Radium-223 Dichloride Long-term Follow-up Program

NCT02312960 | Completed Phase 4 Results

• 2 other identifiers: 169962014-002407-25
• Study Type: interventional
• Target: 255
• Locations: 22 countries
• Sites: 117

Brief Summary

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

Conditions

Neoplasm Metastasis / Bone and Bones

Outcome Measures

Primary Outcomes (12)

• Number of Participants With Radium-223 Dichloride-/Placebo-related Adverse Events (AEs)

  Adverse events considered related to radium-223 dichloride or placebo (received in the feeder studies), first arising or worsening on or after the date the participant signed the 16996 informed consent.

  Up to 7 years

• Severity of Radium-223 Dichloride-/Placebo-related Adverse Events (AEs)

  Severity will be measured as per guidelines by Common Terminology Criteria for Adverse Events; Version 4.03 (CTCAE)

  Up to 7 years

• Number of Participants With Radium-223 Dichloride-/Placebo-related Serious Adverse Events

  Serious adverse events considered related to radium-223 dichloride or placebo (received in the feeder studies), first arising or worsening on or after the date the participant signed the 16996 informed consent.

  Up to 7 years

• Number of Participants With Leukemia

  Up to 7 years

• Number of Participants With Myelodysplastic Syndrome

  Up to 7 years

• Number of Participants With Aplastic Anemia

  Up to 7 years

• Number of Participants With Primary Bone Cancer

  Up to 7 years

• Number of Participants With Any Other New Primary Malignancy

  Up to 7 years

• Number of Participants With Bone Fractures

  Up to 7 years

• Number of Participants With Bone-associated Events

  Up to 7 years

• Number of Participants With Febrile Neutropenia in Subjects Who Receive Cytotoxic Chemotherapy

  Up to 7 years

• Number of Participants With Hemorrhage in Subjects Who Receive Cytotoxic Chemotherapy

  Up to 7 years

Study Arms (1)

Arm 1

OTHER

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

Interventions

Data Collection OTHER

No study treatment will be provided in this long term follow up study.

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not applicable to this follow up study

Sponsors & Collaborators

• Bayer: lead

Study Sites (117)

Unknown Facility

Anchorage, Alaska, 99503, United States

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Tucson, Arizona, 85704, United States

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Plantation, Florida, 33324, United States

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Indianapolis, Indiana, 46202, United States

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Ashland, Kentucky, 41101, United States

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New Orleans, Louisiana, 70112, United States

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Shreveport, Louisiana, 71103, United States

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Baltimore, Maryland, 21201, United States

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Boston, Massachusetts, 02114, United States

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Detroit, Michigan, 48201, United States

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Omaha, Nebraska, 68130, United States

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Syracuse, New York, 13210, United States

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Pittsburgh, Pennsylvania, 15215, United States

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Watertown, South Dakota, 57201, United States

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Seattle, Washington, 98109, United States

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Darlinghurst, New South Wales, 2010, Australia

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Westmead, New South Wales, 2145, Australia

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Fitzroy, Victoria, 3065, Australia

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Heidelberg, Victoria, 3084, Australia

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Kortrijk, 8500, Belgium

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Leuven, 3000, Belgium

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Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

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Barretos/SP, São Paulo, 14784-400, Brazil

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São Paulo, São Paulo, 01246-000, Brazil

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Toronto, Ontario, M4N 3M5, Canada

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Montreal, Quebec, H2X 0A9, Canada

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Prague, 128 08, Czechia

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Helsinki, 00290, Finland

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Tampere, FIN-33520, Finland

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Bordeaux, 33076, France

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Nantes, 44805, France

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Nîmes, 30029, France

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Saint-Cloud, 92210, France

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Tours, 37044, France

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Villejuif, 94805, France

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Ulm, Baden-Wurttemberg, 89091, Germany

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Erlangen, Bavaria, 91054, Germany

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München, Bavaria, 81377, Germany

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Rostock, Mecklenburg-Vorpommern, 18107, Germany

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Aachen, North Rhine-Westphalia, 52074, Germany

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Mainz, Rhineland-Palatinate, 55131, Germany

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Dresden, Saxony, 01307, Germany

