Trial Condition(s):
Neoplasm Metastasis / Bone and Bones
Radium-223 dichloride long-term follow-up program
Bayer Identifier:
16996
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
Patients will be followed up in this study after prior treatment with BAY88-8223 / Radium-223 dichloride / Xofigo .
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Obninsk, Russia, 249036 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Berlin, Germany, 12203 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Bremen, Germany, 28277 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Erlangen, Germany, 91054 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Rostock, Germany, 18107 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Ulm, Germany, 89091 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Mainz, Germany, 55131 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Berlin, Germany, 10719 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Jena, Germany, 07747 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Aachen, Germany, 52074 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site München, Germany, 81377 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Magdeburg, Germany, 39120 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Dresden, Germany, 01307 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Forlì Cesena, Italy, 47014 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Haifa, Israel, 3109601 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Petach Tikva, Israel, 4941492 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Seoul, South Korea, 06273 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Seoul, South Korea, 03722 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Seoul, South Korea, 05505 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Barcelona, Spain, 08041 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Jerusalem, Israel, 9112001 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Ramat Gan, Israel, 5262000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Afula, Israel, 1834111 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Tel Aviv, Israel, 6423906 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site VILLEJUIF, France, 94805 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sheffield, United Kingdom, S10 2SJ | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Bristol, United Kingdom, BS2 8ED | Status Not yet recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Truro, United Kingdom, TR1 3LJ | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Cottingham, United Kingdom, HU16 5JQ | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site PLYMOUTH, United Kingdom, PL6 8DH | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site LEUVEN, Belgium, 3000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site KORTRIJK, Belgium, 8500 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Singapore, Singapore, 119074 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Singapore, Singapore, 168583 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Montreal, Canada, H2X 0A9 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Osakasayama, Japan, 589-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Hidaka, Japan, 350-1298 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Osaka, Japan, 540-0006 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sapporo, Japan, 060-8648 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kita-Adachigun, Japan, 362-0806 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site NIMES cedex 9, France, 30029 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site TOURS, France, 37044 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Syracuse, United States, 13210 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site New Orleans, United States, 70112 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Omaha, United States, 68130 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Indianapolis, United States, 46202 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Pittsburgh, United States, 15215 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Plantation, United States, 33324 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Tucson, United States, 85704 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Shreveport, United States, 71103 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Detroit, United States, 48201 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Oslo, Norway, 0424 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Darlinghurst, Australia, 2010 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Heidelberg, Australia, 3084 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Westmead, Australia, 2145 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Taipei, Taiwan, China, 11217 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kaohsiung, Taiwan, China, 81362 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Praha 2, Czech Republic, 128 08 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site A Coruña, Spain, 15009 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Seoul, South Korea, 03080 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sevilla, Spain, 41013 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Taoyuan, Taiwan, China, 33305 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Madrid, Spain, 28050 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Zrifin, Israel, 7030000 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Incheon, South Korea | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Roma, Italy, 00161 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Modena, Italy, 41124 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Trento, Italy, 38100 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Roma, Italy, 00189 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Watertown, United States, 57201 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Ashland, United States, 41101 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Madrid, Spain, 28040 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site SAINT CLOUD, France, 92210 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Palma De Mallorca, Spain, 7120 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Tampere, Finland, FIN-33520 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Barcelona, Spain, 08035 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Milano, Italy, 20133 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Warszawa, Poland, 02-781 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site BARCELONA, Spain, 08036 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Miyazaki, Japan, 889-1692 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kurashiki, Japan, 701-0192 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Koto-ku, Japan, 135-8550 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kumamoto, Japan, 860-0008 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Kanazawa, Japan, 920-8641 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Yokohama, Japan, 241-8515 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Yokohama, Japan, 236-0004 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sapporo, Japan, 003-0804 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Matsuyama, Japan, 791-0280 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Badalona (Barcelona), Spain, 08916 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Pamplona, Spain, 31008 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sevilla, Spain, 41071 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Málaga, Spain, 29010 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Madrid, Spain, 28007 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site BORDEAUX CEDEX, France, 33076 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site NANTES, France, 44805 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Bialystok, Poland, 15-027 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Fukuoka, Japan, 811-1395 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Helsinki, Finland, 00290 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Bodø, Norway, 8092 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Anchorage, United States, 99503 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Taichung, Taiwan, China, 40705 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Taipei, Taiwan, China | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Guildford, United Kingdom, GU2 7XX | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Sutton, United Kingdom, SM2 5PT | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Coventry, United Kingdom, CV2 2DX | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Seattle, United States, 98109 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Daegu, South Korea, 42601 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Fitzroy, Australia, 3065 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Gliwice, Poland, 44-101 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site São Paulo, Brazil, 01246-000 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Barretos/SP, Brazil, 14784-400 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Porto Alegre, Brazil, 90020-090 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Umeå, Sweden, 901 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Toronto, Canada, M4N 3M5 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Boston, United States, 02114 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Baltimore, United States, 21201 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Investigative Site Chai Wan, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
A Phase 4 long-term follow-up study to define the safety profile of radium-223 dichloride
Trial Type:
Interventional
Intervention Type:
Other
Trial Purpose:
Other
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Incidence of radium-223 dichloride related Adverse EventsTimeframe: Up to 7 years
- Severity of radium-223 dichloride related Adverse EventsSeverity will be measured as per guidelines by Common Terminology Criteria for Adverse Events; Version 4.03 (CTCAE)Timeframe: Up to 7 years
- Incidence of radium-223 dichloride related Serious Adverse EventsTimeframe: Up to 7 years
- Incidence of placebo-related Adverse EventsTimeframe: Up to 7 years
- Severity of placebo-related Adverse EventsTimeframe: Up to 7 years
- Incidence of placebo-related Serious Adverse EventsTimeframe: Up to 7 years
- Incidence of leukemiaTimeframe: Up to 7 years
- Incidence of myelodysplastic syndromeTimeframe: Up to 7 years
- Incidence of aplastic anemiaTimeframe: Up to 7 years
- Incidence of primary bone cancerTimeframe: Up to 7 years
- Incidence of any other new primary malignancyTimeframe: Up to 7 years
- Incidence of bone fracturesTimeframe: Up to 7 years
- Incidence of bone-associated eventsTimeframe: Up to 7 years
- Incidence of febrile neutropenia in subjects who receive cytotoxic chemotherapyTimeframe: Up to 7 years
- Incidence of hemorrhage in subjects who receive cytotoxic chemotherapyTimeframe: Up to 7 years
Additional Information
Not Available
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