check_circleStudy Completed

Neoplasm Metastasis / Bone and Bones

Bayer Identifier:

16996

ClinicalTrials.gov Identifier:

NCT02312960

EudraCT Number:

2014-002407-25

EU CT Number:

Not Available
Radium-223 dichloride long-term follow-up program

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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

  • - Not applicable to this follow up study

Trial summary

Enrollment Goal
255
Trial Dates
December 2014 - January 2024
Phase
Phase 4
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Obninsk, 249036, Russian Federation
Withdrawn
Moscow, 115478, Russian Federation
Completed
Berlin, 12203, Germany
Completed
Bremen, 28277, Germany
Completed
Erlangen, 91054, Germany
Withdrawn
Hamburg, 20246, Germany
Completed
Rostock, 18107, Germany
Completed
Ulm, 89091, Germany
Completed
Mainz, 55131, Germany
Withdrawn
Freiburg im Breisgau, 79106, Germany
Completed
Berlin, 10719, Germany
Completed
Jena, 07747, Germany
Completed
Aachen, 52074, Germany
Completed
München, 81377, Germany
Withdrawn
Tübingen, 72076, Germany
Completed
Magdeburg, 39120, Germany
Completed
Dresden, 01307, Germany
Completed
Forlì Cesena, 47014, Italy
Withdrawn
Kfar Saba, 4428164, Israel
Completed
Haifa, 3109601, Israel
Completed
Petach Tikva, 4941492, Israel
Completed
Seoul, 6273, Korea, Republic Of
Withdrawn
Seoul, 137-701, Korea, Republic Of
Completed
Seoul, 3722, Korea, Republic Of
Completed
Seoul, 138-736, Korea, Republic Of
Withdrawn
München, 81675, Germany
Withdrawn
Torino, 10043, Italy
Withdrawn
Santiago, 7500921, Chile
Withdrawn
Busan, 49241, Korea, Republic Of
Withdrawn
Madrid, 28041, Spain
Completed
Barcelona, 08041, Spain
Withdrawn
Beer Sheva, 8410101, Israel
Withdrawn
Jerusalem, 9372212, Israel
Completed
Jerusalem, 9112001, Israel
Completed
Ramat Gan, 5262000, Israel
Completed
Afula, 1834111, Israel
Completed
Tel Aviv, 6423906, Israel
Completed
VILLEJUIF, 94805, France
Completed
Sheffield, S10 2SJ, United Kingdom
Withdrawn
Taunton, TA1 5DA, United Kingdom
Not yet recruiting
Bristol, BS2 8ED, United Kingdom
Completed
Truro, TR1 3LJ, United Kingdom
Withdrawn
Nottingham, NG5 1PB, United Kingdom
Completed
Cottingham, HU16 5JQ, United Kingdom
Completed
PLYMOUTH, PL6 8DH, United Kingdom
Completed
LEUVEN, 3000, Belgium
Withdrawn
EDEGEM, 2650, Belgium
Withdrawn
Bruxelles, 1070, Belgium
Completed
KORTRIJK, 8500, Belgium
Completed
Singapore, 119074, Singapore
Completed
Singapore, 168583, Singapore
Completed
Montreal, H2X 0A9, Canada
Completed
Osakasayama, 589-8511, Japan
Completed
Hidaka, 350-1298, Japan
Completed
Osaka, 540-0006, Japan
Completed
Sapporo, 060-8648, Japan
Completed
Kita-Adachigun, 362-0806, Japan
Completed
Nîmes, 30029, France
Completed
TOURS, 37044, France
Completed
Syracuse, 13210, United States
Completed
New Orleans, 70112, United States
Completed
Omaha, 68130, United States
Completed
Indianapolis, 46202, United States
Completed
Pittsburgh, 15215, United States
Completed
Plantation, 33324, United States
Completed
Tucson, 85704, United States
Completed
Shreveport, 71103, United States
Completed
Detroit, 48201, United States
Completed
Oslo, 0424, Norway
Completed
Darlinghurst, 2010, Australia
Completed
Heidelberg, 3084, Australia
Completed
Westmead, 2145, Australia
Completed
Taipei, 11217, Taiwan
Completed
Kaohsiung, 81362, Taiwan
Completed
Praha 2, 128 08, Czechia
Completed
Seoul, 138-736, Korea, Republic Of
Completed
A Coruña, 15009, Spain
Completed
Seoul, 3080, Korea, Republic Of
Completed
Sevilla, 41013, Spain
Completed
Taoyuan, 33305, Taiwan
Completed
Madrid, 28050, Spain
Completed
Zrifin, 7030000, Israel
Completed
Incheon, Korea, Republic Of
Completed
Roma, 00161, Italy
Completed
Modena, 41124, Italy
Withdrawn
Bologna, 40138, Italy
Completed
Trento, 38100, Italy
Completed
Roma, 00189, Italy
Withdrawn
Milano, 20141, Italy
Withdrawn
Cagliari, 09125, Italy
Completed
Watertown, 57201, United States
Completed
Ashland, 41101, United States
Completed
Madrid, 28040, Spain
Completed
Saint-Cloud, 92210, France
Completed
Palma De Mallorca, 7120, Spain
Completed
Tampere, FIN-33520, Finland
Completed
Barcelona, 08035, Spain
Completed
Milano, 20133, Italy
Completed
Warszawa, 02-781, Poland
Completed
BARCELONA, 08036, Spain
Completed
Miyazaki, 889-1692, Japan
Completed
Kurashiki, 701-0192, Japan
Withdrawn
Fukuoka, 812-8582, Japan
Withdrawn
Sendai, 980-8574, Japan
Withdrawn
Bunkyo-ku, 113-8431, Japan
Completed
Koto-ku, 135-8550, Japan
Withdrawn
Osakasayama, 589-8511, Japan
Completed
Kumamoto, 860-0008, Japan
Completed
Kanazawa, 920-8641, Japan
Withdrawn
Bunkyo-ku, 113-8603, Japan
Completed
Yokohama, 241-8515, Japan
Withdrawn
Chiba, 260-8677, Japan
Withdrawn
Chiba, 260-8717, Japan
Completed
Yokohama, 236-0004, Japan
Completed
Sapporo, 003-0804, Japan
Completed
Matsuyama, 791-0280, Japan
Completed
Badalona (Barcelona), 08916, Spain
Completed
Pamplona, 31008, Spain
Completed
Sevilla, 41071, Spain
Completed
Málaga, 29010, Spain
Completed
Madrid, 28007, Spain
Withdrawn
POITIERS, 86021, France
Withdrawn
TOULOUSE CEDEX 9, 31059, France
Completed
BORDEAUX CEDEX, 33076, France
Completed
NANTES, 44805, France
Completed
Bialystok, 15-027, Poland
Completed
Fukuoka, 811-1395, Japan
Completed
Helsinki, 00290, Finland
Withdrawn
Madrid, 28033, Spain
Completed
Madrid, 28050, Spain
Completed
Bodø, 8092, Norway
Completed
Anchorage, 99503, United States
Completed
Taichung, 40705, Taiwan
Withdrawn
Taipei, Taiwan
Completed
Taipei, Taiwan
Completed
Guildford, GU2 7XX, United Kingdom
Withdrawn
Belfast, BT9 7AB, United Kingdom
Completed
Sutton, SM2 5PT, United Kingdom
Completed
Coventry, CV2 2DX, United Kingdom
Completed
Seattle, 98109, United States
Completed
Daegu, 42601, Korea, Republic Of
Completed
Fitzroy, 3065, Australia
Completed
Gliwice, 44-101, Poland
Withdrawn
Gdynia, 81-519, Poland
Withdrawn
Belo Horizonte, 30130-090, Brazil
Completed
São Paulo, 01246-000, Brazil
Completed
Barretos/SP, 14784-400, Brazil
Completed
Porto Alegre, 90020-090, Brazil
Withdrawn
Kuopio, 70210, Finland
Completed
Umea, 901 85, Sweden
Withdrawn
Lørenskog, 1478, Norway
Withdrawn
Oslo, 0424, Norway
Completed
Toronto, M4N 3M5, Canada
Withdrawn
Adelaide, 5000, Australia
Withdrawn
East Bentleigh, 3165, Australia
Withdrawn
Jamaica, 11432, United States
Completed
Boston, 02114, United States
Completed
Baltimore, 21201, United States
Completed
Chai Wan, Hong Kong