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Magdeburg, Saxony-Anhalt, 39120, Germany

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Jena, Thuringia, 07747, Germany

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Berlin, 10719, Germany

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Berlin, 12203, Germany

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Bremen, 28277, Germany

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Chai Wan, 0, Hong Kong

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Afula, 1834111, Israel

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Haifa, 3109601, Israel

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Jerusalem, 9112001, Israel

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Petah Tikva, 4941492, Israel

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Ramat Gan, 5262000, Israel

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Tel Aviv, 6423906, Israel

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Zrifin, 7030000, Israel

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Forlì Cesena, Emilia-Romagna, 47014, Italy

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Modena, Emilia-Romagna, 41124, Italy

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Rome, Lazio, 00161, Italy

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Rome, Lazio, 00189, Italy

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Milan, Lombardy, 20133, Italy

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Trento, Trentino-Alto Adige, 38100, Italy

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Matsuyama, Ehime, 791-0280, Japan

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Sapporo, Hokkaido, 003-0804, Japan

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Sapporo, Hokkaido, 060-8648, Japan

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Kanazawa, Ishikawa-ken, 920-8641, Japan

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Yokohama, Kanagawa, 236-0004, Japan

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Yokohama, Kanagawa, 241-8515, Japan

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Kurashiki, Okayama-ken, 701-0192, Japan

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Sayama, Osaka, 589-8511, Japan

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Hidaka, Saitama, 350-1298, Japan

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Kita-Adachigun, Saitama, 362-0806, Japan

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Koto-ku, Tokyo, 135-8550, Japan

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Fukuoka, 811-1395, Japan

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Kumamoto, 860-0008, Japan

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Miyazaki, 889-1692, Japan

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Osaka, 540-0006, Japan

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Bodø, 8092, Norway

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Oslo, 0424, Norway

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Bialystok, 15-027, Poland

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Gliwice, 44-101, Poland

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Warsaw, 02-781, Poland

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Obninsk, 249036, Russia

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Singapore, 119074, Singapore

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Singapore, 168583, Singapore

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Seoul, Seoul Teugbyeolsi, 3080, South Korea

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Seoul, Seoul Teugbyeolsi, 6273, South Korea

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Daegu, 42601, South Korea

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Incheon, South Korea

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Seoul, 138-736, South Korea

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Seoul, 3722, South Korea

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Badalona (Barcelona), Barcelona, 08916, Spain

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Palma de Mallorca, Illes Baleares, 7120, Spain

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A Coruña, 15009, Spain

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Barcelona, 08035, Spain

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Barcelona, 08036, Spain

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Barcelona, 08041, Spain

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Madrid, 28007, Spain

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Madrid, 28040, Spain

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Madrid, 28050, Spain

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Málaga, 29010, Spain

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Pamplona, 31008, Spain

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Seville, 41013, Spain

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Seville, 41071, Spain

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Umeå, 901 85, Sweden

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Kaohsiung City, 81362, Taiwan

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Taichung, 40705, Taiwan

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Taipei, 11217, Taiwan

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Taipei, Taiwan

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Taoyuan District, 33305, Taiwan

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Truro, Cornwall, TR1 3LJ, United Kingdom

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Plymouth, Devon, PL6 8DH, United Kingdom

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Sheffield, South Yorkshire, S10 2SJ, United Kingdom

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Guildford, Surrey, GU2 7XX, United Kingdom

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Sutton, Surrey, SM2 5PT, United Kingdom

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Coventry, Warwickshire, CV2 2DX, United Kingdom

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Bristol, BS2 8ED, United Kingdom

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Cottingham, HU16 5JQ, United Kingdom

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Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Therapeutic Area Head
• Organization: Bayer

clinical-trials-contact@bayer.com

(+) 1-888-8422937

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 9, 2014
• Study Start: December 18, 2014
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: March 25, 2025
• Results First Posted: January 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (3); RU (1); CZ (1); IT (6); DE (12); AU (4); KR (6); ES (13); BE (2); FR (6); IL (7); TW (5); GB (8); CA (2); SG (2); SE (1); FI (2); NO (2); JP (15); BR (3); HK (1); US (15)