japan, 003-0804
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 920-8641
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 241-8515
    • Yokohama, Kanagawa, Japan, 236-0004
  • Okayama
    • Kurashiki, Okayama, Japan, 701-0192
  • Osaka
    • Osakasayama, Osaka, Japan, 589-8511
  • Saitama
    • Hidaka, Saitama, Japan, 350-1298
    • Kita-Adachigun, Saitama, Japan, 362-0806
  • Tokyo
    • Koto-ku, Tokyo, Japan, 135-8550
• Korea, Republic of
  • Daegu, Korea, Republic of, 42601
  • Incheon, Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
  • Seoul, Korea, Republic of, 3722
  • Seoul Teugbyeolsi
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 6273
    • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 3080
• Norway
  • Bodø, Norway, 8092
  • Oslo, Norway, 0424
• Poland
  • Bialystok, Poland, 15-027
  • Gliwice, Poland, 44-101
  • Warszawa, Poland, 02-781
• Russian Federation
  • Obninsk, Russian Federation, 249036
• Singapore
  • Singapore, Singapore, 119074
  • Singapore, Singapore, 168583
• Spain
  • A Coruña, Spain, 15009
  • Barcelona, Spain, 08036
  • Barcelona, Spain, 08035
  • Barcelona, Spain, 08041
  • Madrid, Spain, 28040
  • Madrid, Spain, 28007
  • Madrid, Spain, 28050
  • Málaga, Spain, 29010
  • Pamplona, Spain, 31008
  • Sevilla, Spain, 41013
  • Sevilla, Spain, 41071
  • Barcelona
    • Badalona (Barcelona), Barcelona, Spain, 08916
  • Illes Baleares
    • Palma De Mallorca, Illes Baleares, Spain, 7120
• Sweden
  • Umea, Sweden, 901 85
• Taiwan
  • Kaohsiung, Taiwan, 81362
  • Taichung, Taiwan, 40705
  • Taipei, Taiwan
  • Taipei, Taiwan, 11217
  • Taoyuan, Taiwan, 33305
• United Kingdom
  • Bristol, United Kingdom, BS2 8ED
  • Cottingham, United Kingdom, HU16 5JQ
  • Cornwall
    • Truro, Cornwall, United Kingdom, TR1 3LJ
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8DH
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S10 2SJ
  • Surrey
    • Guildford, Surrey, United Kingdom, GU2 7XX
    • Sutton, Surrey, United Kingdom, SM2 5PT
  • Warwickshire
    • Coventry, Warwickshire, United Kingdom, CV2 2DX
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99503
  • Arizona
    • Tucson, Arizona, United States, 85704
  • Florida
    • Plantation, Florida, United States, 33324
  • Indiana
    • Indianapolis, Indiana, United States, 46202
  • Kentucky
    • Ashland, Kentucky, United States, 41101
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
    • Shreveport, Louisiana, United States, 71103
  • Maryland
    • Baltimore, Maryland, United States, 21201
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
  • Michigan
    • Detroit, Michigan, United States, 48201
  • Nebraska
    • Omaha, Nebraska, United States, 68130
  • New York
    • Syracuse, New York, United States, 13210
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15215
  • South Dakota
    • Watertown, South Dakota, United States, 57201
  • Washington
    • Seattle, Washington, United States, 98109

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of radium-223 dichloride related Adverse Events		Up to 7 years
Severity of radium-223 dichloride related Adverse Events	Severity will be measured as per guidelines by Common Terminology Criteria for Adverse Events; Version 4.03 (CTCAE)	Up to 7 years
Incidence of radium-223 dichloride related Serious Adverse Events		Up to 7 years
Incidence of placebo-related Adverse Events		Up to 7 years
Severity of placebo-related Adverse Events		Up to 7 years
Incidence of placebo-related Serious Adverse Events		Up to 7 years
Incidence of leukemia		Up to 7 years
Incidence of myelodysplastic syndrome		Up to 7 years
Incidence of aplastic anemia		Up to 7 years
Incidence of primary bone cancer		Up to 7 years
Incidence of any other new primary malignancy		Up to 7 years
Incidence of bone fractures		Up to 7 years
Incidence of bone-associated events		Up to 7 years
Incidence of febrile neutropenia in subjects who receive cytotoxic chemotherapy		Up to 7 years
Incidence of hemorrhage in subjects who receive cytotoxic chemotherapy		Up to 7 years

Collaborators and Investigators

• Sponsor: Bayer
• Investigators: Study Director: Bayer Study Director, Bayer

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2014
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: December 5, 2014
• First Submitted That Met QC Criteria: December 5, 2014
• First Posted (Estimated): December 9, 2014

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: 16996; 2014-002407-25 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No