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Last Updated: January 17, 2022

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CLINICAL TRIALS PROFILE FOR XOFIGO

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All Clinical Trials for Xofigo

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00667199 ↗ BAY88-8223, Does Response Study in HRPC Patients Completed Bayer Phase 2 2005-05-30 The purpose of this study is to evaluate the efficacy and safety of the investigational radioisotope Radium-223, Xofigo (Alpharadin), in treatment of men with prostate cancer and bone metastases that no longer respond to hormonal treatment.
NCT00667537 ↗ PK in Pts With HRPC & Skeletal Metastes Completed Bayer Phase 1 2007-07-01 Primary objective: To investigate the biodistribution, radiation dosimetry, and pharmacokinetics of two separate intravenous (IV) injections of Xofigo (100 kBq/kg body weight [b.w.] [=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization], 6 weeks apart). Secondary objectives: To determine the safety of IV injections of Xofigo after two separate injections (6 weeks apart), to evaluate treatment response (antitumour effect in osteoblastic bone metastases) of Xofigo treatment consisting of two injections of activity 100 kBq/kg b.w. (=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization), 6 weeks apart and to evaluate long term radiation toxicity and to collect survival data at 6 and 12 months after the first injection
NCT00748046 ↗ Alpharadin™ (Radium-223 Chloride) Safety and Dosimetry With HRPC That Has Metastasized to the Skeleton Completed Bayer Phase 1 2008-08-01 The purpose of the study is to investigate the safety, biodistribution, radiation dosimetry and pharmacokinetics of three intravenous escalating dose levels of Xofigo (Alpharadin).
NCT01070485 ↗ BAY88-8223, Alpharadin, Breast Cancer Patients With Bone Dominant Disease Completed Bayer Phase 2 2010-01-01 The purpose of the study is to investigate if multiple (up to four) intravenous injections of Xofigo (Alpharadin) have any clinically relevant effect on bone markers in breast cancer patients with bone dominant disease who have progressed on endocrine therapy and are no longer considered suitable for endocrine therapy. In addition the safety of Xofigo (Alpharadin) will be assessed.
NCT02097303 ↗ Open Label Phase Two Trial of Radium Ra 223 Dichloride With Concurrent Administration of Abiraterone Acetate Plus Prednisone in Symptomatic Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Bone Metastasis Completed Bayer Phase 2 2014-03-01 This is an open label study designed to examine the effects on concurrent administration of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone in subjects with symptomatic castrate resistant prostate cancer and with bone metastases, in both the pre- and post- chemotherapy setting. Both medications are approved by the US Food and Drug Administration for this indication.
NCT02097303 ↗ Open Label Phase Two Trial of Radium Ra 223 Dichloride With Concurrent Administration of Abiraterone Acetate Plus Prednisone in Symptomatic Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Bone Metastasis Completed Carolina Research Professionals, LLC Phase 2 2014-03-01 This is an open label study designed to examine the effects on concurrent administration of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone in subjects with symptomatic castrate resistant prostate cancer and with bone metastases, in both the pre- and post- chemotherapy setting. Both medications are approved by the US Food and Drug Administration for this indication.
NCT02135484 ↗ Radium 223 in Castrate Resistant Prostate Cancer Bone Metastases Completed Bayer N/A 2014-09-19 The goal of this clinical research study is to learn more about how the study drug alpharadin (Radium-223) works in patients who have CPRC that has spread to the bone.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Xofigo

Condition Name

Condition Name for Xofigo
Intervention Trials
Prostate Cancer 8
Bone Metastases 3
Metastatic Malignant Neoplasm in the Bone 3
Prostatic Neoplasms, Castration-Resistant 3
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Condition MeSH

Condition MeSH for Xofigo
Intervention Trials
Prostatic Neoplasms 23
Neoplasm Metastasis 9
Bone Neoplasms 5
Bone Marrow Diseases 5
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Clinical Trial Locations for Xofigo

Trials by Country

Trials by Country for Xofigo
Location Trials
United States 82
Italy 11
Germany 6
United Kingdom 6
Spain 5
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Trials by US State

Trials by US State for Xofigo
Location Trials
California 8
Pennsylvania 6
Michigan 5
Massachusetts 4
New York 4
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Clinical Trial Progress for Xofigo

Clinical Trial Phase

Clinical Trial Phase for Xofigo
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 2 14
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Clinical Trial Status

Clinical Trial Status for Xofigo
Clinical Trial Phase Trials
Completed 13
Recruiting 8
Active, not recruiting 7
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Clinical Trial Sponsors for Xofigo

Sponsor Name

Sponsor Name for Xofigo
Sponsor Trials
Bayer 17
National Cancer Institute (NCI) 5
University of Utah 2
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Sponsor Type

Sponsor Type for Xofigo
Sponsor Trials
Industry 21
Other 21
NIH 5
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