Primary Outcome

  • Incidence of radium-223 dichloride related Adverse Events
    date_rangeTime Frame:
    Up to 7 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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)
    date_rangeTime Frame:
    Up to 7 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Incidence of radium-223 dichloride related Serious Adverse Events
    date_rangeTime Frame:
    Up to 7 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Incidence of placebo-related Adverse Events
    date_rangeTime Frame:
    Up to 7 years
  • Severity of placebo-related Adverse Events
    date_rangeTime Frame:
    Up to 7 years
  • Incidence of placebo-related Serious Adverse Events
    date_rangeTime Frame:
    Up to 7 years
  • Incidence of leukemia
    date_rangeTime Frame:
    Up to 7 years
  • Incidence of myelodysplastic syndrome
    date_rangeTime Frame:
    Up to 7 years
  • Incidence of aplastic anemia
    date_rangeTime Frame:
    Up to 7 years
  • Incidence of primary bone cancer
    date_rangeTime Frame:
    Up to 7 years
  • Incidence of any other new primary malignancy
    date_rangeTime Frame:
    Up to 7 years
  • Incidence of bone fractures
    date_rangeTime Frame:
    Up to 7 years
  • Incidence of bone-associated events
    date_rangeTime Frame:
    Up to 7 years
  • Incidence of febrile neutropenia in subjects who receive cytotoxic chemotherapy
    date_rangeTime Frame:
    Up to 7 years
  • Incidence of hemorrhage in subjects who receive cytotoxic chemotherapy
    date_rangeTime Frame:
    Up to 7 years

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