check_circleStudy Completed
Neoplasm Metastasis / Bone and Bones
Bayer Identifier:
16996
ClinicalTrials.gov Identifier:
EudraCT Number:
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
BothAge
18 - N/ATrial summary
Enrollment Goal
255Trial Dates
December 2014 - January 2024Phase
Phase 4Could I Receive a placebo
NoProducts
Xofigo (Radium-223 dichloride, BAY88-8223)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
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Withdrawn | Moscow, 115478, Russian Federation | |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Withdrawn | Hamburg, 20246, Germany | |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Withdrawn | Freiburg im Breisgau, 79106, Germany | |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Withdrawn | Tübingen, 72076, Germany | |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Withdrawn | Kfar Saba, 4428164, Israel | |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Withdrawn | Seoul, 137-701, Korea, Republic Of | |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Withdrawn | München, 81675, Germany | |
Withdrawn | Torino, 10043, Italy | |
Withdrawn | Santiago, 7500921, Chile | |
Withdrawn | Busan, 49241, Korea, Republic Of | |
Withdrawn | Madrid, 28041, Spain | |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Withdrawn | Beer Sheva, 8410101, Israel | |
Withdrawn | Jerusalem, 9372212, Israel | |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Withdrawn | Taunton, TA1 5DA, United Kingdom | |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Withdrawn | Nottingham, NG5 1PB, United Kingdom | |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 Eventsdate_rangeTime Frame:Up to 7 yearsenhanced_encryptionYesSafety Issue:
- 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)date_rangeTime Frame:Up to 7 yearsenhanced_encryptionYesSafety Issue:
- Incidence of radium-223 dichloride related Serious Adverse Eventsdate_rangeTime Frame:Up to 7 yearsenhanced_encryptionYesSafety Issue:
- Incidence of placebo-related Adverse Eventsdate_rangeTime Frame:Up to 7 years
- Severity of placebo-related Adverse Eventsdate_rangeTime Frame:Up to 7 years
- Incidence of placebo-related Serious Adverse Eventsdate_rangeTime Frame:Up to 7 years
- Incidence of leukemiadate_rangeTime Frame:Up to 7 years
- Incidence of myelodysplastic syndromedate_rangeTime Frame:Up to 7 years
- Incidence of aplastic anemiadate_rangeTime Frame:Up to 7 years
- Incidence of primary bone cancerdate_rangeTime Frame:Up to 7 years
- Incidence of any other new primary malignancydate_rangeTime Frame:Up to 7 years
- Incidence of bone fracturesdate_rangeTime Frame:Up to 7 years
- Incidence of bone-associated eventsdate_rangeTime Frame:Up to 7 years
- Incidence of febrile neutropenia in subjects who receive cytotoxic chemotherapydate_rangeTime Frame:Up to 7 years
- Incidence of hemorrhage in subjects who receive cytotoxic chemotherapydate_rangeTime Frame:Up to 7 years
Trial design
Trial Type
InterventionalIntervention Type
OtherTrial Purpose
OtherAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1